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Pumping ProtocolA Guide to Insulin Pump Therapy Initiation

Includes an introduction to continuous glucose monitoring (CGM) and therapy management software

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1Table of Contents

Table of Contents

Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Insulin Pump Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Guidelines for Initial Pump Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Calculate Starting Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

The Bolus Wizard® Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Adjusting Pump Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Basal Rate Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Bolus Adjustments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Infusion Site Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

DKA Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Unexplained High Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Prevention of Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Treatment of Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Special Populations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Therapy Management Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Continuous Glucose Monitoring (CGM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

References and Suggested Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

2

Bruce W. Bode, MD, FACEAn internationally known speaker and author on insulin pump therapy and continuous glucose monitoring, Dr. Bode, a graduate of Emory University School of Medicine, is in private practice with Atlanta Diabetes Associates. He is active in both the Georgia affiliate of the American Diabetes Association and the Juvenile Diabetes Research Foundation. Dr. Bode is also the editor of the American Diabetes Association’s Medical Management of Type 1 Diabetes.

Contributors

Jennifer Kyllo, MDJennifer Kyllo, MD is the Medical Director of the McNeely Pediatric Diabetes Center and Endocrine Clinic at Children’s Hospitals and Clinics of Minnesota. She attended medical school at the University of Minnesota and completed her residency and fellowship at the University of Iowa. Her principal areas of interest include caring for children with diabetes and improving access to new diabetes technology for children.

Francine R. Kaufman, MDFrancine Ratner Kaufman, MD is Chief Medical Officer and VP of Global Clinical, Medical and Health affairs at Medtronic Diabetes and a Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine and the Annenberg School of Communications of the University of Southern California. Dr. Kaufman was president of the American Diabetes Association (2002-03), and serves on the Advisory Council of the Diabetes Branch of the NIH.

While every reasonable precaution has been taken in the preparation of this guide, the author, sponsor and publisher assume no responsibility for errors or omissions, nor for the uses made of the materials contained herein and the decisions based on such use. This document does not contain all of the information necessary for the proper care and treatment of patients with diabetes. As such, no individual may rely on the information presented herein in forming a comprehensive treatment program or in treating any patient with diabetes. No warranties are made, expressed or implied, with regard to the contents of this work or to its applicability to specific patients or circumstances. Neither the author, sponsor, nor the publisher shall be liable for direct, indirect, special, incidental or consequential damages arising out of the use or inability to use the contents of this guide.

3Purpose

PurposeThis booklet is designed for clinicians who are just beginning to prescribe pump therapy, as well as those who already have experience and want to review the latest strategies for optimizing glycemic control with insulin pump therapy. It provides information on proper candidate selection and the indications and protocols for initiating insulin pump therapy. Guidelines for fine-tuning insulin doses and strategies for preventing insulin pump problems are also presented.

Fundamental ConceptsOver the past three decades, insulin pump therapy has proven to be the most effective insulin regimen available for achieving tight glycemic control while minimizing the risk for hypoglycemia.1 It is readily used for the intensive management of adults, adolescents and children with type 1 diabetes and those with insulin-requiring type 2 diabetes.

Effectiveness of insulin pump therapy is attributed to three fundamental principles:

1. Pumps use only rapid-acting insulin for basal and bolus insulin requirements.

Eliminating longer acting insulin helps improve glycemic control during fasting states because:

•Theaction/peaktimeofrapid-actinginsulinismorepredictableandreproduciblethan long-acting insulin.2

•Thetinybasaldosesthatarecontinuouslydeliveredovereachhouraremoreconsistentlyabsorbed by the body.

2. Pumps deliver insulin in two ways, basal and bolus.

•Basal Insulin is a continuous infusion of insulin that is delivered automatically 24 hours a day. The purpose of basal insulin is to cover hepatic glucose production and to maintain glucose stability during fasting states (between meals and during sleep).

•Bolus Insulinisdelivered“on-demand,”bythepatient,forfoodintakeand/ortocorrectglucose levels that are above the patient’s target range, delivered separately or together.

− Food Bolus: Insulin given to cover food or drink that contains carbohydrates.

− Correction Bolus: Insulin given to correct blood glucose (BG) levels that are abnormal.

3. Medtronic pumps use a Bolus Wizard® calculator.

The Bolus Wizard calculator helps make diabetes management and bolus dosing easier and more accurate because it:

•Calculatesthebolusamountforthepatient,accordingtotheirpersonalizedsettings.

•Trackstheamountofactiveinsulinremainingfrompreviousboluses.

•Subtractsactiveinsulinfromcorrectiondosesbeforesuggestingthetotalbolusamount, which helps to prevent lows that result from the stacking of insulin.

•RecordsBGreadings,carbohydratesconsumed,unitsofinsulindeliveredandthetimeeachwas entered. Data can be downloaded into reports for easier, more accurate evaluation.

4 Insulin Pump Therapy

Insulin Pump Therapy

Indications3-5

Type 1 and insulin-requiring type 2 patients who are unable to achieve acceptable glycemic control, including those with:

•ElevatedA1C.

•Glycemicvariability.

•Recurrenthypoglycemia,nocturnalhypoglycemia,activity-inducedhypoglycemia and hypoglycemia unawareness.

•Pregnancy/Pre-pregnancy.

•Recurrentdiabeticketoacidosis(DKA)/recurrenthospitalizations.

•Dawnphenomenon.

•Gastroparesis.

•Patientpreference,meal-timingflexibilityandnormalizationoflifestyle.

•Lowinsulinrequirements(noteasilymeasuredviasyringe).

•Inabilitytoself-administerinsulin(pre-school/gradeschool).

•Inabilitytopredictfoodormealintake(infant/toddler).

Patient Requirements5-10

•Responsibleandpsychologicallystable

•Willingnesstomonitorbloodglucose(BG)aminimumoffourtimesaday

•Willingnesstoquantifyfoodintake

•Willingnesstocomplywithmedicalfollow-up

Benefits3,4,7,11

•Improvedglycemiccontrolanddecreasedglycemicvariability

•Improvedcontrolofdawnphenomenon

•Decreasedseverityandfrequencyofhypoglycemia

•Increasedflexibility,normalizationoflifestyleandsenseofwell-being

Precautionary Areas7

•Hyperglycemiaand/orDKAifinsulininfusionisinterrupted

•Lipohypertrophy(wheninfusionsitesarenotrotatedproperly)

•Infusionsitereactions(rashandskinirritation)orinfections

5Guidelines for Initial Pump Settings

Guidelines for Initial Pump SettingsInsulin pump therapy uses rapid-acting insulin for both basal and bolus insulin requirements.

* Hypoglycemic unawareness or other concerns, use the lower dose .† The percentage split for total daily basal and total daily bolus varies, especially in pediatric populations .

Basal Rate (BR)

Daily Basal Dose ÷ 24 = Hourly BR

Reduced Dose

Based on Daily Injection Dose

Injection Dose x 0.75 = Reduced Dose

Total Daily Basal Dose†

Pump TDD x 40% to 50% = Daily Basal Dose

Pump Total Daily Dose (TDD)

Average of Reduced Dose and Weight Dose*

(Reduced Dose + Weight Dose) ÷ 2 = Pump TDD

Weight Dose

Based on Weight

kg x 0.50 or lb x 0.23 = Wt. Dose

Insulin-to-Carb Ratio (ICR)

Daily Carbs ÷ Daily Bolus Dose = ICR

Total Daily Bolus Dose

Pump TDD - Daily Basal Dose = Daily Bolus Dose

Insulin Sensitivity Factor (ISF)

1700 ÷ Pump TDD = ISF

Guidelines for Transitioning to Pump Therapy

Goal: Eliminate as much intermediate/long-acting insulin as possible before starting pump . •Stopintermediate-actinginsulin12hoursbeforeandlong-actinginsulin24hoursbeforeinitiatingpumptherapy. •Havepatientgiveinjectionsusingsmallamountsofrapid-actinginsulinasneeded(every3to4hours)tokeepBGs

acceptable until pump therapy is initiated . •Insituationswhereintermediateorlong-actinginsulinisnotdiscontinued,programatemporarybasalrateto

deliverareducedbasalamount(50%to90%lessthancalculatedstartingrate)forthefirst12to24hoursoftherapy.

6

Pump Total Daily Dose (Pump TDD)Reduce the current total daily injection dose by 25 percent, calculate the weight dose and then average the two together.

TOTAL DAILY DOSEThe total amount of insulin(basalandbolus)delivered by the pump each day .

BASAL INSULINA continuous infusion of insulin given to cover hepatic glucose production .•Intendedtomimic

pancreatic basal secretion and maintain glucose stability in fasting states (betweenmealsand duringsleep).

•Replaceslong- acting insulin .

•Programmedtomatchpatient’s individual diurnal variation .

BOLUS INSULINGiven on demand by patient, as needed, for carbohydrateintakeandcorrecting abnormal glucose levels .

I N ITIAL PUM P TD DTake average of Reduced and Weight Dose

(Reduced Dose + Weight Dose) ÷ 2 = Pump TDD

E X A M P L E PAT I E N TType 1 Male Weight: 70 kg (154 lb)

Current Daily Insulin Regimen Rapid-acting: 11 units pre-meal x 3 33 u/day Long-acting:20units(Bedtime) + 20u/day

Total Daily Injection Dose = 53 u/day

R E D U CE D D OS EBased on daily injection dose

Injection Dose x 0.75 = Reduced Dose

W E I G HT D OS EBased on weight

kg x 0.5 u = Weight Doseor

lb x 0.23 u = Weight Dose

Reduced Dose

53 u/day x 0 .75 = 40 u/day

Weight Dose

70kgx0.5u=35 u/day or

154 lb x 0 .23 u = 35 u/day

Calculate Starting Doses

Initial Pump TDD

(40u/day+35u/day)÷2=37.5 u/day(Reduced Dose) (Weight Dose) (Pump TDD)


Clinical Considerations for Pump TDD

•Uselessthana25%reductionifdailyinjectiondoseismorethan70%rapid-actinginsulin.•Pediatricpatientswhohavegoodcontroloninjectionsmayrequireaslittleasa5%reduction.•Forchildren&teens,TDDisvariable.Mayrequireasmuchas1.0u/kgtocalculateweightdose.•Hypoglycemiaorhypoglycemiaunawareness,usethelowerofthetwovalues.•Persistenthyperglycemia,elevatedA1Corpregnancy,usethehighervalue.•Erraticglucosecontrol,startingtherapyatdiagnosisorfromoralmedications,useweightmethod.

7

Total Daily Basal and Total Daily BolusFirst, determine the percent of TDD to be delivered as basal insulin and then multiply TDD by that percent. This will give you the Total Daily Basal amount. To calculate Total Daily Bolus subtract the Total Daily Basal amount from the TDD.

Basal RatePump therapy is typically initiated with a single basal rate that is delivered evenly over each hour, 24 hours a day. To calculate the initial basal rate, divide 24 hours into the Total Daily Basal amount.

TOTAL DAILY BASALTotal amount of basal insulin delivered over 24 hours .

TOTAL DAILY BOLUS: Total amount of bolus insulin(foodandcorrection)delivered over 24 hours .

BASAL RATEThe amount of basal insulin programmed to deliver evenly over each hour .

BASAL RATES <1 UNIT/HOURProgram in 0 .025 unit increments .

BASAL RATES >1 UNIT/HOURProgram in 0 .050 unit increments .

BA SALPump TDD x % Basal = Total Daily Basal

BO LUSPump TDD - Total Daily Basal = Total Daily Bolus

I N IT IAL BA SAL R ATETotal Daily Basal ÷ 24 hours = Hourly Basal Rate


E X A M P L E PAT I E N TTotal Daily Basal: 18.75 u/day

E X A M P L E PAT I E N T50% of TDD as Total Daily Basal

Total Daily Basal

37.5 u/day x 0.5 = 18.75 u/day (PumpTDD) (TotalDailyBasal)

Initial Basal Rate

18.75 u/day ÷ 24 hours = 0.78 u/hour (TotalDailyBasal) (HourlyBasalRate)

Start initial basal rate at 0.775 or 0.800 units per hour

Total Daily Bolus

37.5 u/day – 18.75 u/day = 18.75 u/day (PumpTDD) (DailyBasalAmount) (TotalDailyBolus)


Clinical Guidelines for Total Daily Basal and Bolus Percentages

Total Daily Basal Total Daily Bolus

Adults: 40%to50% 50%to60%

Puberty to Adult: 30%to40% 60%to70%

Pre-Puberty to Puberty: 20%to40% 60%to80%

8

Insulin-to-Carbohydrate Ratio (ICR)If a patient on multiple daily injections has established an ICR that provides reasonable post-prandial control, start pump therapy using that ICR. Or, use one of the methods below to calculate the initial ICR. If a patient is not yet carb counting or does not have an accurate food log, use the 450 Rule.

Fixed Gram or Exchanges per Meal MethodFor patients who are not yet carbohydrate counting or who have low cognitive ability, use the Fixed Gram or Exchange per Meal method explained below:

1) Calculate patient’s ICR using the 450 Rule.

2) Instruct patient on number of carbs or exchanges to enter for: a snack, a small meal, a medium size meal, a large meal.

3) Have patient use the Bolus Wizard® calculator to enter current BG and the number of grams or exchanges you told them to use for the size meal they are planning to eat.

This allows non-carb counting patients to use the Bolus Wizard and receive similar benefits to a carb counting patient, making diabetes management and record keeping easier.

INSULIN-TO- CARBOHYDRATE RATIONumber of carbohydrate grams covered by one unit of insulin .

ICR is used to calculate food bolus amounts .

ESTIMATING DAILY CARBOHYDRATE INTAKEHave patients who are not yetcarbcountingkeepa24 hour food log for 4 to 7 days .

Have diabetes educator review food log and estimate average daily carbohydrateintake.

METHOD 1Estimated Daily Carb Intake

Carb Grams ÷ Total Daily Bolus = ICR

M E TH O D 2450 Rule

450 ÷ Pump TDD = ICR

OR


E X A M P L E PAT I E N TEstimated Daily Carbs: 225 grams Total Daily Bolus: 18.75 u/day Pump TDD: 37.5 u/day

Method 1

225 grams ÷ 18.75 u/day = 12 grams/unit

1 unit covers ~ 12 grams of carbohydrate

ICR = 12 grams

Method 2

450 ÷ 37.5 u/day = 12 grams/unit

1 unit covers ~ 12 grams of carbohydrate

ICR = 12 grams

OR


Key Concepts for ICR

•PatientsoftenrequiremorethanoneICRtoobtainoptimalpost-prandialcontrol.

•DifferentICRscanbeprogrammedintotheBolusWizardfordifferenttimesduringtheday. Example:breakfast,lunch,dinner,snacktimes.

9

Insulin Sensitivity Factor (ISF)If a patient on multiple daily injections has an established ISF that currently provides reasonable correction doses, you can start pump therapy using that ISF. Or, use one of the methods below to calculate the initial ISF. For patients who have frequent hypoglycemia or hypoglycemia unawareness, use the 2000 Rule.

INSULIN SENSITIVITY FACTORThe number of mg/dL one unit of insulin lowers glucose .

Usedtocalculate correction bolus amounts .

BG TARGETBG value used in the correction formula when calculating a correction dose .

CORRECTION DOSEAmount of insulin calculated to correct a BG that is above target . Or, the amount of insulin subtracted from a food bolus when the BG is below target .

E X A M P L E PAT I E N TBG Target = 100 mg/dL ISF = 45 mg/dL

I F B G I S A B OV E TA R G E T (160 mg/dL): A positive correction dose is calculated .

(160–100)÷45=1.3units

I F B G I S AT TA R G E T: No correction amount is calculated .

I F B G I S B E LOW TA R G E T (60 mg/dL): A negative correction dose is calculated and subtracted from the food bolus .

(60–100)÷45=–0 .9 units


I S F CO R R E C TI O N FO R M U L A(Current BG – BG Target) ÷ ISF = Correction Dose

E X A M P L E PAT I E N TPump TDD: 37.5 u/day

Method 1

1700 ÷ 37.5 = 45.3 mg/dL

One unit decreases BG ~ 45 mg/dL

ISF = 45 mg/dL

Method 2

2000 ÷ 37.5 = 53.3 mg/dL

One unit decreases BG ~ 53 mg/dL

ISF = 53 mg/dL

OR

METHOD 11700 Rule


M E TH O D 22000 Rule


OR


10

Once the Bolus Wizard is programmed with the patient’s settings, the patient simply enters their current BG and the grams of carbohydrate they plan to eat. The Bolus Wizard uses this information to calculate the total bolus (called the “Estimate Total”) for the patient.

BOLUS WIZARD CALCULATORA feature in the pump that calculates meal and correction boluses and tracksactiveinsulinfor the patient .

ACTIVE INSULINInsulin remaining from previous boluses that continues to have a pharmacodynamic effect and the potential to lower glucose .

BG TARGET RANGEThe range of glucose valuestheBolusWizard uses to determine if a correction dose needs to be calculated .

To determine theBG Target Range:•EstablishthehighBGvaluefortheBolusWizardto use when correcting elevated BGs .

•EstablishthelowBGvalue for it to use when correcting low BGs .

E X A M P L E S O F B O LU S W I Z A R D CO R R E C T I O N C A LC U L AT I O N STarget Range Setting = 90 – 110 mg/dL ISF = 45 mg/dL

A B OV E R A N G E: (175 mg/dL)(175-110)÷45=1.4units(correctionbolus)

B E LOW R A N G E: (72 mg/dL)(72-90)÷45=–0.40units(subtractedfromfoodbolus)

Negative correction amounts are subtracted from food boluses before the Estimate Total is given .

•Moreaccuratebolusdosing

•Tracksactiveinsulin

•Helpspreventstackingofinsulindoses

•Reducesriskoflowsrelatedtostacking

•Keepscomprehensiverecordof: - BG readings - Carbohydrate grams - Insulin doses - Times of each entry

Benefits of using Bolus Wizard calculator12

TheBolusWizardCalculator

Correction Bolus and Bolus Wizard Target RangesWhen a BG reading is above the programmed Target Range, the Bolus Wizard uses the higher value in the range to calculate the correction dose. When a BG is below the Target Range, the Bolus Wizard uses the lower value to calculate the negative or reverse correction dose.

The Bolus Wizard® Calculator

•Insulin-to-CarbohydrateRatio(ICR)

•InsulinSensitivityFactor(ISF)

•BGTargetRange

•ActiveInsulinTime

Bolus Wizard Settings

Multiple target ranges are used to accommodate daytime, nighttime, pre- and post-meal glucose goals. When determining Bolus Wizard target ranges, keep in mind, these are not the same as ADA or AACE BG guidelines; instead they are the values the pump “targets” when correcting high or low BGs.

Clinical Considerations for Setting Initial Bolus Wizard Target Ranges*

Daytime Nighttime

•AdultsandAdolescents(13+yrs) 90–100mg/dL 100–110mg/dL•SchoolAge(6–12yrs) 90–110mg/dL 100–120mg/dL•ToddlertoPre-school(0 –6yrs) 100–120mg/dL 110–130mg/dL•HypoglycemiaUnawareness 100–120mg/dL 110–130mg/dL•Pregnancy 80–90mg/dL 90–90mg/dL

*Modifications to Bolus Wizard Target Ranges should be based on each patient’s clinical history.

11

ACTIVE INSULIN TIMEThe length of time the BolusWizardtracks active insulin after a bolus is given .

IMPORTANT POINTS•Activeinsulinisnever

subtracted from a meal bolus amount .

•Activeinsulinisonlysubtracted from correction bolus amounts .

TheBolusWizardCalculator

Active Insulin TimeThe length of time rapid-acting insulin lowers glucose varies in each individual. Therefore, Active Insulin Time can be adjusted to track for 2, 3, 4, 5, 6, 7 or 8 hours. The 7 and 8 hour Active Insulin times are only needed if regular insulin is used in place of rapid-acting insulin.

The Bolus Wizard tracks and calculates the amount of active insulin based on the patient’s individually programmed Active Insulin Time. When a patient’s BG is above target, the Bolus Wizard subtracts the active insulin from the correction insulin before calculating the Estimate Total.

How the Bolus Wizard Calculates the Estimate TotalWhen a patient enters their BG and carbohydrate grams, the Bolus Wizard does the math, using the patient’s pre-programmed settings (ICR, ISF, Target Range and Active Insulin Time) to calculate the Estimate Total for the patient.

TOTAL BO LUSFood bolus + (Correction bolus - Active Insulin) = Estimate Total

The Bolus Wizard® Calculator

Clinical Considerations for Setting the Active Insulin Time

Adults: 4 to 5 hours • Children: 3 to 4 hours • Pregnancy: 3 to 4 hours

E X A M P L E PAT I E N T

ICR: 12 grams ISF: 42 mg/dL BG Target: 100 – 110 mg/dL Active Insulin Time: 5 hours Food to be Eaten: 24 grams Current BG: 220 mg/dL

1.Calculatesfoodbolus: 24grams ÷ 12 grams/unit = 2 .0 units (foodintake) (carbratio) (foodbolus)

2.Calculatescorrectionbolus: (220 mg/dL – 110mg/dL) ÷ 42 mg/dL/unit = 2 .6 units (BG) (targetBG) (sensitivityfactor) (Correction)

3 . Subtracts active insulin: 2 .6 units – 1 .6 units = 1 .0 unit (correction) (activeinsulin) (adjustedcorrection)

4.Addsfood+adjustedcorrectionforestimatetotal: 2 .0 units + 1 .0 unit = 3 .0 units (foodbolus) (adjustedcorrection) (totalbolus)

Bolus Wizard® Settings

Wizard: OnCarbUnits: GramsCarb Ratios: 12Sensitivity: 42BGTarget: 100–110Active Ins Time: 5 hours

Estimate Details

Estimate total: 3 .0 unitsFoodIntake: 24gramsBG: 220 mg/dLFood: 2 .0 unitsCorrection: 2 .6 unitsActive Insulin: 1 .6 units

12

Evaluating glucose control and adjusting pump settings is a logical, systematic process. It is based on the concept that rapid-acting insulin has a predictable glucose lowering effect, basal insulin covers hepatic glucose production, and bolus insulin covers food intake and the correction of high BGs.

Evaluating and adjusting insulin pump settings is accomplished by reviewing pertinent BG data, insulin delivery and carb intake. This data is typically obtained either by having patients manually writetheinformationonaBGlogsheet,orbyuploadingthepumpintoCareLinkPersonalorProfessionalSoftwareandreviewingtheCareLinkreports.

Likeallinsulinregimens,adjustinginsulinisanongoingprocess.Duringthefirstfewweeks of pump therapy, and any time pump settings need to be re-evaluated, have the patient follow these guidelines.

Patient Guidelines •DuringadjustmentphasescheckBGasfollows:

- Upon waking - Bedtime

- Pre-meal - Mid-sleep (or every 3 to 4 hours during sleep)

- Post-meal (2 hours)

•Avoidsnackingbetweenmeals(unlesstreatingalow).

•Eatlow-fatmealsinwhichcarbgramscanbeaccuratelycounted.

•UsetheBolusWizard®calculatortogiveallboluses.

•UploadpumptoCareLinkPersonalevery3to7days.

•IfnotusingCareLink,recordBGs,carbs,bolusesonlogsheetforreviewevery3to7days.

•Callyourofficeifanylowsoccur(lowsmustbeeliminatedtosuccessfullyfine-tune).

Evaluation Guidelines Evaluate glycemic control by time segments:

•Bedtimetomid-sleep(orevery3to4hoursduringsleep)

•Mid-sleeptowake-up

•Pre-mealtopost-meal(2hour)

•Post-mealtonextpre-meal

•Post-mealtobedtime

CARELINK® PERSONAL SOFTWAREAn online tool that allows patients to upload data from their pump and meter into reports .

CARELINK PROA diabetes therapy management software for personal computers that allows healthcare professionals to upload data from pumps and meters into reports .

CARELINK REPORTSOrganizedgraphsandstatistical tables that provide a historical review of glucose and pump data.CareLinkreportscanhelpmaketheevaluationand adjustment process more efficient .

Adjusting Pump Settings


13Adjusting Pump Settings

Adjustment Guidelines Basal rates, carbohydrate ratios and insulin sensitivity factors are the primary settings that need to be adjusted. While all three are reviewed simultaneously, it is usually best to first focus on getting basal rates (especially overnight) set correctly. The secondary settings, Active Insulin Time and Target Ranges, rarely need to be adjusted, and should not be changed until after primary settings have been verified as correct.

To make adjustments:

•Identifyglycemicrise/fallpatternsandanyotherissuesineachtimesegment.

•Adjustsettingsbasedontheglycemicrise/fallpatternandidentifiedissues.

•Makeone(nomorethantwo)changesatatime.

- Hyperglycemia Adjustments: Make adjustments after observing pattern for 3 to 7 days.

- Hypoglycemia Adjustments: Consider adjusting if any lows occur. Avoiding lows during adjustment phases is key, because lows and the treatment of lows disrupts BG patterns.

•Re-evaluateBGs3to7dayspostadjustmenttoconfirmnootherchangesareneeded.


BEHAVIOR AL CHECKS

❏ Are there 3 or more boluses/day?❏ Are there 4 or more BGs/day?❏ IstheBolusWizard®calculatorbeingused?❏ Is infusion set changed every 2 to 3 days?❏ Is pump suspended less than 1 hour/day?❏ Troubleshootdecisionmaking

❏ Do they use a temp basal for exercise?❏ Are they bolusing before meals?❏ Are they disconnecting appropriately?

THER APY CHECKS

❏ Verify pump settings❏ Verifybasalpercentis<50%ofTDD❏ Evaluateovernightcontrol(basal)❏ Evaluatepre-mealcontrol(basal)❏ Evaluatepost-mealcontrol(carbratio)❏ Are they having significant excursions?

Key Concept

Basalinsulindeliversintinyamountseachhouranditsaffectonglucosetakesplaceoveraperiod of time . Therefore, changes made to basal rates should be programmed to begin 2 to 3 hours prior to the observed BG rise or fall . Goal: Prevent the glycemic excursion from occurring .

Typical diabetes management behaviors and therapy checks that should be assessed prior to adjusting insulin settings are listed below.

14 Basal Rate Adjustments

BEDTIME BG PATIENT GUIDELINESInstruct patient that bedtime BGs should always be at least 100 mg/dL before going to sleep .

FASTING METHOD PATIENT GUIDELINESInstructpatienttoskipamealandcheckBGeveryhour.Neverskipmorethanone meal per day .

NON-FASTING METHOD PATIENT GUIDELINESInstruct patient: •Nottoeatbetweenmeals.•Nottocorrectpost-mealhighs(unless>250mg/dL).

Usedforpatientswhocannotskipmeals(i.e.,children,pregnancy).

Basal Rate AdjustmentsWhen basal rates are set correctly, patients should be able to sleep late, eat late, or even skip a meal without experiencing glycemic excursions.

Overnight Basal Rates Evaluation Guidelines

Assessovernightcontrolbyobservingrise/fallpatternsacrosstimesegments(bedtimeto mid-sleep; mid-sleep to wakeup). Adjust basal insulin to match diurnal variations.

Adjustment Guidelines

Goal: BGremainswithintarget(doesnotriseorfall>30mg/dL)throughthenight.

•IfBGrisesorfalls>30mg/dL:Adjustrateby10–20%,2to3hoursbeforeobservedriseorfall.

•IfBGdropsbelow70mg/dL:Instructpatienttotreatthelowanddecreaserate10–20%.

Obtaining optimal overnight glycemic control minimizes the risk of nocturnal hypoglycemia, allows patients to sleep through the night and wake within target, making evaluation of daytime basal easier since patients are not treating lows or correcting highs.

Daytime Basal Rates: Fasting Method Evaluation Guidelines

Evaluate BGs across skipped-meal time segment (pre-breakfast to pre-lunch, pre-lunch to pre-dinner,orpre-dinnertobedtime).Adjust/addbasalrate(s)basedonrise/fallpatternacross skipped-meal time.


Goal: BGremainsstable(doesnotriseorfall>30mg/dL)duringskipped-mealtime.

•IfBGrisesorfalls>30mg/dL:Adjustrate10–20%,2to3hoursbeforeobservedriseorfall.

•IfBGdropsbelow70mg/dL:Instructpatienttotreatthelowanddecreaserate10–20%.

Daytime Basal Rates: Non-Fasting Method Evaluation Guidelines

Evaluate basal rates by comparing the two-hour post-meal BG to the next pre-meal BG. If a high is corrected, do not include that post- to pre-meal segment in your evaluation.

The following principles apply when evaluating basal rates in a non-fasting state:

•Two-hourpost-mealBGsshouldbe30to60mg/dLhigherthanpre-mealBGs;

•Two-hourpost-mealBGsshouldsteadilydeclineandbewithinpre-mealrangesbynextmeal.


Goal: Post-meal BGs steadily decline and are back within pre-meal target range by next meal.

•IfBGfalls>60mg/dL,ordropsbelowtarget:Lowerrate10–20%.

•IfBGrises,staysthesameordecreases<30mg/dL:increaserate10–20%.

15

WHEN EVALUATING INSULIN-TO-CARB RATIO Instruct patient:•Toeatlow-fatmealswithknowncarbcontent.

•Nottoeatbetweenmeals.

2-HOUR POST- MEAL TARGET•ADA:≤180mg/dL•AACE:≤140mg/dL•Pregnancy:≤120mg/dL

WHEN EVALUATING INSULIN SENSITIVITY FACTORInstruct patient to:•Watchforatimewhen

BG is above target and no insulin has been given or food eaten for ~ 3 hours .

•UseBolusWizard to calculate and give recommended correction dose .

•CheckBGeveryhourforthe next 4 hours .

•Avoideatingordrinkinguntil the 4 hour BG has beenchecked.

Bolus Adjustments

Insulin-to-Carbohydrate Ratios (ICR)Evaluation Guidelines

Evaluate ICRs by comparing each pre-meal BG to its corresponding 2-hour post-meal BG.


Goal: Two-hourpost-mealBGisbetween30mg/dLto60mg/dLhigherthanpre-mealBG.

•If2-hourpost-mealBGhasincreasedmorethan60mg/dLfromthepre-mealBG: DecreaseICR10–20%or1to2grams/unit.

•If2-hourpost-mealBGhasincreasedlessthan30mg/dLfromthepre-mealBG: IncreaseICR10–20%or1to2grams/unit.

Questions to Ask Prior to Adjusting ICR

•Werebolusesmissedoradministeredlate?Bolusesshouldbegivenbeforeeating.

•Didthepatientcountcarbohydratescorrectly?

•DidpatientadheretoBolusWizard®calculatorrecommendations?

Insulin Sensitivity Factor (ISF)Evaluation Guidelines

Evaluate ISF by comparing pre-correction BG to the 2- and 4-hour post-correction BGs.


Goal: Post-correction, 2-hour BG is about halfway to target and at target by 4 hours.

•If2-hourpost-correctionBGisnothalfwaytotargetand4-hourpost-correctionisnot attarget:AdjustISF10–20%asneeded.

Bolus Wizard Target Ranges and Active Insulin TimeBG target ranges and active insulin settings are based on patient history, glycemic awareness and clinical judgment. These settings rarely need to be changed and should only be adjusted after primary settings (basal rates, ICRs and ISF) are correctly set.

Bolus Adjustments

Adjusting ICR and ISF Ratios

WhenworkingwithICRandISFratios:•Todecreasebolusamounts,increasetheratio.•Toincreasebolusamounts,decreasetheratio.Example:For60gramsofcarbohydrateifICRis:1:15=4units;1:12=5units;1:10=6units.

16 Infusion Site Care

PREGNANCYConsider inserting infusion sets in areas of subcutaneous tissue that are not tense from increasing abdominal girth, especially during the third trimester .

Infusion SetsMedtronic offers many types of infusion sets with varying lengths of cannulas and angles of insertion. Generally, when a patient has minimal subcutaneous fat, a shorter cannula or a set that goes in at an angle is used.

Auto-insertion devices designed to ensure proper insertion technique and reduce pain upon insertion are available for most infusion sets. The clinical manager in your area can help you and your patients decide which set is most appropriate.

•Sitesshouldbechangedandrotatedevery2to3days.

•Propersiterotationhelpsto:

- Prevent lipohypertrophy and scar tissue.

- Ensure tissue heals before inserting in that area again.

- Maintain healthy, viable tissue, which enhances consistent insulin absorption.

Patient Guidelines for Insertion and Rotation

Instruct patients to:

•Insertinfusionsetsintoeasy-to-accesssubcutaneoustissue.

•Insertsetsintositesthatareatleast2to3inchesawayfromprevioussite.

•Use“clock”,“M”or“W”methodtohelpensureproperrotation.

•Avoidinsertingintoscartissueorareaswithlipohypertrophy.

•Avoidareassubjecttoexcessivemovementorconstrictedbyclothing.

Commonly Used Infusion Sites Site Rotation Methods

Infusion Site Care

17Infusion Site Care

Infection PreventionInfection is rare when proper insertion guidelines are followed. To minimize the risk of infection encourage the use of good clean technique:

•Washhands

•Cleansitethoroughlywithaskinprepwipe

•Keepallinfusionsetssterile

•Changesetandrotatesiteevery2to3days

If an infection occurs:

•Itisusuallystaphylococcalinnatureandtypicallyrequiresoralantibiotictreatment.

•Ifinfectionsarerecurrent,recommendroutine: - Use of Hibiclens®, followed by alcohol to cleanse the site before inserting the set. - Application of an antibiotic ointment immediately after removing the infusion set.

•Ifanabscessoccurs,performanincision,draintheareaandculturethefluid. - Rule out methicillin-resistant staphylococcus. - Consider using Bactroban® in the nares weekly to minimize recurrent infections.

Skin Irritation

If skin irritation occurs, different treatment approaches are recommended depending on the source of irritant:

•Tape: Change type of tape (i.e., Polyskin®, IV 3000® or silk tape).

•Tubing: Place tape under and over tubing (sandwich technique).

•Soap or Alcohol: Change to antibacterial soap or use Skin Prep™ wipes.

If a patient experiences problems with their infusion set tape, he or she can download a copy of Tape Tips and Site Managementatwww.medtronicdiabetes.com/downloads.Thepatientmayalsocallthe24-HourHelpLineat1.800.646.4633.

Key Point: Instruct patients to wait to insert infusion sets until their skin is completely dry. This helps reduce the risk of skin reactions that can occur when adhesive dressing is placed on a wet site that has been cleansed with a skin prep, cleaner or wipe.

Infusion Site Care

18

ILLNESS INCREASES THE RISK FOR DKASystemic illnesses and localizedinfectionsareoften forerunners to DKA . It is important for patients to clearly understand that basalinsulinisrequiredeven when they are not able to eat or when they are nauseated or vomiting .

DKASince signs and symptoms of DKA are similar to flu orstomachvirus(nausea,vomiting,stomachpain)patientsoftenmistakenausea and vomiting associated with DKA for the flu .

Patients should fully understand that nausea and vomiting can be caused by DKA and they shouldchecktheirBG and monitor their urine orbloodforketonesanytime they experience these symptoms .

DKA Prevention

DKA Prevention Because insulin pump therapy uses only rapid-acting insulin, the onset of diabetes ketoacidosis (DKA) can occur quickly if insulin delivery is interrupted for a period of time. Therefore, all type 1 patients must be educated on DKA prevention strategies. The most important of which are: 1) adhering to a routine BG monitoring schedule (four to six times per day) and 2) never ignoring an unexplained high blood glucose.

Protocol for Treating Hyperglycemia

Have patients follow the “Troubleshooting Guidelines” (found on next page) any time they have unexplained high BGs that do not respond to a correction bolus.

Best Practice: Provide type 1 patients with a prescription for ketone strips prior to pump initiation. TeachandreinforcetheimportanceoftestingforketonesanytimeBGsareabove250mg/dL.

Patients should fully understand the following concepts:

•UnexplainedhighBGsshouldNEVERbeignored.

•TwounexplainedhighBGsinaroworahighBGthatisnotrespondingto a correction bolus may indicate an infusion set or insulin pump problem.

•NauseaandvomitingcanbecausedbyDKA.

•IllnessincreasestheriskfordevelopingDKA.

•Whenill,patientsshouldcheckBGeveryonetotwohours,checkforurineketones every time they urinate, and drink fluids. Staying hydrated helps prevent DKA.

•Neverexercisewhenketonesarepositive.

When DKA does occur, keep in mind that even after DKA has been properly treated and glucose returns to normal ranges, ketones may continue to be present for up to 24 hours.

When BG is ≥250 mg/dL:

If Ketones are Positive Or nausea and/or vomiting is present

•Giveacorrectiondoseviainjection

•Changeinfusionset,reservoirandinsulin

•MonitorBGevery1to2hoursand give insulin via injection until BGs are within target

•If BG is not decreasing, and you have moderate to high ketones, nausea, vomiting or difficulty breathing, call healthcare provider or go to emergency room

The point and time healthcare providers want to be notified varies. Establish a clear protocol for patients to follow.

If Ketones are Negative

•Giveacorrectiondoseviainsulinpump

•RecheckBGinonehour

•IfBGhasnotdecreased - Give a manual injection - Change infusion set, reservoir

and insulin

•ContinuetomonitorBGuntilglucoselevelsare within desired range

The most common causes of unexplained hyperglycemia that does not respond to a correction bolus include: a kinked or displaced cannula, an infusion set or reservoir issue or a “bad” (denatured) vial of insulin.

Check for KETONES and follow these guidelines:

19UnexplainedHighGlucose

TRO U B LE S H O OTI N G G U I D E LI N E S

WhattoCheck QuestionstoAsk If Yes…

Infusion site •Isitred,irritatedorpainful?

•Isitwet,ordoesitsmelllikeinsulin?

Change infusion set, reservoir and insulin

Infusion set tubing •Aretherebubbles(largerthan champagnebubbles)inthetubing?

•Istherebloodinthetubing?

Change infusion set, reservoir and insulin

Connection between reservoir and infusion set

•Arethereleaks/breaks?

•Isconnectionloose/easilymoved?

Change infusion set, reservoir and insulin if unable to correct the problem by tightening

Reservoir •Isitloadedincorrectly?

•Isthereservoirempty?

•Arethereexcessivebubbles?

Change infusion set, reservoir and insulin if unable to correct the issue

Insulin •Hasinsulinvialexpired?

•Hasinsulinbeenexposedtohightemperatures or direct sunlight?

Change infusion set and reservoir using a newvialofinsulin.(Whenindoubt,change itout!)

Checkinsulinpumpsettings

- Bolus Delivery

- Basal Rates

- Time

•Waslastmealbolusmissed?

•Arebasalratessetincorrectly?

•Istime(AM/PM)setcorrectly?

Give correction dose

Reset basal rates

Set time correctly

Insulin pump •Isinsulinpumpnotworkingor inoperable?

•Notsureifinsulinpumphas a problem?

CalltheMedtronicDiabetes24-HourHelpLine at 1 .800 .646 .4633

(The phone number is located on the back of the insulin pump)

Unexplained High Glucose

20 Prevention of Hypoglycemia

Prevention of HypoglycemiaInsulin pump therapy is associated with a marked reduction in the incidence of severe hypoglycemia. This is due to the predictable glucose lowering effects of rapid-acting insulin and the precise and flexible delivery system of an insulin pump. Patients should be taught the following concepts to help further reduce the risk of hypoglycemia.

Check BG a Minimum of 4 to 6 Times a DayRoutine monitoring of pre-meal, bedtime, nocturnal and exercise-related blood glucose levels is essential for safe and effective pump use. Therefore consider: •Periodicmonitoringofpost-mealand3:00AMBGsregardlessofsymptoms. •Conservativecorrectiondosesatbedtimeandpost-exercise. •PeriodicCGMusetoobtaincontinuoustracingsandconfirmtrends,patterns

and missed hypoglycemia.

Use the Bolus Wizard® Calculator for all Bolus DosesUsing this feature can help prevent hypoglycemia that results from the stacking of insulin and the over-correction of highs when there is active insulin remaining from previous boluses. The Bolus Wizard: •Trackstheamountofactiveinsulinremainingfrompreviousboluses. •Subtractsactiveinsulinfromcorrectiondosesbeforecalculatingatotalbolusamount.

BG Target Range Settings can be adjusted to prevent hypoglycemia. •Bedtimetargetrangescanbesethigherthandaytimetargetranges. •Patientswithahistoryofhypoglycemiamayneedahighertargetrangeallday.

Exercise Precautions •MonitorBG -Pre-exercise(BGmustbe>100mg/dL) - Every 30 minutes during exercise - Post-exercise (periodically, until BG lowering effect of exercise has subsided)

•UseTemporaryBasalRate -Startbydecreasingthebasalrate50%onehourbeforeexercisebegins,throughout

the exercise time, and for at least one hour post-exercise. - Adjust temporary basal rate percentage and duration as needed

(varies depending on the intensity and duration of exercise). •Useconservativecorrectiondosesduringthepost-exerciseperiod. •Forintenseenduranceexercise,patientsmayneedtoconsume15gramsofcarbohydrate

for each 15 to 30 minutes of activity. Titrate according to individual glycemic response.

Accurate Carbohydrate Counting Hypoglycemia can result from overestimating carbohydrate intake. Post-meal hypoglycemia is an indication that additional training on carb counting is needed or that the ICR needs to be adjusted.

HYPOGLYCEMIAAny glucose level <70 mg/dL .

MILD HYPOGLYCEMIACharacterizedby symptoms such as sweating, trembling, difficulty concentrating and lightheadedness .

TEMPORARY BASAL RATEAllows basal rate to be immediately increased or decreased for the temporary length of time the patient sets . Can be programmed from 30 minutes up to 24 hours .

SEVERE HYPOGLYCEMIACharacterizedbyaninability to self-treat due to mental confusion resulting in a loss of judgment, lethargy or unconsciousness .

Because the onset and magnitude of symptoms differ greatly in patients from episode to episode, an absolute glucose value cannot be used to measure the severity of a hypoglycemic event.

21

GLUCAGON EMERGENCY KIT PATIENT GUIDELINESInstruct patient to be sure family members, co-workers,friendsareproperly trained on how to administer glucagon .

Manyfindithelpfultowritethe instructions in their own words on a note card andattachittothekit.

HYPOGLYCEMIA PATIENT GUIDELINESInstruct patients to notify the healthcare team if a hypoglycemic event requiringassistanceoccurs.

Treatment of Hypoglycemia

Treatment of HypoglycemiaA common problem in diabetes is over-treating hypoglycemia, which causes hyperglycemia. To help patients prevent highs that result from over-treating, have patients follow a specific strategy, such as the 15-15 Rule, for treating low blood sugars. Encourage the use of glucose tablets for treating lows.

15–15Rule When glucose levels fall below 70 mg/dL:

1) Consume 15 grams of a fast-acting carbohydrate.

2) Recheck BG in 15 minutes.

3)IfBG<70mg/dL,repeatstepsoneandtwountilBGreturnstonormalrange (IfBGis<50mg/dL,patientcanstarttreatmentwith30grams).

Below70mg/dLatMealtimeWhen BG is below 70 mg/dL at mealtime:

•Instructpatientstoeatandmakesureglucoselevelsarewithintargetbeforebolusing.

•Havethemgivethebolusamountthatwascalculatedusingtheirpre-meallow.

Glucagon •Aswithallinsulin-requiringpatients,provideaprescriptionforaGlucagonEmergencyKit

before starting insulin pump therapy.

•Refillonceayearandimmediatelyuponusage.

Reporting Hypoglycemic Events Because some hypoglycemic incidents go unreported, ask about hypoglycemia at every visit

•Sinceyourlastvisit,haveyouhadanyhypoglycemiathatrequiredassistancefromafamilymember?…acoworker?…others?

•Isyourglucagonkitavailable?Wheredoyoukeepit?Whoknowshowtouseit?

Use of Continuous Glucose Monitoring (CGM)ConsidertheuseofCGMinpatientswhohaveahistoryofhypoglycemiaand/orthosewhoareunable to alert others when hypoglycemic symptoms occur.

22 Special Populations

Type 2 PatientsInsulin-requiring, type 2 patients respond favorably to insulin pump therapy. Below are some clinical considerations to assess when placing type 2 patients on pump therapy.

Initiation

Initiation is the same as in type 1 diabetes.

•ThestartingTDDcanbebasedonweight(0.5xkg=TDDUnits).Thismethodhasbeenshownto be effective.

–Startwith50%asbasaland50%asbolus.

–Type2patientstypicallyrequireonlyoneortwobasalrates.

Since many type 2s do not carb-count at initiation, consider using the “Fixed Gram or Exchange per Meal” method (as explained in the ICR section of this book). Set up the Bolus Wizard® using the ICR calculated with the 450 Rule. Evaluate 2-hour, post-prandial control and adjust ICR as needed.

Oral Medications

1) Stop sulfonylureas and meglitinides.

2) Continue metformin, incretin mimetics, and insulin sensitizers, if you choose.

–Onceatgoal,considerdiscontinuinganyoftheabovemedications,oneatatime,toseeif they are actually needed.

–Ifglucoselevelsdecompensatewhendiscontinued,resumethemedication.

Insulin Resistance

1) Some type 2s have marked insulin resistance, aggravated by both lipo and glucose toxicity.

–Onceglucoselevelsnormalize,insulinrequirementsmaydecrease.

–Whenthisoccurs,adjustpumpsettings(basalrate,ICR,ISF)topreventhypoglycemia.

2) In other cases, insulin resistance persists and large insulin requirements continue to be needed.

–Trytoreduceinsulinresistancewithexerciseandbydecreasingconsumption of calories (specifically high carbohydrate-containing foods).

–Considerusinginsulinsensitizersand/orGLP-1agonists.

Special Populations

EASY BOLUS FEATUREAn alternate way to program bolus amounts when the patient does notusetheBolusWizardfeature, does not count carbsorcheckBG before meals .

Modified Pump Start

ForpatientswhoareunabletocountcarbohydratesandcheckBGsbeforemeals,considerthefixed unit per meal bolus method using the Easy Bolus feature .

23Special Populations

Pregnancy Patients Maintaining tight glycemic control during pregnancy is key to preventing complications for both mother and neonate. Consider using Continuous Glucose Monitoring (CGM) throughout the perinatal period to help achieve optimal glucose control. •BGsshouldbemonitoredfrequentlyinpregnancy(pre-andpostmeal,bedtimeandmid-sleep). •Adjustmentstopumpsettingsneedtobemadefrequentlyforcontinuedoptimalcontrol. •Expectinsulinrequirementstosteadilyriseasthepregnancyadvances.Increasedinsulin

requirements are primarily due to the progressive rise in placental hormones which results in increased insulin resistance and decreased sensitivity to insulin action.13

Pre-Conception and 1st TrimesterMaintaining glucose control during organogenesis greatly reduces the risk of fetal anomalies and spontaneous abortion. •Theriskofhypoglycemia,especiallyovernight,increasesduringthefirstfewweeksof

pregnancy and insulin requirements are often less than pre-conception requirements. •Monitorfastingglucoseandcheckurineforketoneseverymorning. –PositiveketoneswithhighBGindicateneedforadditionalbasalinsulin. –PositiveketoneswithnormalorlowBGisindicativeof“starvationketones.”Consider

increasing bedtime snack or adding a midnight snack. •Insituationsofhyperemesis,considerusingasquarewavebolusover30minutessobolus

can be stopped if vomiting occurs.

2nd TrimesterThe placenta is fully developed and growth as well as hormones will begin to steadily rise causing insulin requirement to steadily increase as the pregnancy progresses. •Usuallyrequiresincreaseinbasal,meal,andcorrectioninsulin. •Pumpsettingsmayneedtobeadjustedevery2to3weeks.

3rd Trimester Maintaining tight glucose control throughout the last trimester helps to enhance fetal lung development, prevent fetal macrosomia and reduce the risk of neonatal hypoglycemia (post-delivery). •Insulinrequirementstypicallyincreaseeveryweek(duringthelastfewweeksofgestation).

Labor and DeliveryPatients can remain on pump throughout labor and delivery. •BGsshouldbemonitoredeveryhourandsmallbolusesgiven(ifneeded)tokeepglucose

in desired range.

Post-PartumImmediately after delivery and up to 24 hours post-delivery, insulin requirements decrease significantly. Therefore, basal rates, ICR, ISF and Target Ranges should be reduced to pre-conception settings or to at least half the current settings.

BreastfeedingBG levels can drop dramatically during breastfeeding. •Instructmotherto: –MonitorBGscloselyduringandforatleastanhourafternursing. –Alwaysdrinkandeatwhilebreastfeeding. –Consideruseoftemporarybasalrate(reductionupto50%)foranhourpost-nursing. –ConsideruseofCGM.

Special Populations

SQUARE WAVE BOLUSA feature that allows the patient to deliver a bolus over an extended period of time . Can be programmed to deliver in 30 minute increments from 30 minutes up to 8 hours .


Pediatric PatientsDiabetes brings unique challenges in the pediatric, adolescent and young adult age ranges. Depending on cognitive maturity and development skills, the need for increasing independence and the eventual transition to adult care, there is variability in parental/caregiverinvolvementnecessaryforinsulinpumpmanagement.

Special Populations

PE D IATR I C G U I D E LI N E S

Age Knowledge/Skills/Attitudes DiabetesandPumpManagement

Birth to 3 years of age, infants and toddlers

•Inherenttrustinparents/caregivers

•Rapidchangesincognitiveandmotorskills,nutritionrequirements,sleep/wakepatterns,andacquisitionofdevelopmentalmilestones

•Unawareandunabletocommunicateanyissues with health and diabetes/glucose levels

•Tempertantrumsmaybefrequentandassociatedwithdiabetestasks

•Pumpsabletodeliversmalldosesofinsulin with accuracy

•Issueswithpumpplacement,infusionsites,tubing,skinandchildacceptance

•Childcannotunderstandrequirementsofdiabetes management

•Erraticfoodintake,activity,mood,behavior

•Parents/caregiversmustdoalldiabetesmanagementtasks

•Riskandfearofhypoglycemia

3–6 years of age, preschool

•Beginstoshowsomeminimalunderstandingof diabetes procedures and management issues, such as nutrition

•Mightbegintorecognizehypoglycemiaandtell others

•Canhavenegativeattitudes

•Overallstilllacksmotorskillsandcognitiveability to contribute to diabetes management

•Beginstorealizehavingdiabetesisdifferent

•Childincreasinglyawareofpresenceofdevices, early understanding as to need to protect devices

•Moreinteractionwithpeerswhoareinterestedin devices as well

•Interactswithdecisionsastowhichfingertocheckglucose,wherepumpiswornandinfusion set placed

•Startstoaskaboutfooditemsandiftheycanbe eaten, and if bolus must be given

7–11 years of age, school-aged

•Increasingawarenessoftasksandgoalsofdiabetes management and ability to do them

•Stillreliantonparents/caregiversfordiabetesdecisions

•Mightstrugglewithbeingdifferentandbeginto be self-conscious about diabetes

•Mightbeangryordepressedaboutdiabetes

•Emergingabilitytocarbcount,takeboluses

•Increasingabilitytomanageinfusionset,hooks/unhooks

•Moretimeawayfromparents/primarycaregivers

•Abletoprotectdevices

•Abletodobloodglucosetesting,andknowsnumbers/goals

•Someawarenessastoroleofexerciseinglucose control

25

PE D IATR I C G U I D E LI N E S

Special Populations

Special Populations

Byage12,suggestthatyourpatients/parentsholdaweeklydiabetesmeeting.Ratherthanparentsquizzingthechildonwhat they are doing all day long, they should upload pump and meter data to review reports together. Determine number of BGs, boluses/day,useofBolusWizard,infusionsitechange,carbentries.Usethereportstoassessbehavior,rewardimprovement, and identify adherence problems.

Age Knowledge/Skills/Attitudes DiabetesandPumpManagement

12–15 years of age, young adolescents

•Understandsgoalsofdiabetesmanagement

•Diabetesaffectedbypubertybothphysiologically and psychologically

•Rebellionandrisktakingbehavior

•Peergroupidentificationpreeminent

•Issueswithbodyimage/weight/ disordered eating

•Moreindependence,parentalconflict

•Insulinrequirementsincreasesignificantly

•Erraticeatingandsleepingbehaviors

•Forgetsboluses

•Beginningoftransitionofmajorityofdiabetescare to child, although strong parent/care giver presencestillrequired

•Self-consciousaboutpump/diabetes,mighthide diabetes and devices

•Candomostdiabetes/pumptasks,exceptmight have trouble with changing basal rates and bolus doses

16–21 years of age, older adolescents

•Emergingindependence

•Decideseducation,livinglocation,longtermgoals/jobs/relationships

•Risktakingbehavior,psychologicalissues

•Needtofollowsafedrivingprinciples

•Beginstofullycontrolandmanagediabetes,with parental involvement still present but minimal

•Beginstoberesponsibleforpumpsupplies,health care appointments

•Preparestotransitiontoadultcare

Resources

TheNationalDiabetesEducationProgramwebsite(http://ndep.nih.gov/)hascomprehensiveinformationregardingrightsof children with diabetes in school . There are guides for school nurses, teachers, coaches, administrators, parents and students . All diabetes management and safety information is covered, including pump therapy .


Hospitalized PatientsIn general, patients who self-manage on insulin pump therapy prior to hospitalization prefer to stay on the pump when hospitalized. Having patients self-manage their own therapy is practical and easier for staff, as long as the patient remains mentally alert, psychologically sound and physically able.

If a hospital does not have a protocol for managing patients on insulin pump therapy, provide orders upon patient admission.

Orders should include:

•Rxforavialofrapid-actinginsulin(suppliedbyhospitalpharmacy).

•Currentsettings(BasalRates,ICR,ISF,TargetRangeandActiveInsulinTime).

•BGmonitoringrequirements:

- Frequency and if monitoring is to be performed by patient or staff.

- Documentation of BG readings.

- Glucose levels (upper and lower) at which treatment is required.

- Hypoglycemia protocol

- Hyperglycemia protocol

-Events/glucoselevelsforwhichyouoryourofficeshouldbenotified.

•Alternateinsulinregimenforprocedures:

-Lastinglongerthan2hoursandrequirepumpremoval/discontinuation.

- Requiring fasting (basal insulin continues to be needed).

- Requiring sedation (intravenous insulin should be started just before discontinuing the pump).

•Instructionstoremoveinfusionset,sensor,pumpandtransmitterandleaveoutsideofimagingroom for procedures involving MRI, CT scans, X-Ray (reconnect pump upon completion).

•Proceduretofollowifpatientstatuschangesandisunabletoself-manage.

•Frequencyforinfusionsiteandreservoirchangetobecompletedbypatient.

•Troubleshootingresourcessuchas:

-MedtronicHelpLinenumber1.800.646.4633(locatedonbackofpump).

- Family member who is well versed in pump therapy.

- Your office staff contact.

Hospitals do not typically stock insulin pump supplies. Instruct patients to bring enough infusion sets and reservoirs to change their infusion site every 2 to 3 days during hospitalization.

Special Populations

27TherapyManagementSoftware

Meter BG Reading Carbohydrate Gram Entries

Patient checks BG, enters carbohydrates and boluses simultaneously

Basal Rate Change Bolus Delivery

Therapy Management SoftwareAdvances in technology have now made it possible to electronically capture glucose data necessary for effective evaluation. CareLink®TherapyManagementSoftwareorganizescaptureddata(BGvalues,bolusamounts,basalrates,carbintake)intomeaningful reports for a historical, comprehensive review of the “cause-and-effect” relationship between these parameters.

Ask patients to upload their meter and insulin pump regularly. Review reports at each visit.

ThereportsthatfollowareavailablethroughCareLinkProSoftware.

Example of Daily Detail ReportDisplays each day’s pump and BG meter information and lists the details (time, amount, type) of each bolus that was given.

28 Adherence Report

SuspendDuration(h:mm)

TubingAmount (U)

TubingFills

CannulaAmount (U)

CannulaFillsRewindOverridden

WithCorrection

WithFood

BolusWizardEvents

ManualBoluses

SensorDuration(h:mm)

BGReadings

Fill EventsBolus EventsGlucose Measurements

Adherence (1 of 1)6/2/2010 - 6/15/2010 Data Sources: Paradigm Revel - 523

23583Wednesday6/2/2010

3793Thursday6/3/2010

3474Friday6/4/2010

7.610.62156106Saturday6/5/2010

3695Sunday6/6/2010

2573Monday6/7/2010

56105Tuesday6/8/2010

9.110.511228106Wednesday6/9/2010

3596Thursday6/10/2010

13475Friday6/11/2010

166137Saturday6/12/2010

8.410.31156114Sunday6/13/2010

12575Monday6/14/2010

2563Tuesday6/15/2010

0m8.4U/fill30.4U/fill

439.8%34.1%63.4%8.8/day0.0/day4.8/daySummary

Partial day Note: Partial days will not be included in summary averages. Days on which a time change occurred are considered to be partial days.

Glucose Measurements This section displays frequency of BG meter tests and duration of glucose sensor tracing information.

Bolus Events This section captures the patient’s use of the Bolus Wizard® calculator including the frequency of manual boluses and overrides.

•ManualBolus:Ahighincidenceofmanual boluses indicates under-utilization of the Bolus Wizard calculator.

•BolusWizardOverrides:Maybeappropriate,butshould always be investigated as they may indicate the need for additional patient education, or the need to assess insulin pump settings.

Fill (Priming) Events This section is used to determine if the patient is rewinding and priming the insulin pump appropriately.

•Rewindinglessthanonceeverythreedays indicates extended use of infusion sets or insulin

Suspend Duration Use this section to evaluate if suspend time is reasonable. Investigate frequent suspends and suspend times greater than one hour.

2

2

3

3

4

4

1

1

Example of Adherence ReportProvides new insights into a patient’s self-management behavior and helps confirm optimal device use.

29

Example of Sensor and Meter Overview Report

Meter Overlay Displays BG meter readings to assist in identifying excursionsand/orpatterns.

Statistics Table Displays BG meter, sensor glucose, carbohydrate, and insulin statistics over the reporting period.

Bedtime to Wake-up Meter Overlay Displays BG meter readings from bedtime to wake-up to help identify overnight patterns.

Meal Meter Overlay Realigns BG meter readings around meals (at the time carbohydrates are entered into the Bolus Wizard) to assess pre- and post-meal control.

2

3

4

1

SensorandMeterOverviewReport

6/2/2010 - 6/15/2010Sensor & Meter Overview (2 of 3)

Data Sources: Paradigm Revel - 523

Avg Carbs/Insulin: 12.2g/U Avg Insulin: 1.7U Avg Carbs: 20g

Meals Analyzed: 19 Dinner: 4:00 PM - 10:00 PM


Meals Analyzed: 11 Lunch: 11:00 AM - 3:00 PM


Meals Analyzed: 9 Breakfast: 6:00 AM - 10:00 AM

Wake-up: 5:00 AM - 9:00 AMBedtime: 8:00 PM - 12:00 AM

Bedtime to Wake-up

24-Hour Meter Glucose Overlay - Readings & Averages (mg/dL)

52%12.0Avg Daily Bolus (U)

48%11.0Avg Daily Basal (U)

± 1.723.0Avg Total Daily Insulin (U)

11.0Carbs/Bolus Insulin (g/U)

± 23134Avg Daily Carbs (g)

Avg AUC < 70 (mg/dL)

Avg AUC > 140 (mg/dL)

Sensor Avg (mg/dL)

5%3Readings Below Target

51%33Readings Above Target

4.8/day65BG Readings

± 56 147Avg BG (mg/dL)

- 6/156/2Statistics

Meter Glucose Overlay Bedtime to Wake-Up and Meal Periods – Readings & Averages (mg/dL)

Off chart Average within target range Average outside target rangeBG readingBG reading

Breakfast Example

One hour pre-meal

Target BG Range* (70–140 mg/dL)

6/2/2010 - 6/15/2010Sensor & Meter Overview (2 of 3)









Bedtime to Wake-up









Sensor Avg (mg/dL)





- 6/156/2Statistics


Off chart Average within target range Average outside target rangeBG readingBG reading 5 hours post-meal

9 meals over 14 days

Average daily carb intake for breakfast

Average daily insulin given for breakfast

Average carb to insulin ratio for breakfast

Meal bolus given

Average pre-meal glucose in target

Average post-meal glucose in target at 2 and 4 hours

Statistics6/2/2010 - 6/15/2010Sensor & Meter Overview (2 of 3)









Bedtime to Wake-up









Sensor Avg (mg/dL)





- 6/156/2Statistics


Off chart Average within target range Average outside target rangeBG readingBG reading

Average BG with standard deviation

Number of BGs for the reporting period and average number of BGs/day

Number of BGs above and below target* as well as percent of total BGs above and below target

Average carbs per day when using the Bolus Wizard® calculator

Average units of insulin per gram of carbohydrate when using the Bolus Wizard calculator

Average total number of units of insulin per day

Average number of units of basal insulin per day with percent of total

Average number of units of bolus insulin per day with percent of total

12

43

*Targets determined by provider during report setup

Displays blood glucose meter readings and statistics to allow for identification of glycemic excursions and patterns.

30 LogbookReport

ExampleofLogbookReport

Logbook Cell Section Each cell contains up to three numbers:

•TopNumber:BGmeterreading

•MiddleNumber:Carbohydrates

•BottomNumber:BolusInsulinDelivered

Meals can be quickly identified by looking for the carbohydrate amounts (highlighted in black).

Daily Totals Summarizes the following values from each day of the reporting period:

•Average:DisplaysthetotalnumberofBGmeterreadings taken and the BG meter average.

•Carbs:Displaysthetotalamountofcarbohydratesentered into the Bolus Wizard.

•Insulin:Displaysthetotalamountofinsulindelivered and the percentage delivered as a bolus.

1 2

Logbook Cell Section

Daily Totals

Carbs: Displays the total amount of carbohydrates entered into the Bolus Wizard® calculator.

Insulin: Displays the total amount of insulin delivered and the percentage delivered as a bolus.

Average: Displays the total number of BG meter readings taken and the BG meter average.

Top Number: BG Meter Reading highlighted if above or below target.*

Middle Number: Carbohydratesin black background

Bottom Number: Bolus insulin delivered

DinnerLunchBreakfast

6/2/2010 - 6/15/2010

Logbook (1 of 1)Data Sources: Paradigm Revel - 523

Daily Totals11 PM10 PM9 PM8 PM7 PM6 PM5 PM4 PM3 PM2 PM1 PM12 PM11 AM10 AM9 AM8 AM7 AM6 AM5 AM4 AM3 AM2 AM1 AM12 AM

Average (3):

Carbs: 118gBolus: 51%Insulin: 22.9U

160mg/dL

0.23

153

0.701.5018

2.0525

2.9530

147

0.10

180

1.3515

2.7030

Wednesday6/2/2010

Average (3):


190mg/dL

3.1525

214

2.0525

2.0024

3.0530

202

1.0512

0.385

153Thursday6/3/2010

Average (4):


133mg/dL

0.18

131

2.5030

0.85

192

3.3040

0.738

0.03

104

2.3030

105Friday6/4/2010

Average (6):


214mg/dL

2.0525

3.1538

174

1.20

286

1.25

266

0.8310

3.7545

0.637

Saturday6/5/2010

Average (5):


137mg/dL 110

1.2515

1.6520

1.3316

0.23

128 170

5.0060

0.75

168

2.5028

0.05

108Sunday6/6/2010

Average (3):


140mg/dL

1.1514

3.7545

1.60

247

3.1538

1.4516

63Monday6/7/2010

Average (5):


169mg/dL

0.23

156

0.8310

1.2515

3.1835

126

1.2515

2.5030

0.75

212

2.3526

1.00

223Tuesday6/8/2010

Average (6):


110mg/dL

0.5814

113

1.0012

3.8046

1.3032

75 99

1.0012

100

2.7030

114

0.50


Average (6):


123mg/dL

1.3016

0.658

96

2.0525

0.75

205

2.5030

84

2.8530

132

0.20


Average (5):


147mg/dL

2.0525

1.75

261

0.658

3.7545

101

2.7030

0.30

136Friday6/11/2010

Average (7):


186mg/dL

3.7545

0.8310

1.6310

205

0.90

252

3.7545

0.38

147 167

3.0540

0.68

174Saturday6/12/2010

Average (4):


103mg/dL

1.0012

170

2.0030

2.5030

0.10

71

0.8310

3.3040

101

2.1524

71Sunday6/13/2010

Average (5):


114mg/dL 101

1.6520

4.4845

166

5.0060

78

2.7060

58Monday6/14/2010

Average (3):


97mg/dL

0.587

85

2.0525

2.6034

64

3.1538

2.7030

0.28

141Tuesday6/15/2010

Time change

< 70mg/dL

> 140mg/dL Multiple readings (most extreme shown)

Pump rewind

Suspend

Manual bolus or bolus with correction Skipped meal

Partial day

Other

Exercise


6/2/2010 - 6/15/2010



Average (3):


160mg/dL

0.23

153

0.701.5018

2.0525

2.9530

147

0.10

180

1.3515

2.7030

Wednesday6/2/2010

Average (3):


190mg/dL

3.1525

214

2.0525

2.0024

3.0530

202

1.0512

0.385

153Thursday6/3/2010

Average (4):


133mg/dL

0.18

131

2.5030

0.85

192

3.3040

0.738

0.03

104

2.3030

105Friday6/4/2010

Average (6):


214mg/dL

2.0525

3.1538

174

1.20

286

1.25

266

0.8310

3.7545

0.637

Saturday6/5/2010

Average (5):


137mg/dL 110

1.2515

1.6520

1.3316

0.23

128 170

5.0060

0.75

168

2.5028

0.05

108Sunday6/6/2010

Average (3):


140mg/dL

1.1514

3.7545

1.60

247

3.1538

1.4516

63Monday6/7/2010

Average (5):


169mg/dL

0.23

156

0.8310

1.2515

3.1835

126

1.2515

2.5030

0.75

212

2.3526

1.00

223Tuesday6/8/2010

Average (6):


110mg/dL

0.5814

113

1.0012

3.8046

1.3032

75 99

1.0012

100

2.7030

114

0.50


Average (6):


123mg/dL

1.3016

0.658

96

2.0525

0.75

205

2.5030

84

2.8530

132

0.20


Average (5):


147mg/dL

2.0525

1.75

261

0.658

3.7545

101

2.7030

0.30

136Friday6/11/2010

Average (7):


186mg/dL

3.7545

0.8310

1.6310

205

0.90

252

3.7545

0.38

147 167

3.0540

0.68


Average (4):


103mg/dL

1.0012

170

2.0030

2.5030

0.10

71

0.8310

3.3040

101

2.1524

71Sunday6/13/2010

Average (5):


114mg/dL 101

1.6520

4.4845

166

5.0060

78

2.7060

58Monday6/14/2010

Average (3):


97mg/dL

0.587

85

2.0525

2.6034

64

3.1538

2.7030

0.28

141Tuesday6/15/2010

Time change

< 70mg/dL


Pump rewind

Suspend


Partial day

Other

Exercise


6/2/2010 - 6/15/2010



Average (3):


160mg/dL

0.23

153

0.701.5018

2.0525

2.9530

147

0.10

180

1.3515

2.7030

Wednesday6/2/2010

Average (3):


190mg/dL

3.1525

214

2.0525

2.0024

3.0530

202

1.0512

0.385

153Thursday6/3/2010

Average (4):


133mg/dL

0.18

131

2.5030

0.85

192

3.3040

0.738

0.03

104

2.3030

105Friday6/4/2010

Average (6):


214mg/dL

2.0525

3.1538

174

1.20

286

1.25

266

0.8310

3.7545

0.637

Saturday6/5/2010

Average (5):


137mg/dL 110

1.2515

1.6520

1.3316

0.23

128 170

5.0060

0.75

168

2.5028

0.05

108Sunday6/6/2010

Average (3):


140mg/dL

1.1514

3.7545

1.60

247

3.1538

1.4516

63Monday6/7/2010

Average (5):


169mg/dL

0.23

156

0.8310

1.2515

3.1835

126

1.2515

2.5030

0.75

212

2.3526

1.00

223Tuesday6/8/2010

Average (6):


110mg/dL

0.5814

113

1.0012

3.8046

1.3032

75 99

1.0012

100

2.7030

114

0.50


Average (6):


123mg/dL

1.3016

0.658

96

2.0525

0.75

205

2.5030

84

2.8530

132

0.20


Average (5):


147mg/dL

2.0525

1.75

261

0.658

3.7545

101

2.7030

0.30

136Friday6/11/2010

Average (7):


186mg/dL

3.7545

0.8310

1.6310

205

0.90

252

3.7545

0.38

147 167

3.0540

0.68


Average (4):


103mg/dL

1.0012

170

2.0030

2.5030

0.10

71

0.8310

3.3040

101

2.1524

71Sunday6/13/2010

Average (5):


114mg/dL 101

1.6520

4.4845

166

5.0060

78

2.7060

58Monday6/14/2010

Average (3):


97mg/dL

0.587

85

2.0525

2.6034

64

3.1538

2.7030

0.28

141Tuesday6/15/2010

Time change

< 70mg/dL


Pump rewind

Suspend


Partial day

Other

Exercise

*Targets determined by provider during report setup

1

2

Provides logbook information in an hour-by-hour format to help identify repeated patterns and possible causes for glycemic excursions.

31Device Settings Report

Example of Device Settings Report

Basal Settings Displays the patient’s basal rates at the time the patient’s device was uploaded.

Bolus Settings Displays the patient’s bolus settings at the time the patient’s device was uploaded.

Sensor Settings Displays the patient’s sensor settings at the time the patient’s device was uploaded.

Utilities Displays the patient’s alert type and low reservoir warning settings at the time the patient’s device was uploaded.

Notes Section can be used to record notes for patient records, to provide comments and recommendationsforpatienttherapy,and/or to record documentation for health insurance providers.

2

3

4

5

1

Displays insulin pump and sensor settings.

Thursday 6/17/2010 7:56 AMDevice Settings Snapshot

OffBlood Glucose Reminder

OnDual/Square (Variable)

10.0 UMaximum Bolus

--Insulin Concentration

3:00Active Insulin Time(h:mm)

g, mg/dLUnits

OnBolus Wizard

Bolus

10.900 U24-HourTotal 8.713 U24-Hour

Total 12.188 U24-HourTotal

0.55022:00

0.42519:00

0.37516:00

0.4258:30

0.4256:00

0.5003:30

0.5501:00

0.5250:00

U/hrTIME

12.021:00

12.017:30

12.011:30

11.06:30

13.00:00

RatioTIME

9011:00

1205:00

950:00

SensitivityTIME

115 9022:00

100 805:00

115 900:00

HighLowTIME

mg/dLBG Units

0000000Transmitter ID

OnSensor

NoneGraph Timeout (h:mm)

0:20Missed Data/Weak Signal(h:mm)

140 70AUC Limit: Low | High

(mg/dL)

1:00Calibration (Alert) Repeat(h:mm)

0:30Calibration Reminder(h:mm)

--Auto Calibration

Pattern A Pattern B

Utilities

Sensor

Blood GlucoseTarget (mg/dL)

Insulin Sensitivity(mg/dL per U)

Carbohydrate Ratio(g/U)

0.37518:00

0.3258:00

0.3755:00

0.4003:30

0.4250:00

U/hrTIME

0.52519:00

0.42515:30

0.4756:30

0.5754:30

0.6001:00

0.5500:00

U/hrTIME

20 UAmount

Insulin UnitsLow Reservoir Warning

Beep MediumAlert Type

0.10 UEntry (Step)

OffEasy (Audio) Bolus

Percent of BasalTemp Basal Type

2.00 U/hrMaximum Basal Rate

Basal

Standard (active)

----

End(h:mm)

Start(h:mm)

Off

MissedBolus

Reminder

4.0 4.0Rate Alert: Fall | Rise

(mg/dL/min)

1515Low | High (mins)

OnPredictive Alert

1:300:20Alert Repeat

220 7522:00

175 756:00

200 750:00

High(mg/dL)

Low(mg/dL)TIME

OnGlucose

Alerts

Notes

Data Source: Paradigm Revel - 523

1 2 3

54

32

Recorder

Docking Station

ContinuousGlucoseMonitoring

Continuous glucose monitoring measures glucose levels in the interstitial fluid and provides a record of glucose readings 24 hours a day. These glucose tracings detail the patient’s daily glycemic control and provide insight into trends and patterns that are often missed with finger-stick monitoring alone. CGM technology can help clinicians and patients make more informed decisions regarding diabetes management.

There are two types of CGM systems: Professional and Personal.

Professional CGMProfessional CGM systems are owned and managed by healthcare providers and can be used on multiple patients. Each system consists of a glucose sensor (temporarily inserted into subcutaneous tissue and replaced after each use) and a small recording device that attaches to the sensor. These systems are designed for periodic use and provide detailed continuous glucose data for retrospective evaluation.

During the evaluation period, the patient’s glycemic levels (blinded to the patient) are recorded continuously. At the end of the evaluation period, the glucose data is uploaded by the healthcare providertoCareLink® iPro®, where it is compiled into reports.

These reports provide comprehensive information about glycemic control. Including:

•24-Hourcontinuousglucosetracingsfortheentireevaluationperiod

•Markersthatindicatemealtimesandmedicationstaken

•Overlaysofpost-prandial(breakfast,lunchanddinner)andovernightglucosetracings

•Hyper-andhypoglycemicareaunderthecurve(AUC)data

•Piechartssummarizingglycemiccontrolanddistributionofhyper-andhypoglycemia

These reports provide a historical review of glycemic trends and patterns, allowing clinicians to retrospectively and objectively evaluate a patient’s glucose control and make more informed therapy management decisions.

Continuous Glucose Monitoring (CGM)

ROUTINE USEConsiderquarterlyevaluations, as a compliment to A1C, for type 1 and type 2 .

PROCESS•HCPplacespatient onCGM.

•PatientwearsCGM 3daysandchecksBG 3 to 4 times/day .

•PatientreturnsfordownloadofCGMandglucose meter data .

•Datausedfor: - Glycemic evaluation . - Therapy modification . - Patient education and

consultation .

DOCKING STATIONCharges, downloads and troubleshoots the Recorder .

RECORDERRecords up to 288 sensor glucose readings every 24 hours .

33ContinuousGlucoseMonitoring

*Theinsulinpumpisindicatedforpersonsofallagesrequiringinsulin.TheREAL-TimeContinuousGlucoseMonitoringcomponentsoftheMiniMedParadigm®REAL-TimeInsulinPumpandContinuousGlucoseMonitoringSystemareindicatedforages7yearsorolder.Aversionof the product specially designed for children is indicated for patients ages 7 to 17 .

Glucose Sensor

Target Range

Trend Graph

Sensor Glucose Value

Trend Arrow

Transmitter

Continuous Glucose Monitoring (CGM)

Personal CGMPersonal CGM systems are owned and operated by the patient. These systems consist of the glucose sensors, a transmitter (sends glucose data to a monitor) and a small external monitor. The monitor displays the patient’s most recent glucose reading (updated every 5 minutes) and a continuous tracing of the past 24 hours of glucose readings. There are two types of Personal CGM: one is a stand-alone device, and the other is integrated into the insulin pump.

Indications for Personal CGM*

Patients on MDI or insulin pump therapy who check BG four or more times a day and who have:

•A1Cabovegoal(non-pregnancy>7%,preconception>6.5%,pregnancy>6%).

•Historyoffrequenthypoglycemiaorhypoglycemiaunawareness.

•Markedglucosevariabilitywithmultipleglucosereadingsoutsidethedesiredrange.

Patient Requirements for Starting CGM

The same as insulin pump therapy, plus:

•Willingnesstocalibratetheglucosesensoraminimumofthreetofourtimesaday.

•Willingnesstovalidatesensorglucose(SG)valueswithBGtestpriortomakingtreatmentdecisions.

Considerations Before Starting CGM

•Understandingofimportanceofglucosetrendsversus“point-in-time”BGvalues.

•Understandingofsensorglucose(SG)versusbloodglucose(BG)andthepotentialdifferences in the two values.

•Insurancecoverageorabilitytopayout-of-pocket.

The full benefit of CGM is best realized when current data and historical data are utilized in concert.

TARGET RANGEThe upper and lower glucose values a patient sets for the monitor to alarm when their glucose reaches that level .

SENSOR GLUCOSE VALUEThe patient’s most recent sensor glucose reading .

TREND GRAPHA tracing of the past 24 hours of glucose readings .

TREND ARROWAn arrow or arrows that indicate the direction and rate of glucose change .

34

BloodGlucoseLogSheet

Patient: _________________________________________________________________________ DOB: _____________________________

Phone:(Home)________________________________ (Work)_______________________________ /_______________________________ Time Rate

Basal Rate: 1. 12 A.M. _________

2. _________ _________

3. _________ _________

4. _________ _________

5. _________ _________

Date ______ /______ /______ 12A.M. 3A.M. Pre-Brkfst Post-Brkfst Pre-Lunch Post-Lunch Pre-Dinner Post-Dinner Bedtime

Time

Blood Glucose

Carb Grams

FoodDose

Correction Dose

Total Bolus


Time

Blood Glucose

Carb Grams

FoodDose

Correction Dose

Total Bolus


Time

Blood Glucose

Carb Grams

FoodDose

Correction Dose

Total Bolus


Time

Blood Glucose

Carb Grams

FoodDose

Correction Dose

Total Bolus


Time

Blood Glucose

Carb Grams

FoodDose

Correction Dose

Total Bolus

Notes:

Pumping ProtocolbyBruceBode,MD.©2008MedtronicMiniMed,Inc.Allrightsreserved.9402236-011042408

Meal Bolus: 1 Unit of insulin covers this many grams of carbohydrate. CarbRatio:(B)_______(L)_______(D)_______

Insulin Sensitivity Factor: 1 Unit of insulin lowers BG _______ mg/dL

(Current BG – Target) ÷ Sensitivity Factor = Correction Dose

BG Target Range: Daytime = _______mg/dL – _______mg/dL

BG Target Range: Nighttime = _______mg/dL – _______mg/dL

Faxto:______________________________________________

35

Meal Bolus: 1 Unit of insulin covers this many grams of carbohydrate. CarbRatio:(B)_______(L)_______(D)_______

Insulin Sensitivity Factor: 1 Unit of insulin lowers BG _______ mg/dL

(Current BG – Target) ÷ Sensitivity Factor = Correction Dose

BG Target Range: Daytime = _______mg/dL – _______mg/dL

BG Target Range: Nighttime = _______mg/dL – _______mg/dL

Faxto:

PumpModel: PumpSerialNumber:

Patient Name: Date:

DOB: Weight:

Current Regimen: = units

Pump Initiation SettingsPRESCRIBER’S INSTRUCTIONS TO PATIENT

Calculations for Insulin Pump Initiation Settings

Formula

Reduced Dose Injection Dose x 0 .75 = Reduced Dose

Weight(lbs.)x0.23=WeightDose

DailyCarbGrams÷TotalDailyBolus=CarbRatio

1700÷PumpTDD=InsulinSensitivityFactor

(ReducedDose+WeightDose)÷2=PumpTDD

PumpTDDx%Basal(40–50%)=TotalDailyBasal

TotalDailyBasal÷24hours=HourlyBasalRate

__________ units/day x 0 .75 = __________ units/day

__________ lbs . x 0 .23 units = __________ units/day

________grams÷_______units/day=_________grams/unit

1700÷__________units=__________mg/dL/1unit

(______units/day+_______units/day)÷2=______units/day

__________ units/day x _________ = __________ units/day

__________units÷24hours=__________units/hour

Weight Dose

Pump TDD

Total DailyBasalUnits

Initial Basal Rate

Insulin-to-Carb Ratio

Insulin Sensitivity Factor

Basal Rates

Time Rate1)_______@_______2)_______@_______3)_______@_______4)_______@_______5)_______@_______

Carb Ratio

(B)

(L)

(D)

Sensitivity Factor

ISF=_________mg/dL/1unit

Active Insulin Time___________ hours

Adults: 4-5 hoursChildren: 3-4 hoursPregnancy: 3-4 hours

Day NightAdultsandAdolescents(13+yrs): 90–100mg/dL 100–110mg/dLSchoolAge(6–12yrs): 90–110mg/dL 100–120mg/dLToddlertoPre-school(0–6yrs): 100–120mg/dL 110–130mg/dLHypoglycemiaUnawareness: 100–120mg/dL 110–130mg/dLPregnancy: 80–90mg/dL 90–90mg/dL

Bolus Wizard® Calculator Target Ranges

Day

_______—_______

Night

_______—_______

Pum

p TD

DBa

sal R

ate

ICR

ISF

Calculation

Pump Settings

Instructions for Adjustments•Ifnocturnal,fasting/pre-mealorbedtimeBG>target,increasebasal10–20%•Ifnocturnal,fasting/pre-mealorbedtimeBG<target,decreasebasal10–20%•Ifpost-mealBG>60mg/dLabovepre-mealBG,decreasecarbratioby10–20%•Ifpost-mealBG<30mg/dLabovepre-mealBG,increasecarbratioby10–20%

ElevatedBG:Verifytrends2–3daysbeforeadjustingLow BG: Consider immediate adjustment

Comments:94

0223

6-01

420

1110

03©

2011

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.Allrig

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ed.

Total Daily Injection Dose

Reduced Dose

Pump TDD

Weight Dose

Pump TDD

Reduced Dose Weight Dose

Total Daily Basal

Total Daily Bolus

Pump TDD

% Basal

Initial Basal Rate

Insulin-to-Carb Ratio

InsulinSensitivityFactor

Adjustments should be made when BGs are outside of these ranges

Fasting/pre-meal:__________to__________mg/dL

Post-meal: __________ to __________ mg/dL

Bedtime: __________ to __________ mg/dL

Nocturnal: __________ to __________ mg/dL

12 a .m .

These instructions shall be valid for 6 months unless otherwise specified here: ______________months .

Total Daily Basal

Injection Dose

Weight

Daily Carbs

450÷PumpTDD=CarbRatio 450÷_______units/day=_________grams/unitPump TDD Insulin-to-Carb Ratio

Total DailyBolusUnits Pump TDD - Total Daily Basal = Total Daily Bolus ________ units/day - ________ units/day = ________ units/day

OR OR

Pump TDD Total Daily BolusTotal Daily Basal

Prescriber Name: Signature: Date:Call MD for severe low BG or ketones. Call Medtronic for technical issues at 800-646-4633. Pumping ProtocolbyBruceBode,MD.

MaxBasalRate:______units MaxBolus:______units

36 References and Suggested Reading

References1. Hoogma RP, Hammond PJ, Gomis R, et al. Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections

(MDI) on glycaemic control and quality of life: results of the 5-nations trial. Diabet Med.2006;23:141–147.

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