- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725591
Diabeloop For Teens (DBL4T)
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guillaume Charpentier
- Phone Number: +33(0)1 64 96 86 52
- Email: kerbonac@free.fr
Study Locations
-
-
-
Leuven, Belgium
- Recruiting
- University Hospitals Leuven
-
Contact:
- Hilde Morobé
- Email: hilde.morobe@uzleuven.be
-
Principal Investigator:
- Kristina Casteels
-
-
-
-
-
Paris, France
- Recruiting
- Necker Hospital
-
Contact:
- Jacques Beltrand
- Email: jacques.beltrand@aphp.fr
-
Principal Investigator:
- Jacques BELTRAND
-
Sub-Investigator:
- Cécile Godot
-
-
-
-
-
Hannover, Germany
- Not yet recruiting
- Diabetes Center for Children and Adolescents Auf Der Bult
-
Contact:
- Bärbel Aschemeier-Fuchs
- Email: Aschemeier@hka.de
-
Sub-Investigator:
- Felix RESCHKE
-
Sub-Investigator:
- Torben BIESTER
-
Sub-Investigator:
- Thekla VON DEM BERGE
-
Sub-Investigator:
- Olga KORDONOURI
-
Sub-Investigator:
- Jantje WEISKORN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
- 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
Exclusion Criteria:
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)
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Diabeloop closed-loop glucose control session with the declaration of meals
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. |
Collection of glucose data
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.
Patient inputs related to meals
Remote follow up by care health providers team
Insulin delivery
|
Experimental: Diabeloop closed-loop glucose control session without the declaration of meals
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. |
Collection of glucose data
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 follow up by care health providers team
No patient inputs related to meals
Insulin delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of severe hypoglycemia as defined by the ISPAD guidelines:
Time Frame: 10 weeks
|
|
10 weeks
|
• Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
Time Frame: 10 weeks
|
o >19.4 mmol/L or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
|
10 weeks
|
• Incidence of severe hyperglycemia
Time Frame: 10 weeks
|
o Number of events requiring an emergency room visit or hospitalizations because of ketoacidosis (i.e.
incidence of DKA)
|
10 weeks
|
• Percent of CGM time with glucose < 3.9 mmol/L
Time Frame: 10 weeks
|
Measurement of glucose by CGM
|
10 weeks
|
• Percent of CGM time in glucose range 3.9-10.0 mmol/L
Time Frame: 10 weeks
|
Measurement of glucose by CGM
|
10 weeks
|
• Mean CGM glucose
Time Frame: 10 weeks
|
Measurement of glucose by CGM
|
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
|
|
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
|
|
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
|
|
24 hours
|
• Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM
Time Frame: 10 weeks
|
o > 19.4 mmol/L
|
10 weeks
|
• Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Time Frame: 10 weeks
|
10 weeks
|
|
• Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Time Frame: 10 weeks
|
Measurement of glucose by CGM
|
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
|
Measurement of glucose by CGM
|
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
|
Measurement of glucose by CGM
|
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
|
Measurement of glucose by CGM
|
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
|
Measurement of glucose by CGM
|
24 hours
|
• Evolution of HbA1c calculated from CGM data
Time Frame: 10 weeks
|
Measurement of glucose by CGM
|
10 weeks
|
• Average CGM glucose level during the entire period
Time Frame: 10 weeks
|
Measurement of glucose by CGM
|
10 weeks
|
• Average fasting CGM glucose level at 6:00 am
Time Frame: 10 weeks
|
Measurement of glucose by CGM
|
10 weeks
|
• Variability of the CGM glucose level
Time Frame: 10 weeks
|
|
10 weeks
|
• Average dose of insulin used & its daily evolution during the entire study duration
Time Frame: 10 weeks
|
10 weeks
|
|
• Number of technical incidents leading to the interruption of the closed loop
Time Frame: 8 weeks
|
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
|
Measurement of glucose by CGM
|
8 weeks
|
• Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Time Frame: 8 weeks
|
8 weeks
|
|
• Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating)
Time Frame: 8 weeks
|
8 weeks
|
|
• Percentage of time spent in operating mode for the Dexcom G6 CGM
Time Frame: 10 weeks
|
10 weeks
|
|
• Scoring of a questionnaire to evaluate the acceptance
Time Frame: 10 weeks
|
o 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.
|
10 weeks
|
• Scoring of a questionnaire to evaluate the acceptance
Time Frame: 10 weeks
|
o 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).
|
10 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacques Beltrand, Necker Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A02132-37
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 1
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on Dexcom G6 Continuous Glucose Monitoring
-
University of East AngliaCompletedDiabetes | HypoglycaemiaUnited Kingdom
-
Medical University of GdanskNot yet recruitingHyperglycemia | Infections | Hypoglycemia | Surgical Site Infection | PeritonitisPoland
-
Scripps Translational Science InstituteTempus Labs; CareEvolution Healthcare TechnologyActive, not recruiting
-
Emory UniversityCompletedEnd Stage Kidney DiseaseUnited States
-
Medical University of ViennaRecruitingPregnancy Complications | Blood Glucose | Gestational Diabetes | GDM | CgmAustria
-
Charles University, Czech RepublicUnknownDiabetes Mellitus, Type 1Czechia
-
University of SurreyUK Civil Aviation Authority; Irish Civil Aviation Authority; Austrian Civil Aviation...SuspendedType 1 DiabetesAustria, Ireland, United Kingdom
-
University of California, IrvineDexCom, Inc.Active, not recruitingDiabetes | Hemodialysis | Glucose MeasurementUnited States
-
MemorialCare Health SystemDexCom, Inc.RecruitingHyperinsulinism | Hypoglycemia NeonatalUnited States
-
The Cleveland ClinicDexCom, Inc.Active, not recruitingSurgery--ComplicationsUnited States