ADAPT
Research type
Research Study
Full title
ADAPT - ADvanced Hybrid Closed Loop study in Adult Population with Type 1 Diabetes
IRAS ID
271207
Contact name
Pratik Choudhary
Contact email
Sponsor organisation
Medtronic International Trading Sàrl
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
Research Summary
This study is a pre-market, multi-center, prospective, open label, adaptive, randomized controlled trial in insulin-requiring adult subjects with type 1 diabetes on MDI therapy. The purpose of the study is to evaluate the safety and efficacy of the Advanced Hybrid Closed Loop (AHCL) in comparison with sub-optimally controlled patients on Multiple Daily Injection (MDI) therapy with Flash Glucose Monitoring (FGM) or Real-Time Continuous Glucose Monitoring (CGM).
The study consists of a run-in phase, a study phase and a continuation phase. The purpose of the run-in phase is to collect CGM baseline data while subjects are on their current therapy. During the 6-month study phase, subjects will be randomized to continue with their current therapy or to start using the AHCL system. For the duration of the 6-month continuation phase, all enrolled subjects will be using the AHCL system.
A total of approximately 124 subjects will be enrolled in the study at up to 20 investigational centres in EMEA.
Summary of results
The results confirmed the safety and effectiveness of Advanced Hybrid Closed Loop (AHCL) therapy in sub-optimally controlled patients with Type 1 Diabetes (T1D) and show that use of AHCL therapy was associated with better glucose control in comparison to on multiple daily injection (MDI) with Flash Glucose Monitoring (FGM) .
At 6 months (primary endpoint) the decrease in glycosylated hemoglobin (HbA1c) was 1.4% greater in the AHCL arm versus the control MDI + FGM (P<0.001) with no difference in hypoglycemia. The decrease in the time spent above range (250 mg/dL and 180 mg/dL [13.9 mmol/L and 10.0 mmol/L]) was also greater in the AHCL arm (-16.87% and -27.86%, respectively). The time spent within glucose range between 70-180 mg/dL (3.9-10.0 mmol/L) was greater in the AHCL arm (70.6%) in comparison to the MDI + FGM arm (43.6%). No significant difference was observed in the percentage of time spent below 70 mg/dL and 54 mg/dL (3.9 mmol/L and 3.0 mmol/L). There were no reports of unanticipated serious adverse device effects (
USADEs) or diabetic ketoacidosis (DKAs) through the end of the study phase. Of the 3 Serious adverse event (SAEs) and 2 severe hyperglycemic events reported, none were device related.The results of Continuation Phase show that in the MDI+FGM group (control group), HbA1c was significantly decreased at 12 months by a mean of 1.4% (95% CI: -1.7 to -1.1; p<0.001) compared to at 6 months, from 8.9 (0.8)% to 7.5 (0.6%). In the AHCL group (treatment group), mean HbA1c increased by 0.1% (CI: -0.05 to 0.25) from 7.3% (0.6)% at 6 months to 7.4 (0.8)% at 12 months, meeting the non-inferiority criteria (+0.3%). The time spent in range significantly increased by 28.1% (CI:22.8 to 33.4; p<0.001) in the MDI+FGM group when switching to AHCL system, from 6 to 12 months, whereas time in hyperglycemia (above 180 mg/dL) significantly decreased (-27.2% [CI: -32.9 to 21.6]; p<0.001). In the MDI+FGM group, time in hypoglycemia (below 70 mg/dL) was unchanged from 6 to 12 months, meeting non-inferiority (-0.5% [CI: -1.5 to 0.1]). From 6 to 12 months, mean sensor glucose and standard deviation of sensor glucose both significantly decreased in the MDI+FGM group (p<0.001). In the AHCL group, all glycemic control endpoints met non-inferiority criteria for changes from 6 to 12 months of the continued use of the AHCL system. There were no reports of USADEs and DKAs through the end of the continuation phase. Of the 3 severe hypoglycemic events reported, two of which were SAEs and none were device related.
In summary, the results from the continuation phase reinforce results found in the study phase of the glucose control benefits of the AHCL system over MDI+FGM and demonstrate the sustained efficacy of the AHCL system after 12 months of use.
REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/1633
Date of REC Opinion
1 Jan 2020
REC opinion
Further Information Favourable Opinion