Type 1 Diabetes Mellitus in Prepubertal ChildrenFREELIFE-KIDNCT03739099
Efficacy of Closed-loop Insulin Therapy in Prepubertal Child in Free-life
A study testing Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions in people with Type 1 Diabetes Mellitus in Prepubertal Children, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Type 1 Diabetes Mellitus in Prepubertal Children
- What is being tested?
- Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2018to 5 May 2023
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Treatment of diabetes by insulin pump since > 6 months
- HbA1c level < 10%
Who cannot join
- Unwillingness of one parent or the legally responsible party to participate in insulin treatment
- Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy of Closed-loop Insulin Therapy (Artificial Pancreas) on the Control of Type 1 Diabetes in Prepubertal Child in Free-life: Comparison Between Nocturnal and 24-hour Use on 18 Weeks, Followed by an Extension on 18 Weeks
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).
Read the detailed description
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. A hotline phone number will be given to the patient and parents so that they can contact the study staff as needed. A logbook will be provided to collect details about hypoglycemic and hyperglycemic episodes, physical activity and noticeable events. Phone calls will be scheduled between investigator and patient+parents 48 hours, 1 week and 2 weeks after AP mode initiation. Potential misbehaviors will be corrected and all questions answered. If needed, AP parameters may be revised and reconfigured. Hospital visits will be scheduled 6, 12 and 18 weeks after AP mode initiation for the same purposes, plus HbA1c measurement at week 12 and 18. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).
- Being tested
- Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions
- Keywords
- Type 1 diabetes, Prepubertal children, Closed-loop insulin infusion
- 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.
Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditionsDevice
Also called Artificial pancreas
Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop insulin delivery 24/7, day and night | Active comparator | Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm Receives: Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions |
| Closed-loop insulin delivery 7/7, dinner and night | Other | Closed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm Receives: Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data
% time blood glucose in 70-180 mg/dl range
Measured: 18 weeks
Secondary outcomes (8)
Percent of time spent with glucose level < 70, 60 and 50 mg/dl, assessed on daily CGM data
Percent time while blood glucose is kept in safe 70-180 mg/dl range
Measured: 18 and 36 weeks
Percent of time spent with glucose level > 180 and 300 mg/dl, assessed on daily CGM data
Percent time while blood glucose is kept in safe 70-180 mg/dl range
Measured: 18 and 36 weeks
Percent of time spent in the 70-140 mg/dl glucose range assessed on daily CGM data
Percent time while blood glucose is kept in safe 70-180 mg/dl range
Measured: 18 and 36 weeks
Mean glucose level assessed on daily CGM data
CGM data will be used to calculate daily glucose mean to assess the efficacy of the algorithm on glucose control.
Measured: 18 and 36 weeks
HbA1c level measured at week 12, 18, 27 and 36
Levels of glycated hemoglobin will be measured at different time intervals to assess the clinical impact of the use of the algorithm on patient diabetes.
Measured: 12,18, 27 and 36 weeks
Number of needed interventions by the patients or care providers to treat hypoglycemia
A logbook will be used all along the study by patients to record carbs intake in case of hypoglycemia. If patient required further assistance, care provider who will record third parties intervention.
Measured: 18 and 36 weeks
Percent of time with AP functional, discriminating between each component failure modes
Percent time while blood glucose is kept in safe 70-180 mg/dl range
Measured: 18 and 36 weeks
Score of the Artificial Pancreas Acceptance Questionnaire
This questionnaire consists of 15 affirmations about the use of AP and patient can answer in a scale from 0 (do not agree) to 6 (totally agree). The global score is calculated by the sum of all answers. A high score means a good acceptation of the system. There is no subscale.
Measured: 18 and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start5 Nov 2018
- Primary completion5 Sep 2022 (estimated)
- Study completion5 May 2023 (estimated)
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 Diabetes Mellitus in Prepubertal ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric M RENARD, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739099
- Sponsor's protocol ID
- UF 7580
- Acronym
- FREELIFE-KID
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2018
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coutant R, Bismuth E, Bonnemaison E, Dalla-Vale F, Morinais P, Perrard M, Trely J, Faure N, Bouhours-Nouet N, Levaillant L, Farret A, Storey C, Donzeau A, Poidvin A, Amsellem-Jager J, Place J, Quemener E, Hamel JF, Breton MD, Tubiana-Rufi N, Renard E. Hybrid Closed Loop Overcomes the Impact of Missed or Suboptimal Meal Boluses on Glucose Control in Children with Type 1 Diabetes Compared to Sensor-Augmented Pump Therapy. Diabetes Technol Ther. 2023 Jun;25(6):395-403. doi: 10.1089/dia.2022.0518. Epub 2023 Apr 6.
PubMed 36927054
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Closed-loop Insulin Therapy (Artificial Pancreas) on the Control of Type 1 Diabetes in Prepubertal Child in Free-life: Comparison Between Nocturnal and 24-hour Use on 18 Weeks, Followed by an Extension on 18 Weeks
- ClinicalTrials.gov ID
- NCT03739099
- Acronym / sponsor ID
- FREELIFE-KID / UF 7580
- Keywords
- Type 1 diabetes, Prepubertal children, Closed-loop insulin infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 5 Sep 2022 (estimated)
- Study completion
- 5 May 2023 (estimated)
- First posted
- 13 Nov 2018 (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 study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).
Detailed description
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. A hotline phone number will be given to the patient and parents so that they can contact the study staff as needed. A logbook will be provided to collect details about hypoglycemic and hyperglycemic episodes, physical activity and noticeable events. Phone calls will be scheduled between investigator and patient+parents 48 hours, 1 week and 2 weeks after AP mode initiation. Potential misbehaviors will be corrected and all questions answered. If needed, AP parameters may be revised and reconfigured. Hospital visits will be scheduled 6, 12 and 18 weeks after AP mode initiation for the same purposes, plus HbA1c measurement at week 12 and 18. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop insulin delivery 24/7, day and night | Active comparator | Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditionsClosed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm |
| Closed-loop insulin delivery 7/7, dinner and night | Other | Device: Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditionsClosed-loop subcutaneous insulin infusion driven by continuous glucose monitoring through an algorithm |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Treatment of diabetes by insulin pump since > 6 months
- HbA1c level < 10%
Key exclusion criteria (2 listed)
- Unwillingness of one parent or the legally responsible party to participate in insulin treatment
- Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
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-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditionsAlso: Artificial pancreasContinuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data | Device | Closed-loop insulin delivery 24/7, day and night, Closed-loop insulin delivery 7/7, dinner and night |
Primary outcome
Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data
Time frame: 18 weeks
% time blood glucose in 70-180 mg/dl range
8 secondary outcomes
Percent of time spent with glucose level < 70, 60 and 50 mg/dl, assessed on daily CGM data
Time frame: 18 and 36 weeks
Percent of time spent with glucose level > 180 and 300 mg/dl, assessed on daily CGM data
Time frame: 18 and 36 weeks
Percent of time spent in the 70-140 mg/dl glucose range assessed on daily CGM data
Time frame: 18 and 36 weeks
Mean glucose level assessed on daily CGM data
Time frame: 18 and 36 weeks
HbA1c level measured at week 12, 18, 27 and 36
Time frame: 12,18, 27 and 36 weeks
Number of needed interventions by the patients or care providers to treat hypoglycemia
Time frame: 18 and 36 weeks
Percent of time with AP functional, discriminating between each component failure modes
Time frame: 18 and 36 weeks
Score of the Artificial Pancreas Acceptance Questionnaire
Time frame: 18 and 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 36927054Coutant R, Bismuth E, Bonnemaison E, Dalla-Vale F, Morinais P, Perrard M, Trely J, Faure N, Bouhours-Nouet N, Levaillant L, Farret A, Storey C, Donzeau A, Poidvin A, Amsellem-Jager J, Place J, Quemener E, Hamel JF, Breton MD, Tubiana-Rufi N, Renard E. Hybrid Closed Loop Overcomes the Impact of Missed or Suboptimal Meal Boluses on Glucose Control in Children with Type 1 Diabetes Compared to Sensor-Augmented Pump Therapy. Diabetes Technol Ther. 2023 Jun;25(6):395-403. doi: 10.1089/dia.2022.0518. Epub 2023 Apr 6.
- Individual participant dataSharing planned: No
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.
Eric M RENARD, MD, PhD principal investigator
University Hospital, Montpellier
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 insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions in people with Type 1 Diabetes Mellitus in Prepubertal Children, run by University Hospital, Montpellier 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Dec 2021. 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?
Results are not available in the source record.
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?
Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data (time frame: 18 weeks). 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 NCT03739099, 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 16 Dec 2021.