Status:
NOT_YET_RECRUITING
Insulin Pump Versus Full Closed-loop for Type 2 Diabetes
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Abbott
mylife Diabetes Care AG
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06959797
Start Date
May 5 2025
End Date
December 31 2028
Last Update
May 7 2025
Active Locations (1)
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1
Caen University Hospital
Caen, France