NCT06959797: IA-DT2

Insulin Pump Versus Full Closed-loop for Type 2 Diabetes

Not yet recruiting NA Last updated 7 May 2025

What this trial tests

NA trial testing Closed loop in Type 2 Diabetes in 80 participants. Not yet recruiting.

Timeline

5 May 2025

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	University Hospital, Caen
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	5 May 2025
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	1 location across France

Drugs / interventions tested

• Closed loop
• Open loop — full drug profile →

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

University Hospital, Caen

Who can join

18 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to compare, in a population of patients with type 2 diabetes, open-loop insulin pump treatment with the CamAPS HX (Camdiab) Fully Closed Loop Automated Insulin Therapy system, on the efficacy and safety of use of the Fully Closed Loop, as well as on psycho-social criteria of device acceptability, quality of life and diabetes burden. This is an open, multi-center, randomized, cross-over study, based on several observational or controlled trials carried out in Cambridge by Prof. Hovorka's team (see paragraph 4 below). The study will comprise a run-in phase followed by a 1st sequence in which randomized patients will use the Ypsomed pump (Ypsomed) and the FreeStyle Libre 3 sensor in open loop for 12 weeks Versus the Ypsomed pump (Ypsomed) coupled with the CamAPS HX algorithm and the FreeStyle Libre 3 sensor in full closed loop. At the end of this 1ère sequence, all patients will undergo a 2-4 week washout, during which they will use the Ypsomed pump and the FreeStyle Libre 3 sensor in open loop, and then in the 2nd sequence of the study, patients will switch to the other treatment for a further 12 weeks. A total of 80 patients on insulin pumps for at least 6 months will be recruited from 9 French centers. All patients will receive training in the use of the Ypsomed pump, the FreeStyle Libre 3 sensor and the CamAPS HX algorithm. The primary objective is Time on Target 70-180 mg/dl of 24h measured during the 12 weeks of each therapeutic period. Secondary objectives will be Time in Target 70-180 mg/dl day and night, Time above Target \> 180 mg/dl and \> 250 mg/dl, Time below Target \< 70 mg/dl and \< 54 mg/dl, time in the narrow target range 70-140 mg/dL, mean 24h blood glucose and glycemic variability measured over the 12 weeks of each treatment sequence, HbA1c, weight, total insulin dose and psychosocial endpoints assessed at the start and end of each treatment sequence. Safety data studied will include diabetes-related adverse events (ketoacidosis, symptomatic and severe hypoglycemia) and medical device-related adverse events (pump and sensor).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.