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Compares treatment options for Type 2 Diabetes
Official title Insulin Pump Versus Full Closed-loop for Type 2 Diabetes
ClinicalTrials.gov ID: NCT06959797
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.