Type1 DiabetesBFHadoNCT06253351
Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes
An observational study of Type1 Diabetes and Adolescents, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Type1 Diabetes, Adolescents, Young Adults
- What is being tested?
- Hybrid closed loop (HCL)
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2024to 6 May 2024
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Tertiary care center from Centre Hospitalier Sud Francilien
Who may be able to join
- Patient aged between 15 and 25 years old
- Type 1 diabetes since at least 1 year at the moment of instauring HCL
- At least 3 months of HCL use
Who cannot join
- Informed patient that have been opposed for their data collect
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.
Read the detailed description
Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.
For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.
Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.
At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.
- Conditions
- Type1 Diabetes, Adolescents, Young Adults
- Being tested
- Hybrid closed loop (HCL)
- Keywords
- type 1 diabetes, hybrid closed-loop, adolescents, young adults, HbA1c, TIR
- 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.
Hybrid closed loop (HCL)Device
- Control IQ : T-Slim pump with Dexcom G6
- Smartguard : Medtronic 780G pump with Guardian G4S
- Diabeloop : Kaliedo pump with Dexcom G6
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop Receives: Device: Hybrid closed loop (HCL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c after HCL
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Measured: at 3 months
Secondary outcomes (11)
HbA1c after HCL
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Measured: at 6 months
HbA1c after HCL
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Measured: at 12 months
HbA1c after HCL
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
Measured: at 24 months
Use of HCL
Percentage of use of HCL
Measured: at 3 months
HCL stop
number of HCL stop
Measured: at 3 months
Glycemic parameters with CGM
pourcentage time In Range (TIR) 70-180 mg/dl
Measured: at 3 months
Glycemic parameters with CGM
pourcentage time Below Range (TBR) < 70 mg/dl
Measured: at 3 months
Glycemic parameters with CGM
pourcentage Coefficient of Variation (CV)
Measured: at 3 months
keto-acidosis and severe hypoglycemia
Comparision of keto-acidose and severe hypoglycemia events the year before HCL and after HCL
Measured: at 3 months
retinopathy
Comparison of retinography results before HCL and after HCL
Measured: at 3 months
nephropathy
Comparison microalbuminuria/creatininuria dosage the year before HCL and after HCL
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start13 Mar 2024
- Primary completion6 May 2024
- Study completion6 May 2024
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 Type1 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
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette EROUKHMANOFF, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253351
- Sponsor's protocol ID
- 2023/0060
- Acronym
- BFHado
- Status last verified
- Nov 2024
- First submitted
- 2 Feb 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ung M, Penfornis A, Valentim C, Franc S, Amadou C, Eroukhmanoff J. Hybrid Closed Loop in Adolescents and Young Adults Living with Type 1 Diabetes: A Real-World Study. Diabetes Technol Ther. 2025 Sep;27(9):760-764. doi: 10.1089/dia.2024.0528. Epub 2025 Apr 10.
PubMed 40208827
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Use of Hybrid Closed Loop in Adolescents and Young Adults 15-25 Years of Age with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06253351
- Acronym / sponsor ID
- BFHado / 2023/0060
- Conditions
- Type1 Diabetes, Adolescents, Young Adults
- Keywords
- type 1 diabetes, hybrid closed-loop, adolescents, young adults, HbA1c, TIR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 12 Feb 2024 (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 purpose of this study is to determine the effect of hybrid closed loop on glycemic outcomes in young patients aged between 15 and 25 years old with type 1 diabetes, whatever is their initial metabolic control.
Detailed description
Type 1 diabetes (T1D) constitutes a major public health challenge due to acute complications requiring emergency hospitalizations, as well as many chronic complications that need to be managed over the long term. However, these complications can be prevented by maintaining correct glycemic control, according to international guidelines.
For the past few years, the arrival of new technologies as insulin pump and particularly Continuous Glucose Monitoring (CGM) showed a significant improvement on metabolic control.
Nevertheless, adolescents and young adults with type 1 diabetes need a special focus because they still fail to meet glycemic control targets.
At this time, hybrid closed loop, pairing Continuous Glucose Monitoring with insulin pump, enables insulin delivery in a semi-autonomous way thanks to algorithms, and leads to the best metabolic results we've never got in randomized trials and real-world studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Device: Hybrid closed loop (HCL)Patients between 15 and 25 years old with type 1 diabetes and treated by hybrid closed loop |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Tertiary care center from Centre Hospitalier Sud Francilien
Key inclusion criteria (3 listed)
- Patient aged between 15 and 25 years old
- Type 1 diabetes since at least 1 year at the moment of instauring HCL
- At least 3 months of HCL use
Key exclusion criteria (1 listed)
- Informed patient that have been opposed for their data collect
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 |
|---|---|---|
| Hybrid closed loop (HCL)* Control IQ : T-Slim pump with Dexcom G6 * Smartguard : Medtronic 780G pump with Guardian G4S * Diabeloop : Kaliedo pump with Dexcom G6 | Device | Group1 |
Primary outcome
HbA1c after HCL
Time frame: at 3 months
Comparison of HbA1c (%) before and after HCL (at least 3 months of use)
11 secondary outcomes
HbA1c after HCL
Time frame: at 6 months
HbA1c after HCL
Time frame: at 12 months
HbA1c after HCL
Time frame: at 24 months
Use of HCL
Time frame: at 3 months
HCL stop
Time frame: at 3 months
Glycemic parameters with CGM
Time frame: at 3 months
Glycemic parameters with CGM
Time frame: at 3 months
Glycemic parameters with CGM
Time frame: at 3 months
keto-acidosis and severe hypoglycemia
Time frame: at 3 months
retinopathy
Time frame: at 3 months
nephropathy
Time frame: at 3 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 26 Nov 2024.
- Derived from this study: PubMed 40208827Ung M, Penfornis A, Valentim C, Franc S, Amadou C, Eroukhmanoff J. Hybrid Closed Loop in Adolescents and Young Adults Living with Type 1 Diabetes: A Real-World Study. Diabetes Technol Ther. 2025 Sep;27(9):760-764. doi: 10.1089/dia.2024.0528. Epub 2025 Apr 10.
- 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.
Juliette EROUKHMANOFF, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1 Diabetes and Adolescents, run by Centre Hospitalier Sud Francilien 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 3 inclusion and 1 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 26 Nov 2024. 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?
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?
HbA1c after HCL (time frame: at 3 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 NCT06253351, 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 26 Nov 2024.