Type 1 DiabetesHCL-VHPNCT05282264
Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Centre Hospitalier Sud Francilien at 2 sites in France.
Trial summary
While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- device
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2022to 11 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients followed in the diabetes department of the Centre Hospitalier Sud Francilien
Who may be able to join
- Patients with closed loop system :
- Adult patients
- With T1D for at least 2 years
- Follow-up in the diabetes department of the CHSF
- Having a laboratory HbA1c > 11% at least once during the past year and at least one other HbA1c > 10% in the previous 3 years
- Accepting the closed loop system as part of their support
Show all 15Show fewer
- Subject informed of the study and not objecting to it
- Patients without closed loop system :
- Adult patients
- With T1D for at least 2 years
- Follow-up in the diabetes department of the CHSF
- Having a laboratory HbA1c > 11% at least once during the past year and at least one other HbA1c > 10% in the previous 3 years
- Refusing the closed loop system as part of their support or
- Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and nurse referents of the patient) within the service leads to the evaluation of an unfavorable benefit/risk ratio
- Subject informed of the study and not objecting to it
Who cannot join
- Patients with closed loop system :
- Patients without an Internet connection, or without a smartphone or computer
- Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and patient referent nurse) within the department results in the assessment of an unfavorable benefit/risk ratio (patients with a history of interrupted pump treatment on medical decision, serious psychiatric disorders…)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Penfornis
Corbeil-Essonnes, Centre Hospitalier Sud Francilien, 91106
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
About this study
While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes.
The investigators conduct a retrospective, observational, and single-center study to evaluate the acceptability, safety, and efficacy of a CLID system in patients living with T1D (≥2 years) with a HbA1c>11% in the past 12 months and a mean HbA1c >10% over the past three years. Efficacy was assessed using continuous glucose monitoring parameters.
Read the detailed description
If hybrid closed-loop systems (HCLS) ("artificial pancreas") for automated insulin administration have demonstrated their great interest in patients living with moderately unbalanced type 1 diabetes (T1D) (HbA1c < 8 .6% on average), no study has looked at their safety, acceptability and efficacy in patients living with highly and chronically unbalanced T1D (HbA1c > 11%). These patients, often young, present more or less advanced microangiopathic complications (retinopathy, nephropathy, neuropathy, etc.) or are highly exposed to the appearance of these complications, the prevention of which, whether primary or secondary, involves obtaining a good glycemic balance over time. These patients "escape" the possibilities of current insulin therapy, whether by multiple insulin injections or by insulin pump, more or less coupled to a continuous glucose monitoring system. Automated insulin delivery systems could be a solution to achieve less catastrophic glycemic control in some of these patients. The investigators are proposing a pilot study aimed at evaluating acceptability, safety and effectiveness of a HCLS currently available in France (the SMARTGUARD™ MINIMED™ 780G or the Control-IQ) in patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien (CHSF), living with highly unbalanced T1D (HbA1c > 11%) in the context of usual follow-up.
- Conditions
- Type 1 Diabetes
- Being tested
- device
- Keywords
- Highly unbalanced Type 1 diabetes, hybrid closed loops, acceptability, efficacy and safety, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deviceOther
closed-loop insulin
| Study group | Role | What they receive |
|---|---|---|
| Patient with hybrid closed-loop systems | Not described Receives: Other: device | |
| Patient without hybrid closed-loop systems | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of hybrid closed-loop systems
Maintenance rate of a hybrid closed-loop system in patients living with highly unbalanced T1D (HbA1c > 11%) and followed in the diabetes department of the CHSF
Measured: at 12 months
Secondary outcomes (10)
Demographic characteristics : age
year
- lives alone or not; precariousness index,
- psychiatric history,
- number of hospitalizations related to diabetes, severe hypoglycaemia, ketoacidosis in the last 3 years,
- weight, body mass index (BMI),
- treatment of diabetes: pump (brand, year), multiple injections (MDI),
- complications of diabetes; microangiopathic: retinopathy (shape and stage), nephropathy (estimated glomerular filtration rate by the CKD-EPI formula, albuminuria/creatinine ratio), neuropathies; macroangiopathic
- average HbA1c level for the last 3 years
Measured: at day 0
Demographic characteristics : gender
feminine or masculine
- psychiatric history,
- number of hospitalizations related to diabetes, severe hypoglycaemia, ketoacidosis in the last 3 years,
- weight, body mass index (BMI),
- treatment of diabetes: pump (brand, year), multiple injections (MDI),
- complications of diabetes; microangiopathic: retinopathy (shape and stage), nephropathy (estimated glomerular filtration rate by the CKD-EPI formula, albuminuria/creatinine ratio), neuropathies; macroangiopathic
- average HbA1c level for the last 3 years
Measured: at day 0
Demographic characteristics : level of education
year
Measured: at day 0
Demographic characteristics : currrent activity
student, active, retired, unemployed, etc.
Measured: at day 0
Demographic characteristics : duration of diabete
year
Measured: at day 0
HbA1c
HbA1c
Measured: at day 0
Efficiency
- If the patient has interrupted the treatment with hybrid closed-loop, reason for the discontinuation,
- % of time spent under HCLS,
- Change of pump between M0 and M12 (Yes/no).
- Change of transmitter between M0 and M12 (Yes/no),
- Average total insulin dose per day,
- Basal/Bolus ratio,
- Amount of carbohydrates entered/day,
- Target objective (mg/dL) set,
- Number of sensors consumed
- Number of sensor malfunctions
- International consensus criteria on the interpretation of continuous glucose monitoring (CGM):
- Evolution of the time spent in the target (TIR),
- Change in time above target (TAR) for hyperglycaemia > 250 mg/dL, from 181 to 250 mg/dL,
- Evolution of the time spent below the target of 54 to 69 mg/dL and < 54 mg/dL,
- Evolution of the glycemic average,
- Evolution of the coefficient of variation (CV).
Measured: At baseline, 3, 6, and 12 months
Quality
Questionnaire Diabetes Quality of life : from 1 ( very satisfaying) to 5 (very unsatisfactory)
Measured: At baseline, 3, 6, and 12 months
Patient satisfaction
Questionnaire Diabetes Quality of life : from 3 (many) to -3 (less)
Measured: At baseline, 3, 6, and 12 months
Hypoglycemia Fear
Hypoglycemia Fear Survey : from 0 (never) to 4 (almost always)
Measured: At baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Apr 2022
- Primary completion15 Jul 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282264
- Sponsor's protocol ID
- 2022-A00144-39
- Acronym
- HCL-VHP
- Status last verified
- May 2026
- First submitted
- 4 Feb 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deepchand S, Balla V, Eroukhmanoff J, Ly Sall K, Romain B, Lejeune M, Penfornis A, Amadou C. Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe! Diabetes Technol Ther. 2024 Feb;26(2):125-129. doi: 10.1089/dia.2023.0379. Epub 2024 Jan 11.
PubMed 37955849
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Hybrid Closed-loop Systems in Patients Living With Highly Unbalanced Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05282264
- Acronym / sponsor ID
- HCL-VHP / 2022-A00144-39
- Conditions
- Type 1 Diabetes
- Keywords
- Highly unbalanced Type 1 diabetes, hybrid closed loops, acceptability, efficacy and safety, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 16 Mar 2022 (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.
While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes.
The investigators conduct a retrospective, observational, and single-center study to evaluate the acceptability, safety, and efficacy of a CLID system in patients living with T1D (≥2 years) with a HbA1c>11% in the past 12 months and a mean HbA1c >10% over the past three years. Efficacy was assessed using continuous glucose monitoring parameters.
Detailed description
If hybrid closed-loop systems (HCLS) ("artificial pancreas") for automated insulin administration have demonstrated their great interest in patients living with moderately unbalanced type 1 diabetes (T1D) (HbA1c < 8 .6% on average), no study has looked at their safety, acceptability and efficacy in patients living with highly and chronically unbalanced T1D (HbA1c > 11%). These patients, often young, present more or less advanced microangiopathic complications (retinopathy, nephropathy, neuropathy, etc.) or are highly exposed to the appearance of these complications, the prevention of which, whether primary or secondary, involves obtaining a good glycemic balance over time. These patients "escape" the possibilities of current insulin therapy, whether by multiple insulin injections or by insulin pump, more or less coupled to a continuous glucose monitoring system. Automated insulin delivery systems could be a solution to achieve less catastrophic glycemic control in some of these patients. The investigators are proposing a pilot study aimed at evaluating acceptability, safety and effectiveness of a HCLS currently available in France (the SMARTGUARD™ MINIMED™ 780G or the Control-IQ) in patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien (CHSF), living with highly unbalanced T1D (HbA1c > 11%) in the context of usual follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with hybrid closed-loop systems | – | Other: device |
| Patient without hybrid closed-loop systems | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in the diabetes department of the Centre Hospitalier Sud Francilien
Key inclusion criteria (15 listed)
- Adult patients
- With T1D for at least 2 years
- Follow-up in the diabetes department of the CHSF
- Having a laboratory HbA1c > 11% at least once during the past year and at least one other HbA1c > 10% in the previous 3 years
- Accepting the closed loop system as part of their support
Key exclusion criteria (3 listed)
- Patients without an Internet connection, or without a smartphone or computer
- Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and patient referent nurse) within the department results in the assessment of an unfavorable benefit/risk ratio (patients with a history of interrupted pump treatment on medical decision, serious psychiatric disorders…)
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 |
|---|---|---|
| deviceclosed-loop insulin | Other | Patient with hybrid closed-loop systems |
Primary outcome
Acceptability of hybrid closed-loop systems
Time frame: at 12 months
Maintenance rate of a hybrid closed-loop system in patients living with highly unbalanced T1D (HbA1c > 11%) and followed in the diabetes department of the CHSF
10 secondary outcomes
Demographic characteristics : age
Time frame: at day 0
Demographic characteristics : gender
Time frame: at day 0
Demographic characteristics : level of education
Time frame: at day 0
Demographic characteristics : currrent activity
Time frame: at day 0
Demographic characteristics : duration of diabete
Time frame: at day 0
HbA1c
Time frame: at day 0
Efficiency
Time frame: At baseline, 3, 6, and 12 months
Quality
Time frame: At baseline, 3, 6, and 12 months
Patient satisfaction
Time frame: At baseline, 3, 6, and 12 months
Hypoglycemia Fear
Time frame: At baseline, 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 37955849Deepchand S, Balla V, Eroukhmanoff J, Ly Sall K, Romain B, Lejeune M, Penfornis A, Amadou C. Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe! Diabetes Technol Ther. 2024 Feb;26(2):125-129. doi: 10.1089/dia.2023.0379. Epub 2024 Jan 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Centre Hospitalier Sud Francilien at 2 sites 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 15 inclusion and 3 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of hybrid closed-loop systems (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05282264, which also lists 1 linked publication.
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 22 May 2026.