Closed LoopDBL4TNCT04725591
Diabeloop for Teens
A study testing Dexcom G6 Continuous Glucose Monitoring, MEDISAFE WITH External Insulin Pump and Declaration of meals 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 3 countries.
Trial summary
An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Closed Loop, Diabetes Mellitus, Type 1, Adolescents (12 to 17 Years Old)
- What is being tested?
- Dexcom G6 Continuous Glucose Monitoring, MEDISAFE WITH External Insulin Pump and Declaration of meals
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Jan 2023to 19 May 2024
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Device-related inclusion criteria
- age 12 - <18 years (i.e 17 years and 364 days) at time of screening
- Type 1 diabetes Study-specific inclusion criteria
- Subject has a clinical diagnosis of type 1 diabetes for at least 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis or confirmed C peptide negative.
- An insulin pump user, or patient under Multiple Daily Injection (MDI), with or without CGM experience.
- Subject having a Glycosylated hemoglobin (HbA1c) blood value > 8 % at time of screening visit-based on analysis from local laboratory within 3 months.
Show all 11Show fewer
- Living in an area covered by a GSM (Global System for Mobile Communications) network
- Patient not isolated, does not live alone, or has a person living nearby who has a telephone and a key to his or her home
- Patient willing to wear the system continuously throughout the study
- Must be able to speak and be literate in French, in Dutch or in German
- Having provided written assent \& parents/guardian having provided written informed consent
Who cannot join
- Device-related exclusion criteria
- Patient receiving a total daily dose of insulin lower than 8 U
- Patient having severe uncorrected problems of hearing and/or visual acuity
- Patient unable to understand and perform all of the instructions provided by Diabeloop SA Study-specific exclusion criteria
- Subject is unable to tolerate tape adhesive around the sensor or pump placements
- Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
Show all 38Show fewer
- Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Is being treated for hyperthyroidism at time of screening
- Has diagnosis of adrenal insufficiency
- Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the study
- Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
- Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
- Currently abusing illicit drugs
- Currently abusing marijuana
- Currently abusing prescription drugs
- Currently abusing alcohol
- Subject is using pramlintide (Symlin), DDP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
- Subject has elective surgery planned that requires general anesthesia during the study
- Has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Plans to receive red blood cell transfusion or erythropoietin over study participation
- Diagnosed with current eating disorder such as anorexia or bulimia
- Diagnosed with chronic kidney disease that results in chronic anemia
- Hematocrit that is below the normal reference range of lab used
- Patient who has had a pancreatectomy or who has pancreatic malfunctions
- Patient with pancreatic islet transplantation or pancreas transplantation
- Patient on dialysis
- Patient with impaired hepatic functions
- Serum creatinine > 176 µmol/L
- 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.
- Pregnancy or breastfeeding
- Untreated coeliac disease (2 x ULN local laboratory)
- Untreated or unstable thyroid disease
- Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any of the following during the 6 months prior to screening:
- Medical assistance (i.e. Paramedics, Emergency Room or Hospitalization)
- Coma
- Seizures
- Subject having severe diabetic ketoacidosis in the 6 months prior to screening visit
- Impaired awareness of hypoglycemia (Gold Score > 4)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Diabetes Center for Children and Adolescents Auf Der Bult
Hanover
About this study
Official title: An Open-label, Multicenter, Randomized, Crossover Study, to Assess 4 Weeks Outpatient, the Clinical Efficacy of the Diabeloop Closed-loop Glucose Control Without the Declaration of Meals Compared with the Diabeloop Closed-loop Glucose Control with the Declaration of Meals, in Adolescent Patients with Type 1 Diabetes Poorly Controlled.
An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.
- Being tested
- Dexcom G6 Continuous Glucose Monitoring, MEDISAFE WITH External Insulin Pump, Diabeloop Software (Model predictive control), Declaration of meals, No declaration of meals
- 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.
Dexcom G6 Continuous Glucose MonitoringDevice
Collection of glucose data
MEDISAFE WITH 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.
Declaration of mealsOther
Patient inputs related to meals
No declaration of mealsOther
No patient inputs related to meals
Remote monitoring (Telemedicine)Other
Remote follow up by care health providers team
| Study group | Role | What they receive |
|---|---|---|
| Diabeloop closed-loop glucose control session with the declaration of meals | Active comparator | Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump.
Subjects are asked to declare their meals for 4 weeks.
A remote monitoring system is provided in closed-loop session. Receives: Device: Dexcom G6 Continuous Glucose Monitoring; Device: MEDISAFE WITH External Insulin Pump; Device: Diabeloop Software (Model predictive control); Other: Declaration of meals; Other: Remote monitoring (Telemedicine) |
| Diabeloop closed-loop glucose control session without the declaration of meals | Experimental | Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump.
Subjects are asked to not declare their meals for 4 weeks.
A remote monitoring system is provided in closed-loop session. Receives: Device: Dexcom G6 Continuous Glucose Monitoring; Device: MEDISAFE WITH External Insulin Pump; Device: Diabeloop Software (Model predictive control); Other: No declaration of meals; Other: Remote monitoring (Telemedicine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the time spent of the glucose level in the widened target range 3.9-10.0 mmol/L over the 2 last weeks of each cross-over period, as recorded by continuous subcutaneous glucose monitoring (CGM).
Measurement of glucose by CGM
Measured: 2 weeks
Secondary outcomes (28)
Incidence of severe hypoglycemia as defined by the ISPAD guidelines:
- Number of severe hypoglycemic episodes needing a third-party intervention
- Number of severe hypoglycemic episodes with loss of consciousness
- Number of hospitalizations because of a severe hypoglycemia episode
- Number of hypoglycemic episodes, defined by any crossing of the threshold of 3.33 mmol/L, 3.9 mmol/L, 3.0mmol/L and < 2.8 mmol/L measured continuous glucose monitoring.
Measured: 10 weeks
• Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
- >19.4 mmol/L or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
Measured: 10 weeks
• Incidence of severe hyperglycemia
- Number of events requiring an emergency room visit or hospitalizations because of ketoacidosis (i.e. incidence of DKA)
Measured: 10 weeks
• Percent of CGM time with glucose < 3.9 mmol/L
Measurement of glucose by CGM
Measured: 10 weeks
• Percent of CGM time in glucose range 3.9-10.0 mmol/L
Measurement of glucose by CGM
Measured: 10 weeks
• Mean CGM glucose
Measurement of glucose by CGM
Measured: 10 weeks
• Percentage of sensor time in glucose level measured by the Dexcom G6 CGM, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
- < 2.8 mmol/L
- < 3.0 mmol/L
- < 3.3 mmol/L
- < 3.9 mmol/L
Measured: 24 hours
• Number of hypoglycemic episodes with beginning and end of episode as measured by the Dexcom G6 CGM for at least 15 minutes
- < 3.9 mmol/L
- < 3.0 mmol/L
- ≤ 2.8 mmol/L
Measured: 10 weeks
• Percentage of sensor time in glucose level measured by the Dexcom G6 CGM, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
- > 10.0 mmol/L
- > 13.9 mmol/L
- > 16.7 mmol/L
- > 19.4 mmol/L
Measured: 24 hours
• Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM
- > 19.4 mmol/L
Measured: 10 weeks
• Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Measured: 10 weeks
• Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Measurement of glucose by CGM
Measured: 10 weeks
• Percentage of time spent in the 3.9-10.0 mmol/L target range, for the last 2 weeks of each cross-over session during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Measurement of glucose by CGM
Measured: 2 weeks
• Percentage of sensor time in glucose range 2.8 - 3.9 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Measurement of glucose by CGM
Measured: 24 hours
• Percentage of sensor time in glucose range 3.9 - 7.8 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Measurement of glucose by CGM
Measured: 24 hours
• Percentage of sensor time in glucose range 3.9 - 10.0 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Measurement of glucose by CGM
Measured: 24 hours
• Evolution of HbA1c calculated from CGM data
Measurement of glucose by CGM
Measured: 10 weeks
• Average CGM glucose level during the entire period
Measurement of glucose by CGM
Measured: 10 weeks
• Average fasting CGM glucose level at 6:00 am
Measurement of glucose by CGM
Measured: 10 weeks
• Variability of the CGM glucose level
- the glycemic variation coefficient (CV) intra patient: CV < 36% CV ≥ 36%
- Standard deviation (SD)
Measured: 10 weeks
• Average dose of insulin used & its daily evolution during the entire study duration
Measured: 10 weeks
• Number of technical incidents leading to the interruption of the closed loop
Measured: 8 weeks
• Evolution over time of the DBL system's performance on a day-to-day and determination of the optimization delay of glycemic control
Measurement of glucose by CGM
Measured: 8 weeks
• Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Measured: 8 weeks
• Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating)
Measured: 8 weeks
• Percentage of time spent in operating mode for the Dexcom G6 CGM
Measured: 10 weeks
• Scoring of a questionnaire to evaluate the acceptance
- Diabetes Treatment Satisfaction Questionnaire (DTSQ) is a 12-item measure that enables self-reporting of the satisfaction about their current treatment. Scale is from 6 (very satisfied) to 0 (very dissatisfied).
Measured: 10 weeks
• Scoring of a questionnaire to evaluate the acceptance
- Diabetes Technology Questionnaire (DTQ) aims to evaluate the impact of the closed-loop system use and diabetes specific quality of life measures in the study participants and their families, as well as satisfaction of system, as compared to conventional treatment options. The subject will answer by choosing from 5 suggestions : Strongly agree - Agree - Neither agree nor disagree - Disagree - Strongly disagree.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start25 Jan 2023
- Primary completion14 Feb 2024
- Study completion19 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Beltrand, Principal investigator, Necker Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725591
- Sponsor's protocol ID
- 2020-A02132-37
- Acronym
- DBL4T
- Status last verified
- Sep 2024
- First submitted
- 13 Jan 2021
- Last updated
- 26 Sep 2024
- 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 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Randomized, Crossover Study, to Assess 4 Weeks Outpatient, the Clinical Efficacy of the Diabeloop Closed-loop Glucose Control Without the Declaration of Meals Compared with the Diabeloop Closed-loop Glucose Control with the Declaration of Meals, in Adolescent Patients with Type 1 Diabetes Poorly Controlled.
- ClinicalTrials.gov ID
- NCT04725591
- Acronym / sponsor ID
- DBL4T / 2020-A02132-37
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 19 May 2024 (actual)
- First posted
- 26 Jan 2021 (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.
An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabeloop closed-loop glucose control session with the declaration of meals | Active comparator | Device: Dexcom G6 Continuous Glucose Monitoring, Device: MEDISAFE WITH External Insulin Pump, Device: Diabeloop Software (Model predictive control), Other: Declaration of meals, Other: Remote monitoring (Telemedicine)Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump. Subjects are asked to declare their meals for 4 weeks. A remote monitoring system is provided in closed-loop session. |
| Diabeloop closed-loop glucose control session without the declaration of meals | Experimental | Device: Dexcom G6 Continuous Glucose Monitoring, Device: MEDISAFE WITH External Insulin Pump, Device: Diabeloop Software (Model predictive control), Other: No declaration of meals, Other: Remote monitoring (Telemedicine)Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump. Subjects are asked to not declare their meals for 4 weeks. A remote monitoring system is provided in closed-loop session. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Device-related inclusion criteria
- age 12 - <18 years (i.e 17 years and 364 days) at time of screening
- Type 1 diabetes Study-specific inclusion criteria
- Subject has a clinical diagnosis of type 1 diabetes for at least 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis or confirmed C peptide negative.
- An insulin pump user, or patient under Multiple Daily Injection (MDI), with or without CGM experience.
Key exclusion criteria (38 listed)
- Device-related exclusion criteria
- Patient receiving a total daily dose of insulin lower than 8 U
- Patient having severe uncorrected problems of hearing and/or visual acuity
- Patient unable to understand and perform all of the instructions provided by Diabeloop SA Study-specific exclusion criteria
- Subject is unable to tolerate tape adhesive around the sensor or pump placements
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 |
|---|---|---|
| Dexcom G6 Continuous Glucose MonitoringCollection of glucose data | Device | Diabeloop closed-loop glucose control session with the declaration of meals, Diabeloop closed-loop glucose control session without the declaration of meals |
| MEDISAFE WITH External Insulin PumpInsulin delivery | Device | Diabeloop closed-loop glucose control session with the declaration of meals, Diabeloop closed-loop glucose control session without the declaration of meals |
| 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 closed-loop glucose control session with the declaration of meals, Diabeloop closed-loop glucose control session without the declaration of meals |
| Declaration of mealsPatient inputs related to meals | Other | Diabeloop closed-loop glucose control session with the declaration of meals |
| No declaration of mealsNo patient inputs related to meals | Other | Diabeloop closed-loop glucose control session without the declaration of meals |
| Remote monitoring (Telemedicine)Remote follow up by care health providers team | Other | Diabeloop closed-loop glucose control session with the declaration of meals, Diabeloop closed-loop glucose control session without the declaration of meals |
Primary outcome
The primary outcome is the time spent of the glucose level in the widened target range 3.9-10.0 mmol/L over the 2 last weeks of each cross-over period, as recorded by continuous subcutaneous glucose monitoring (CGM).
Time frame: 2 weeks
Measurement of glucose by CGM
28 secondary outcomes
Incidence of severe hypoglycemia as defined by the ISPAD guidelines:
Time frame: 10 weeks
• Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
Time frame: 10 weeks
• Incidence of severe hyperglycemia
Time frame: 10 weeks
• Percent of CGM time with glucose < 3.9 mmol/L
Time frame: 10 weeks
• Percent of CGM time in glucose range 3.9-10.0 mmol/L
Time frame: 10 weeks
• Mean CGM glucose
Time frame: 10 weeks
• Percentage of sensor time in glucose level measured by the Dexcom G6 CGM, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Time frame: 24 hours
• Number of hypoglycemic episodes with beginning and end of episode as measured by the Dexcom G6 CGM for at least 15 minutes
Time frame: 10 weeks
• Percentage of sensor time in glucose level measured by the Dexcom G6 CGM, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Time frame: 24 hours
• Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM
Time frame: 10 weeks
• Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Time frame: 10 weeks
• Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Time frame: 10 weeks
• Percentage of time spent in the 3.9-10.0 mmol/L target range, for the last 2 weeks of each cross-over session during nights, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Time frame: 2 weeks
• Percentage of sensor time in glucose range 2.8 - 3.9 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Time frame: 24 hours
• Percentage of sensor time in glucose range 3.9 - 7.8 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Time frame: 24 hours
• Percentage of sensor time in glucose range 3.9 - 10.0 mmol/L, for 24 hours (12:00am-12:00am) and during the following periods: from 12:00am to 6:00am, from 6:00am to 12:00am
Time frame: 24 hours
• Evolution of HbA1c calculated from CGM data
Time frame: 10 weeks
• Average CGM glucose level during the entire period
Time frame: 10 weeks
• Average fasting CGM glucose level at 6:00 am
Time frame: 10 weeks
• Variability of the CGM glucose level
Time frame: 10 weeks
• Average dose of insulin used & its daily evolution during the entire study duration
Time frame: 10 weeks
• Number of technical incidents leading to the interruption of the closed loop
Time frame: 8 weeks
• Evolution over time of the DBL system's performance on a day-to-day and determination of the optimization delay of glycemic control
Time frame: 8 weeks
• Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Time frame: 8 weeks
• Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating)
Time frame: 8 weeks
• Percentage of time spent in operating mode for the Dexcom G6 CGM
Time frame: 10 weeks
• Scoring of a questionnaire to evaluate the acceptance
Time frame: 10 weeks
• Scoring of a questionnaire to evaluate the acceptance
Time frame: 10 weeks
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 Sep 2024.
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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.
Jacques Beltrand principal investigator
Necker Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 Continuous Glucose Monitoring, MEDISAFE WITH External Insulin Pump and Declaration of meals 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 3 countries.
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 11 inclusion and 38 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 Sep 2024. 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 Belgium, France, Germany. 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 primary outcome is the time spent of the glucose level in the widened target range 3.9-10.0 mmol/L over the 2 last weeks of each cross-over period, as recorded by continuous subcutaneous glucose monitoring (CGM). (time frame: 2 weeks). 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 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.