Type 2 DiabetesIA-DT2NCT06959797
Insulin Pump Versus Full Closed-loop for Type 2 Diabetes
A study testing Closed loop and Open loop in people with Type 2 Diabetes, run by University Hospital, Caen at 1 site in France.
Trial 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, on the efficacy and safety of use of the Fully Closed Loop, as well as on psycho-social criteria of device… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Closed loop and Open loop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
Yves REZNIK, MD PhD, 0231065781, drci-secretariat@chu-caen.fr
About this study
Official title: Randomized Cross-over Study Comparing Insulin Pump Versus Full Closed-loop Automated Insulin Therapy in Type 2 Diabetic Patients Previously Treated With Insulin Pumps
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 1ère sequence, all patients will undergo a 2-4 week washout, during which they will use the Ypsomed pump and the FreeStyle Libre 3 sensor in open loop, and then in the 2nd sequence of the study, patients will switch to the other treatment for a further 12 weeks. A total of 80 patients on insulin pumps for at least 6 months will be recruited from 9 French centers. All patients will receive training in the use of the Ypsomed pump, the FreeStyle Libre 3 sensor and the CamAPS HX algorithm. The primary objective is Time on Target 70-180 mg/dl of 24h measured during the 12 weeks of each therapeutic period. Secondary objectives will be Time in Target 70-180 mg/dl day and night, Time above Target > 180 mg/dl and > 250 mg/dl, Time below Target < 70 mg/dl and < 54 mg/dl, time in the narrow target range 70-140 mg/dL, mean 24h blood glucose and glycemic variability measured over the 12 weeks of each treatment sequence, HbA1c, weight, total insulin dose and psychosocial endpoints assessed at the start and end of each treatment sequence. Safety data studied will include diabetes-related adverse events (ketoacidosis, symptomatic and severe hypoglycemia) and medical device-related adverse events (pump and sensor).
- Conditions
- Type 2 Diabetes
- Being tested
- Closed loop, Open loop
- Keywords
- Type 2 diabetes, automated insulin therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loopDevice
Ypsomed pump (Ypsomed), CamAPS HX application activated, Android smartphone. Freestyle 3 sensors (Abbott)
Open loopDevice
Ypsomed pump (Ypsomed). Android smartphone. Freestyle 3 sensors (Abbott)
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Closed loop then Open loop) | Experimental | Ypsomed pump (Ypsomed), CamAPS HX application activated, Android smartphone. Freestyle 3 sensors (Abbott) Then Ypsomed pump (Ypsomed). Android smartphone. Freestyle 3 sensors (Abbott) Receives: Device: Closed loop; Device: Open loop |
| Arm II (Loop Open then Loop Closed) | Experimental | Ypsomed pump (Ypsomed). Android smartphone. Freestyle 3 sensors (Abbott) Then Ypsomed pump (Ypsomed), CamAPS HX application activated, Android smartphone. Freestyle 3 sensors (Abbott) Receives: Device: Closed loop; Device: Open loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time on target [70-180] mg/dl over 24h for the 12 weeks of each treatment sequence
Time on target [70-180] mg/dl over 24h for the 12 weeks of each treatment sequence
Measured: from baseline for the 12 weeks of each treatment sequence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start5 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical Investigation of a Medical Device (IC-DM)
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, mylife Diabetes Care AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959797
- Sponsor's protocol ID
- 23-0251
- Other IDs
- ID RCB 2023-A02593-42
- Acronym
- IA-DT2
- Status last verified
- May 2026
- First submitted
- 24 Apr 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Study Comparing Insulin Pump Versus Full Closed-loop Automated Insulin Therapy in Type 2 Diabetic Patients Previously Treated With Insulin Pumps
- ClinicalTrials.gov ID
- NCT06959797
- Acronym / sponsor ID
- IA-DT2 / 23-0251
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, automated insulin therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Abbott, mylife Diabetes Care AG
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1ère sequence, all patients will undergo a 2-4 week washout, during which they will use the Ypsomed pump and the FreeStyle Libre 3 sensor in open loop, and then in the 2nd sequence of the study, patients will switch to the other treatment for a further 12 weeks. A total of 80 patients on insulin pumps for at least 6 months will be recruited from 9 French centers. All patients will receive training in the use of the Ypsomed pump, the FreeStyle Libre 3 sensor and the CamAPS HX algorithm. The primary objective is Time on Target 70-180 mg/dl of 24h measured during the 12 weeks of each therapeutic period. Secondary objectives will be Time in Target 70-180 mg/dl day and night, Time above Target > 180 mg/dl and > 250 mg/dl, Time below Target < 70 mg/dl and < 54 mg/dl, time in the narrow target range 70-140 mg/dL, mean 24h blood glucose and glycemic variability measured over the 12 weeks of each treatment sequence, HbA1c, weight, total insulin dose and psychosocial endpoints assessed at the start and end of each treatment sequence. Safety data studied will include diabetes-related adverse events (ketoacidosis, symptomatic and severe hypoglycemia) and medical device-related adverse events (pump and sensor).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical Investigation of a Medical Device (IC-DM)
| Arm | Type | Receives |
|---|---|---|
| Arm I (Closed loop then Open loop) | Experimental | Device: Closed loop, Device: Open loopYpsomed pump (Ypsomed), CamAPS HX application activated, Android smartphone. Freestyle 3 sensors (Abbott) Then Ypsomed pump (Ypsomed). Android smartphone. Freestyle 3 sensors (Abbott) |
| Arm II (Loop Open then Loop Closed) | Experimental | Device: Closed loop, Device: Open loopYpsomed pump (Ypsomed). Android smartphone. Freestyle 3 sensors (Abbott) Then Ypsomed pump (Ypsomed), CamAPS HX application activated, Android smartphone. Freestyle 3 sensors (Abbott) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed loopYpsomed pump (Ypsomed), CamAPS HX application activated, Android smartphone. Freestyle 3 sensors (Abbott) | Device | Arm I (Closed loop then Open loop), Arm II (Loop Open then Loop Closed) |
| Open loopYpsomed pump (Ypsomed). Android smartphone. Freestyle 3 sensors (Abbott) | Device | Arm I (Closed loop then Open loop), Arm II (Loop Open then Loop Closed) |
Primary outcome
Time on target [70-180] mg/dl over 24h for the 12 weeks of each treatment sequence
Time frame: from baseline for the 12 weeks of each treatment sequence
Time on target [70-180] mg/dl over 24h for the 12 weeks of each treatment sequence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed loop and Open loop in people with Type 2 Diabetes, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time on target [70-180] mg/dl over 24h for the 12 weeks of each treatment sequence (time frame: from baseline for the 12 weeks of each treatment sequence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.