The purpose of this study evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) system in sub-optimally controlled patients with T1D, in comparison with Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM). Patient with a diagnosis of Type 1 diabetes currently under MDI+ FGM or MDI+ CGM therapy will be enrolled.
This study is a pre-market, multi-center, prospective, open label, adaptative, randomized controlled trial in insulin-requiring adult subjects with type 1 diabetes on MDI therapy. The study will have three period: 1. Run-in Phase: The Run-in period is of 4 weeks (and can be extended for 2 additional ones) during which time a blinded CGM sensor will be worn for two weeks. 2. Study Phase: There will be a 6 months randomized study period with two arms: Treatment Arm (AHCL) and the Control Arm. 3. Continuation Phase: There will be a 6 months continuation phase during which time all the subjects will use the AHCL system. Approximately 124 subjects will be enrolled in the study up to 20 investigational centers in EMEA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM
Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0. Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment.
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besançon, France
CHU de Bordeaux - Hôpital Saint André
Bordeaux, France
CHU Caen
Caen, France
HbA1c 6 Months Change Between AHCL and MDI
The difference in the mean HbA1c change (6 months - baseline) between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).
Time frame: Baseline and end of 6-month study phase
TIR Between 70-180 mg/dL
% Time spent within range with sensor glucose (SG) between 70 - 180 mg/dL (3.9-10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).
Time frame: 6 months study phase
Time in Hyperglycemic Range
% Time spent in hyperglycemic range with SG \> 180 mg/dL (\> 10.0 mmol/L). The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A).
Time frame: 6 months study phase
Hypoglycemic Events
Number of biochemical hypoglycemic events\< 54 mg/dL (3.0 mmol/L) (defined as sensor values \< 54 mg/dL (3.0 mmol/L) per 15 consecutive minutes (Danne, 2017). When the time between two successive events is less than 30 minutes, they will be combined and counted as one event. The difference in the mean between the AHCL and the MDI + FGM arm will be evaluated (Cohort A)
Time frame: 6 months study phase
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Hospices Civils de Lyon (DIAB-e CARE)
Lyon, France
APM - Hôpital de la Conception
Marseille, France
Hospital Civil
Strasbourg, France
Diabetologische Schwerpunktpraxis Dr. Ralf Kolassa
Bergheim, Germany
Zentrum für Diabetologie Bergedorf
Hamburg, Germany
Gemeinschaftspraxis im Westtor Hausarztpraxis & Diabetologische Schwerpunktpraxis
Lage, Germany
Medical Center am Clemenshospital Dr. Winfried Keuthage
Münster, Germany
...and 4 more locations