Insulin Pump vs Fully Closed-Loop for Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this open, multi-center, randomized crossover trial, adults with type 2 diabetes will compare open-loop insulin pump therapy to a fully closed-loop system using the CamAPS HX algorithm with a Ypsomed pump and FreeStyle Libre 3 sensor. Participants will undergo a run-in, then experience a 12-week sequence of open-loop therapy and a 12-week sequence of closed-loop therapy, followed by a washout period. Outcomes include efficacy, safety, and psychosocial factors such as device acceptability, quality of life, and diabetes burden. The study is based on prior work from Cambridge and uses standard insulin-pump management with automated insulin delivery in the closed-loop phase.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18
* Type 2 diabetes for at least 12 months
* On insulin pump for at least 6 months, without/with adjuvant treatment exclusively with GLP1-Ra, iSGLT2, metformin for at least 3 months
* Autonomy in the management of the pump and the glucose sensor
* HbA1c ≥ 7.5% and \< 12
* Participant's agreement to wear and use the Ypsomed with the CamAPS HX algorithm and Free Style Libre 3 sensor, and to honor the study visit schedule
* For women of childbearing age, effective contraception is required (estrogen-progestin pill, IUD, implant).

Exclusion Criteria:

* Type 1 diabetes or monogenic diabetes
* Use of U500 or U200 insulin concentrate in the pump in the last 3 months
* Allergy to insulin or to the adhesives used
* Severe insulin resistance defined by a daily insulin requirement of more than 1.5 U/kg
* History of severe hypoglycemia \> 1 time in the last 6 months.
* Current or planned use of steroids (oral, injectable) or any treatment likely to have an impact on blood glucose levels within the last 30 days.
* Current or planned pregnancy, breastfeeding
* Severe renal failure defined as GFR \< 30 ml/mn
* Proliferative retinopathy or severe maculopathy with risk of worsening during the study
* Vision or hearing problems that could compromise safe use of the device
* Acute vascular event within the last 3 months
* No autonomy for pump treatment
* Alcohol or substance abuse
* Legal protection (guardianship, curatorship)
* Any somatic or psychological condition compromising participation in the study
* Participation in another clinical trial

Where it's running

• Caen University Hospital
  Caen, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.