Closed LoopDBL4KNCT03671915

Diabeloop for Kids

A study testing Continuous Glucose Monitoring, External Insulin Pump and Remote monitoring (Telemedicine) in people with Closed Loop and Diabetes Mellitus, Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up home study phase, crossover study comparing Diabeloop closed-loop (CL) system and sensor-augmented pump (SAP) therapy. The follow-up home study phase will be done only in French centers for a sub study. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Closed Loop, Diabetes Mellitus, Type 1, Young Children (6 to 12 Years Old )
What is being tested?: Continuous Glucose Monitoring, External Insulin Pump and Remote monitoring (Telemedicine)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 3 sitesin 2 countries
Study dates: 6 May 2019to 23 Dec 2019
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

Prepubescent children (Gender: both) aged between 6 to 12 years old (Tanner stage 1) at time of screening
Type 1 diabetes as defined by WHO for at least 1 year or confirmed C peptide negative
An insulin pump user for at least 3 months.
Subject having a Glycosylated hemoglobin (HbA1c) blood value < 9% at time of screening visit-based on analysis from local laboratory within 3 months.
Subject having a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
Subject and his parent/guardian willing to spend 3-overnight in hospital.
Subject willing to wear the system continuously throughout the study
Subjects and his parent/guardian must be able to speak and be literate in French or Flemish as verified by the investigator

Who cannot join

Children who are in pubertal stage
Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: - Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) - Coma - Seizures
Subject having sever DKA in the 6 months prior to screening visit.
Known or suspected allergy against insulin
Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.
Subject is unable to tolerate tape adhesive around the sensor or pump placements
Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
Subject having took any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the study.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

France2 sites

Necker Enfants Malades Hospital
Paris, 75015
Toulouse University Hospital Center
Toulouse, 31059

Other trials in France

Belgium1 site

University Hospitals Leuven
Leuven, 3000

Other trials in Belgium

About this study

Official title: An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Control Compared With Sensor-augmented Pump Therapy, in Young Children With Type 1 Diabetes.

The follow-up home study phase will be done only in French centers for a sub study. During this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote monitoring follow-up by specialized nurses, under supervision of a diabetologist. A visualization of glucose CGM curves, insulin delivery, meal and physical activity announcements will be available online through secured website, and the system will send automated message in case of predetermined situations as persistent too high or too low Blood Glucose (BG). Custom settings will be possible by the nurses during the follow-up period.

Conditions: Closed Loop, Diabetes Mellitus, Type 1, Young Children (6 to 12 Years Old )
Being tested: Continuous Glucose Monitoring, External Insulin Pump, Diabeloop Software (Model predictive control), Remote monitoring (Telemedicine)
Keywords: artificial pancreas
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.

Continuous Glucose MonitoringDevice
collection of glucose data
External Insulin PumpDevice
Insulin delivery
Diabeloop Software (Model predictive control)Device
Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
Remote monitoring (Telemedicine)Other
Remote follow up by care health providers team

Study groups in NCT03671915
Study group	Role	What they receive
Usual System (Open-loop)	Active comparator	In open loop: sensor-augmented pump (SAP) therapy using standard insulin pump setting combined with the six-generation glucose sensor (Dexcom G6). Receives: Device: Continuous Glucose Monitoring; Device: External Insulin Pump
DIABELOOP System (Closed-loop)	Experimental	In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump. A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session. Receives: Device: Continuous Glucose Monitoring; Device: External Insulin Pump; Device: Diabeloop Software (Model predictive control); Other: Remote monitoring (Telemedicine)

What is being measured

The primary outcome is the main question the study is designed to answer.

The time spent of the glucose level drop in below 70 mg/dl over the 72-h, as recorded by continuous subcutaneous glucose monitoring (CGM).
Measurement of glucose by CGM
Measured: 72 hours

Secondary outcomes (15)

Sensor mean glucose
Sensor mean glucose over the 72-h, in the overnight (defined as 23:00 to 07:00) and during the home study phase for the French centers, in closed-loop and open-loop session
Measured: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Coefficient of variation (SD/Mean %)
Measured: 72 hours
Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM
Measurement of glucose by CGM
Measured: 72 hours
Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)
Measurement of glucose by CGM
Measured: 72 hours and 6 weeks (home study phase)
Percentage of sensor time in glucose range 70-140 mg/dl
Measurement of glucose by CGM
Measured: 72 hours and 6 weeks (home study phase)
Percentage time in glucose levels in the widened target range 70-180 mg/dl
Measurement of glucose by CGM
Measured: 72 hours and 6 weeks (home study phase)
Fasting blood glucose, mg/dl (mmol/L)
Measured: 72 hours and 6 weeks
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl
Measurement of glucose by CGM
Measured: 72 hours
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl
Measurement of glucose by CGM
Measured: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia
Measurement of glucose by CGM
Measured: 72 hours and 6 weeks (home study phase)
Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl
Measurement of glucose by CGM
Measured: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Severe Diabetic Ketoacidosis (DKA) events
Subjects will be asked to measure blood urine ketone levels on waking in the morning if their finger-stick glucose is above 200 mg/l, as part of the safety evaluation for hyperglycemia.
Measured: 72 hours and 6 weeks (home study phase)
Percentage of time closed-loop active
Measured: 72 hours and 6 weeks (home study phase)
Total daily dose of insulin
Total basal and bolus by 24h
Measured: 72 hours and 6 weeks (home study phase)
Subject's perception in terms of life-style change, satisfaction and diabetes management
Subject's perception in terms of life-style change, satisfaction and diabetes management as evaluated by PedsQL, DTQ, DTSQ and AP acceptance questionnaire.
Measured: 72 hours and 6 weeks (home study phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 201923 Dec 2019

First posted14 Sep 2018
Study start6 May 2019
Primary completion23 Dec 2019
Study completion23 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Closed LoopStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Closed loop vs. Open loop
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03671915
Sponsor's protocol ID: 2018-A02078-47
Acronym: DBL4K
Status last verified: Mar 2020
First submitted: 13 Sep 2018
Last updated: 6 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Benhamou PY, Adenis A, Tourki Y, Pou S, Madrolle S, Franc S, Kariyawasam D, Beltrand J, Klonoff DC, Charpentier G. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol. 2024 Mar;18(2):372-379. doi: 10.1177/19322968221128565. Epub 2022 Sep 29.
PubMed 36172702
Kariyawasam D, Morin C, Casteels K, Le Tallec C, Sfez A, Godot C, Huneker E, Garrec N, Benhamou PY, Polak M, Charpentier G, Franc S, Beltrand J. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6-12 years: a randomised, controlled, cross-over, non-inferiority trial. Lancet Digit Health. 2022 Mar;4(3):e158-e168. doi: 10.1016/S2589-7500(21)00271-5.
PubMed 35216750

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Control Compared With Sensor-augmented Pump Therapy, in Young Children With Type 1 Diabetes.
ClinicalTrials.gov ID: NCT03671915
Acronym / sponsor ID: DBL4K / 2018-A02078-47
Conditions: Closed Loop, Diabetes Mellitus, Type 1, Young Children (6 to 12 Years Old )
Keywords: artificial pancreas
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
Study start: 6 May 2019 (actual)
Primary completion: 23 Dec 2019 (actual)
Study completion: 23 Dec 2019 (actual)
First posted: 14 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Closed loop vs. Open loop

Arm	Type	Receives
Usual System (Open-loop)	Active comparator	Device: Continuous Glucose Monitoring, Device: External Insulin PumpIn open loop: sensor-augmented pump (SAP) therapy using standard insulin pump setting combined with the six-generation glucose sensor (Dexcom G6).
DIABELOOP System (Closed-loop)	Experimental	Device: Continuous Glucose Monitoring, Device: External Insulin Pump, Device: Diabeloop Software (Model predictive control), Other: Remote monitoring (Telemedicine)In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump. A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session.

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Prepubescent children (Gender: both) aged between 6 to 12 years old (Tanner stage 1) at time of screening
Type 1 diabetes as defined by WHO for at least 1 year or confirmed C peptide negative
An insulin pump user for at least 3 months.
Subject having a Glycosylated hemoglobin (HbA1c) blood value < 9% at time of screening visit-based on analysis from local laboratory within 3 months.
Subject having a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.

Key exclusion criteria (8 listed)

Children who are in pubertal stage
Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: - Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) - Coma - Seizures
Subject having sever DKA in the 6 months prior to screening visit.
Known or suspected allergy against insulin
Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.

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
Continuous Glucose Monitoringcollection of glucose data	Device	DIABELOOP System (Closed-loop), Usual System (Open-loop)
External Insulin PumpInsulin delivery	Device	DIABELOOP System (Closed-loop), Usual System (Open-loop)
Diabeloop Software (Model predictive control)Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.	Device	DIABELOOP System (Closed-loop)
Remote monitoring (Telemedicine)Remote follow up by care health providers team	Other	DIABELOOP System (Closed-loop)

Primary outcome

The time spent of the glucose level drop in below 70 mg/dl over the 72-h, as recorded by continuous subcutaneous glucose monitoring (CGM).
Time frame: 72 hours
Measurement of glucose by CGM

15 secondary outcomes

Sensor mean glucose
Time frame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Coefficient of variation (SD/Mean %)
Time frame: 72 hours
Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM
Time frame: 72 hours
Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)
Time frame: 72 hours and 6 weeks (home study phase)
Percentage of sensor time in glucose range 70-140 mg/dl
Time frame: 72 hours and 6 weeks (home study phase)
Percentage time in glucose levels in the widened target range 70-180 mg/dl
Time frame: 72 hours and 6 weeks (home study phase)
Fasting blood glucose, mg/dl (mmol/L)
Time frame: 72 hours and 6 weeks
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl
Time frame: 72 hours
Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl
Time frame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia
Time frame: 72 hours and 6 weeks (home study phase)
Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl
Time frame: 72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase)
Severe Diabetic Ketoacidosis (DKA) events
Time frame: 72 hours and 6 weeks (home study phase)
Percentage of time closed-loop active
Time frame: 72 hours and 6 weeks (home study phase)
Total daily dose of insulin
Time frame: 72 hours and 6 weeks (home study phase)
Subject's perception in terms of life-style change, satisfaction and diabetes management
Time frame: 72 hours and 6 weeks (home study phase)

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 6 Mar 2020.
Derived from this study: PubMed 36172702Benhamou PY, Adenis A, Tourki Y, Pou S, Madrolle S, Franc S, Kariyawasam D, Beltrand J, Klonoff DC, Charpentier G. Efficacy of a Hybrid Closed-Loop Solution in Patients With Excessive Time in Hypoglycaemia: A Post Hoc Analysis of Trials With DBLG1 System. J Diabetes Sci Technol. 2024 Mar;18(2):372-379. doi: 10.1177/19322968221128565. Epub 2022 Sep 29.
Derived from this study: PubMed 35216750Kariyawasam D, Morin C, Casteels K, Le Tallec C, Sfez A, Godot C, Huneker E, Garrec N, Benhamou PY, Polak M, Charpentier G, Franc S, Beltrand J. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6-12 years: a randomised, controlled, cross-over, non-inferiority trial. Lancet Digit Health. 2022 Mar;4(3):e158-e168. doi: 10.1016/S2589-7500(21)00271-5.
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.

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 8 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Belgium. 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?

The time spent of the glucose level drop in below 70 mg/dl over the 72-h, as recorded by continuous subcutaneous glucose monitoring (CGM). (time frame: 72 hours). 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 NCT03671915, which also lists 2 linked publications.

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 6 Mar 2020.