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Insulin Pump Versus Full Closed-loop for Type 2 Diabetes

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Caen
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In plain words

What the trial is, and whether it could suit you

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 1รจre sequence, all p

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • Closed loop
  • Open loop
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Where

1 site
Caen University Hospital
Caen, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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