Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)

NCT05369871 | Completed

• 1 other identifier: RCB 2020-A03429-30
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with type 2 diabetes (T2D) treated with insulin pumps.

Conditions

Diabetes Mellitus Type 2 - Insulin-Treated

Outcome Measures

Primary Outcomes (1)

• Glycemic control evaluation for the 12-week main study

  Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the glycemic balance (time spent in the target 70-180 mg/dL). The data used for the analysis are the last 4 weeks of each 6-week sequence.

  Day 84

Secondary Outcomes (21)

• Daily glycemic variability evaluation for the 12-week main study

  Day 84

• Daily glycemic variability evaluation for the 12-week main study

  Day 84

• Daily time spent in hypoglycemia evaluation for the 12-week main study

  Day 84

• Daily time spent in hyperglycemia evaluation for the 12-week main study

  Day 84

• Daily amount of insulin administered evaluation for the 12-week main study

  Day 84

Study Arms (2)

Closed-loop system followed by open-loop system

EXPERIMENTAL

An interventional cross-over study: * six weeks in closed-loop system with Accu-Chek Insight pump and continuous glucose monitoring (CGM) :consisting of 2 weeks of adaptation where data will not be collected + 4 weeks * followed by six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks , Followed by an optional additional study: 4 weeks in closed-loop system.

Device: Closed-loop system; Device: Open-loop system

Open-loop system followed by closed-loop system

EXPERIMENTAL

An interventional cross-over study: * six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks * followed by six weeks in closed-loop system with Accu-Chek Insight pump and CGM (including two weeks of adaptation) : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks Followed by an optional additional study: 4 weeks in closed-loop system.

Device: Closed-loop system; Device: Open-loop system

Interventions

Closed-loop system DEVICE

Closed-loop system consisting of a terminal including the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the Accu-Chek Insight insulin pump.

Closed-loop system followed by open-loop system; Open-loop system followed by closed-loop system

Open-loop system DEVICE

Open-loop system consisting of a terminal without the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the usual insulin pump.

Closed-loop system followed by open-loop system; Open-loop system followed by closed-loop system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient \> 18 years old
• Patient with a weight \< 150 kg
• Patient with type 2 diabetes (T2D) treated by insulin pump for at least 6 months
• Patient with stable pharmacological treatment of diabetes for at least 6 months
• Patient equipped with a CGM or Flash Glucose Meter (FGM)
• Patient diagnosed with T2D by a diabetologist
• Patient treated with a total daily dose of insulin \< 160 U/24 h
• Patient with an HbA1c \< 10%.
• Patient affiliated to the social security system or beneficiary of such a system
• Patient able to read and understand the procedure, and in a condition to express consent for the study protocol
• Patient with type 1 diabetes
• Patient receiving less than 8 units of insulin per day
• Patients suffering from a serious illness or undergoing treatment that may affect the physiology of diabetes, i.e., interactions with glucose and/or insulin that may interfere with the medical device (e.g., steroid treatment)
• Patient with severe uncorrected hearing and/or visual acuity problems
• Patient not wishing to use rapid-acting insulin analog 100 U/mL

Sponsors & Collaborators

• Diabeloop: lead
• Icadom: collaborator
• AGIR à Dom: collaborator
• University Hospital, Grenoble: collaborator
• Centre Hospitalier Annecy Genevois: collaborator
• Centre Hospitalier Metropole Savoie: collaborator

Study Sites (3)

CH Métropole Savoie

Chambéry, 73300, France

Location

CH Annecy-Genevois

Epagny Metz-Tessy, 74374, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Study Officials

• Anne-Laure BOREL, MD, PhD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: August 29, 2022
• Primary Completion: May 9, 2023
• Study Completion: July 28, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)