Ohad Cohen, Switzerland

Medtronic International Trading Sarl Health Economics

Presenter Of 6 Presentations

The MiniMed™ 670G System

Session Name
Session Type
INDUSTRY SESSION
Date
19.02.2020, Wednesday
Session Time
16:15 - 17:45
Channel
Paris
Lecture Time
16:15 - 16:30

REAL-LIFE USE AND PERFORMANCE OF THE MINIMEDTM 670G SYSTEM IN EUROPE

Session Name
ARTIFICIAL PANCREAS
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:36 - 09:37

Abstract

Background and Aims

Auto Mode use during the MiniMedTM 670G system clinical trials, in patients with type 1 diabetes (T1D) aged ≥7 years, demonstrated improved glycated hemoglobin levels and time spent in the target glucose range of 70-180 mg/dL (TIR), compared to Manual Mode (sensor-augmented pump therapy).1,2 Following the introduction of the system in Europe on October 2018, a performance assessment of real-life MiniMed™ 670G system use was conducted.

Methods

Data uploaded voluntarily to CareLinkTM Personal software from 01 October 2018 to 14 August 2019 by individuals living in Europe, who provided consent for their data to be aggregated, were analyzed. The percentage of time spent in the various glycemic ranges, mean sensor glucose (SG) levels, and the associated Glucose Management Indicator (GMI, the calculated estimate of HbA1c) were assessed when Auto Mode was turned OFF and when Auto Mode was turned ON.

Results

Data from 4’959 individuals living in 10 different countries were included in the analysis. When the Auto Mode feature was turned ON (4’369 individuals), mean SG was 151 mg/dL, corresponding to a GMI of 6.9%. The TIR was 73.1%, time spent <70 mg/dL was 2.3%, and time spent >180 mg/dL was 24.7%. Time spent at <54 mg/dL was 0.6%, representing less than10 minutes per day. These outcomes were similar for each of the countries.

Conclusions

European individuals using the MiniMed™ 670G system with the Auto Mode feature turned ON achieved internationally-recommended goals of glycemic control with TIR >70% and a GMI of <7%, while minimizing hypoglycemia.

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RANDOMIZED TRIAL OF INFUSION SET WEAR DURATION: H-CAP EXTENDED WEAR SET VS. A CONTROL INFUSION SET

Session Name
E-POSTER DISCUSSION 06
Session Type
E-POSTER DISCUSSION
Date
20.02.2020, Thursday
Session Time
10:05 - 10:25
Channel
Station 6 (E-Poster Area)
Lecture Time
10:15 - 10:20

Abstract

Background and Aims

This study was intended to test if a new fluid path design (H-Cap Connector) could extend the infusion set wear time. Both H-Cap extended wear set (HEWS) and control infusion set MiniMed™ Quick-set™(QS, a 3-day set worn upto 7-days in this study) were compared for percent of sets reaching 7-day use without set failure for insulin pump therapy in type 1 diabetes mellitus.

Methods

Forty subjects were recruited with a target of 20 subjects completing the study. This was a randomized, open-labeled, crossover study, with each subject being asked to wear 4 HEWS and 4 regular QS infusion sets (both from Medtronic MiniMed, Northridge, CA) until the infusion set failed or 7-day use was reached.

Results

Four subjects did not participate beyond randomization during the study. One subject withdrew after 4 wears. There were 144 wears of H-Cap extended wear set and 140 wears of QS. When an infusion set was successfully used for 7 days, there was no increase in hyperglycemia or daily insulin requirements. After 7 days, the failure rate was 50.7% for QS and 30.6% for HEWS.

Conclusions

Clinical data obtained from this prospective, randomized, controlled, one site study demonstrates significant higher 7-day survival of the HEWS in comparison to regular Quick-set in this study or in previously reported study on QS in Patel et. al. study [1]. 69.4% of the HEWS used, survived 7 days.

[1] Patel PJ, Benasi K, Ferrari G, et al. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014; 16:15-19.

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Real Life Performance of the MiniMed™ 670G System

Session Type
INDUSTRY SESSION
Date
20.02.2020, Thursday
Session Time
10:30 - 12:00
Channel
Auditorium A
Lecture Time
10:50 - 11:10

The MiniMed™ 670G System

Session Type
INDUSTRY SESSION
Date
20.02.2020, Thursday
Session Time
13:00 - 14:30
Channel
Paris
Lecture Time
13:00 - 13:15

CLINICAL STUDY OF A NEW EXTENDED WEAR INFUSION SET DESIGN

Session Type
ORAL PRESENTATION SESSION
Date
21.02.2020, Friday
Session Time
09:00 - 10:00
Channel
La Paz
Lecture Time
09:20 - 09:30

Abstract

Background and Aims

In the previous studies, we reported that using a new fluid path design, H-Cap extended wear infusion set (HEWS or EWIS Gen1), extended the infusion set wear time for continuous subcutaneous insulin delivery (CSII) for patients with insulin requiring diabetes. In this study, a newly designed Extended Wear Infusion Set (EWIS Gen2) was evaluated for safety and efficacy for up to 7 days of CSII.

Methods

Twenty-six subjects were recruited with a target of 20 subjects (4 EWIS Gen2 each, until 7-day wear) completing the 1-center, prospective, open label one arm study .

Results

Twenty-one subjects participated in the study with 20 completed, resulting in 82 insertions and 78 wears. After 7 days, the failure rate, including insertion failures, was 19.5% for the EWIS, compared to 50.7% for the Quick-set™ (control) and 30.6% for the HEWS in the previous study, and 64% for Quick-set™ as reported in Patel[1] et al study. When a EWIS was successfully used for 7 days, there was no increase in hyperglycemia or daily insulin requirements.

[1] Patel PJ, Benasi K, Ferrari G, et al. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014; 16:15-19.

Conclusions

Clinical data obtained from this one arm study confirmed the new fluid path function for extending infusion set wear time. The new EWIS design provided greater than 80.5% survival when worn for 7 days (85% excluding insertion failure), which was a statistically significant improvement when compared to survival curves of a 3-day set worn for 7-days.

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