AACE2019 Senseonics House Study Abstract ePoster 120x60cm …/media/Files/S... · • Re-write your...
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Eighteen participants (15 men, mean age 40 years, mean duration of T1D 23 years) were included (Table 1). In total, 15,826 CGM/SMBG pairs were generated; 9,952 for the upper arm and 5,874 for the abdomen. The overall MARD of the system using patient-measured SMBG readings as reference was 14.9% (SD 16.4) (Table 2). 78% of the overall readings were found within the 20/20% range (Table 3). There was a sensor survival rate of 100% observed in the study, and participants wore the device 23.4 hours per day (98% of the time). The majority of the patients liked the key features of the system (Table 4) and there was an improvement in HbA1c observed during the course of the trial (Table 5). Furthermore, no device-related serious adverse events were reported during the trial. Results The Eversense CGM demonstrated robust accuracy when placed in either the abdomen or the arm in participants with T1D in a home use setting and was consistent with that reported for other CGM systems evaluated in a similar study design. The arm MARD was shown to be lower than the abdomen MARD based on the mean values. A very high mean wear-time of 98% was observed and the participants reported very high likability of the Eversense system. Discussion In a home use setting, the Eversense CGM system was demonstrated to be safe and have reliable accuracy using SMBG as reference. In this study, accuracy in the arm was better than that in the abdominal location. Conclusion HOUSE was a prospective, multi-center study conducted in two, serial 90 day sensor insertion phases in 18 participants with type 1 diabetes (T1D). In the first phase, one sensor was inserted in the upper arm and one was inserted in the abdomen. At the end of the first phase, both sensors were removed and participants chose either arm or abdomen for the next sensor insertion phase. Participants were asked to perform at least 5 SMBG measurements a day using the Contour NEXT blood glucose meter and test strips. Fingerstick measurements were used as reference to assess accuracy of the CGM system in a real-life setting. Safety and SMBG data were collected every 30 days. Methods Table 3: Accuracy within SMBG glucose ranges (combined arm and abdomen) SMBG glucose range (mg/dL) Number of paired CGM-SMBG reference readings % of CGM readings within 20/20% of reference 30/30% of reference 91 85 90 92 78 73 77 80 15,826 1,122 9,230 5,474 Overall <70 70-180 >180 Table 4: Likeability of Eversense CGM Proportion of study participants who liked: 94% 74% 75% 79% 94% Ability to display glucose readings on mobile Hypoglycemia/hyperglycemia alert detection Predicted hypoglycemia/hyperglycemia alert detection 90 day sensor duration Sensor in the arm vs. abdomen Table 5: HbA1c changes Day 180 Mean (%) Mean change (%) 6.83 -0.31 Day 90 6.85 -0.29 Screening 7.14 Table 2: Accuracy vs SMBG by Sensor Site Sensor insertion site MARD (%) Number of paired CGM-SMBG reference readings Combined (arm, abdomen) Arm Abdomen 15,826 9,952 5,874 14.9 14.0 16.3 Table 1: Patient Characteristic (n=18) Characteristic Value Age, mean (SD) Male sex, n (%) Caucasian race, n (%) Black, n (%) BMI (kg/m 2 ), mean (SD) Continuous insulin infusion pump, n (%) Multiple daily injections, n (%) Duration of diabetes (yrs), mean (SD) Prior CGM use, n (%) 40 (12) 15 (83) 17 (94) 1 (6) 25.6 (4.4) 7 (39) 11 (61) 23 (14) 16 (89) The novel long-term implantable Eversense continuous glucose monitoring system (CGM) has been demonstrated to be safe and accurate against a standard reference glucose analyzer. The effectiveness and safety of Eversense was studied in a Home use (HOUSE) setting in Sweden using SMBG readings as reference. Objective The Eversense CGM system accuracy and safety assessment on the abdomen compared to the upper arm in a home use setting Magnus Londahl, MD, PhD 1 ; Mona Landin-Olsson, MD, PhD 1 ; Stig Attvall MD, PhD 2 ; Colleen Mdingi MS 3 ; Katherine S. Tweden, PhD 3 1 Lund University, Lund, Sweden; 2 University Hospital, Gothenburg, Sweden; 3 Senseonics Inc, Germantown, MD, USA CONTACT INFORMATION Senseonics, Inc. 20451 Seneca Meadows Parkway, Germantown, MD 20876 Phone: 844-SENSE4U (736-7348) Email: [email protected]
Transcript of AACE2019 Senseonics House Study Abstract ePoster 120x60cm …/media/Files/S... · • Re-write your...
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RESULTS
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CONTACT INFORMATION Highlight this text and replace with your own text.
P o s t e r t i t l e g o e s h e r e Authors, FIRST NAME INITIAL, SURNAME, presenting author(s) underlined, Affiliations1 numbered in superscripte.g. B. SMITH 1, N. HARRISON 2 2 and P. MATTHEWS2
1University of New South Wales, Sydney, Australia2Royal Brisbane Hospital, Brisbane, Australia
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Eighteen participants (15 men, mean age 40 years, mean duration of T1D 23 years) were included (Table 1). In total, 15,826 CGM/SMBG pairs were generated; 9,952 for the upper arm and 5,874 for the abdomen. The overall MARD of the system using patient-measured SMBG readings as reference was 14.9% (SD 16.4) (Table 2). 78% of the overall readings were found within the 20/20% range (Table 3). There was a sensor survival rate of 100% observed in the study, and participants wore the device 23.4 hours per day (98% of the time). The majority of the patients liked the key features of the system (Table 4) and there was an improvement in HbA1c observed during the course of the trial (Table 5). Furthermore, no device-related serious adverse events were reported during the trial.
Results
The Eversense CGM demonstrated robust accuracy when placed in either the abdomen or the arm in participants with T1D in a home use setting and was consistent with that reported for other CGM systems evaluated in a similar study design. The arm MARD was shown to be lower than the abdomen MARD based on the mean values. A very high mean wear-time of 98% was observed and the participants reported very high likability of the Eversense system.
Discussion
In a home use setting, the Eversense CGM system was demonstrated to be safe and have reliable accuracy using SMBG as reference. In this study, accuracy in the arm was better than that in the abdominal location.
ConclusionHOUSE was a prospective, multi-center study conducted in two, serial 90 day sensor insertion phases in 18 participants with type 1 diabetes (T1D). In the first phase, one sensor was inserted in the upper arm and one was inserted in the abdomen. At the end of the first phase, both sensors were removed and participants chose either arm or abdomen for the next sensor insertion phase. Participants were asked to perform at least 5 SMBG measurements a day using the Contour NEXT blood glucose meter and test strips. Fingerstick measurements were used as reference to assess accuracy of the CGM system in a real-life setting. Safety and SMBG data were collected every 30 days.
Methods
Table 3: Accuracy within SMBG glucose ranges (combined arm and abdomen)
SMBG glucose range
(mg/dL)
Number of paired CGM-SMBG reference readings
% of CGM readings within
20/20%of reference
30/30%of reference
91859092
78737780
15,8261,122
9,2305,474
Overall<7070-180>180
Table 4: Likeability of Eversense CGM
Proportion of study participants who liked:
94%74%75%79%94%
Ability to display glucose readings on mobile Hypoglycemia/hyperglycemia alert detectionPredicted hypoglycemia/hyperglycemia alert detection90 day sensor durationSensor in the arm vs. abdomen
Table 5: HbA1c changes
Day 180
Mean (%)Mean change (%)
6.83-0.31
Day 90
6.85-0.29
Screening
7.14
Table 2: Accuracy vs SMBG by Sensor Site
Sensor insertion site MARD (%)Number of paired CGM-SMBG reference readings
Combined(arm, abdomen)ArmAbdomen
15,8269,9525,874
14.914.016.3
Table 1: Patient Characteristic (n=18)
Characteristic Value
Age, mean (SD)Male sex, n (%) Caucasian race, n (%)Black, n (%)BMI (kg/m2), mean (SD) Continuous insulin infusion pump, n (%)Multiple daily injections, n (%)Duration of diabetes (yrs), mean (SD)Prior CGM use, n (%)
40 (12)15 (83)17 (94)
1 (6)25.6 (4.4)
7 (39)11 (61)23 (14)16 (89)
The novel long-term implantable Eversense continuous glucose monitoring system (CGM) has been demonstrated to be safe and accurate against a standard reference glucose analyzer. The e�ectiveness and safety of Eversense was studied in a Home use (HOUSE) setting in Sweden using SMBG readings as reference.
Objective
The Eversense CGM system accuracy and safety assessment on the abdomen compared to the upper arm in a home use setting
Magnus Londahl, MD, PhD1; Mona Landin-Olsson, MD, PhD1; Stig Attvall MD, PhD2; Colleen Mdingi MS3; Katherine S. Tweden, PhD3
1Lund University, Lund, Sweden; 2University Hospital, Gothenburg, Sweden; 3Senseonics Inc, Germantown, MD, USA
CONTACT INFORMATION Senseonics, Inc. 20451 Seneca Meadows Parkway, Germantown, MD 20876 Phone: 844-SENSE4U (736-7348) Email: [email protected]
