Smart insulin system could ease diabetes management for type 2 patients
NCT ID NCT06959797
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a fully closed-loop insulin system (which automatically adjusts insulin delivery) works better than a standard insulin pump for people with type 2 diabetes. Eighty adults who have used an insulin pump for at least six months will try both methods for 12 weeks each. The goal is to see which approach keeps blood sugar in a healthy range more consistently and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Closed-loop automated insulin delivery system (Ypsomed pump, CamAPS HX app, Freestyle Libre 3 sensor)
- What this could lead to
- If successful, this could show that a fully automated insulin system helps people with type 2 diabetes maintain better blood sugar levels with less effort than a standard pump.
- What could go wrong
- This is a relatively small, early-stage crossover study (80 participants). The system may not work for everyone, and there are risks of hypoglycemia or device issues. Results may not apply to all type 2 diabetes patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Caen University Hospital
RECRUITINGCaen, France
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