Back to resultsDiabeloop For Teens (DBL4T)
Primary Purpose
Closed Loop, Diabetes Mellitus, Type 1, Adolescents (12 to 17 Years Old)
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Dexcom G6 Continuous Glucose Monitoring
MEDISAFE WITH External Insulin Pump
Diabeloop Software (Model predictive control)
Declaration of meals
No declaration of meals
Remote monitoring (Telemedicine)
Sponsored by
About this trial
This is an interventional treatment trial for Closed Loop
Eligibility Criteria
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)
Sites / Locations
- University Hospitals LeuvenRecruiting
- Necker HospitalRecruiting
- Diabetes Center for Children and Adolescents Auf Der Bult
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diabeloop closed-loop glucose control session with the declaration of meals
Diabeloop closed-loop glucose control session without the declaration of meals
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
• Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
o >19.4 mmol/L or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
• Incidence of severe hyperglycemia
o Number of events requiring an emergency room visit or hospitalizations because of ketoacidosis (i.e. incidence of DKA)
• Percent of CGM time with glucose < 3.9 mmol/L
Measurement of glucose by CGM
• Percent of CGM time in glucose range 3.9-10.0 mmol/L
Measurement of glucose by CGM
• Mean CGM glucose
Measurement of glucose by CGM
• 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
• 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
• 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
• Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM
o > 19.4 mmol/L
• Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
• Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Measurement of glucose by CGM
• 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
• 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
• 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
• 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
• Evolution of HbA1c calculated from CGM data
Measurement of glucose by CGM
• Average CGM glucose level during the entire period
Measurement of glucose by CGM
• Average fasting CGM glucose level at 6:00 am
Measurement of glucose by CGM
• Variability of the CGM glucose level
the glycemic variation coefficient (CV) intra patient: CV < 36% CV ≥ 36%
Standard deviation (SD)
• Average dose of insulin used & its daily evolution during the entire study duration
• Number of technical incidents leading to the interruption of the closed loop
• 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
• Evolution of the weekly average number of CHO intake (for patient with closed-loop)
• Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating)
• Percentage of time spent in operating mode for the Dexcom G6 CGM
• Scoring of a questionnaire to evaluate the acceptance
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).
• Scoring of a questionnaire to evaluate the acceptance
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.
Full Information
NCT ID
NCT04725591
First Posted
January 13, 2021
Last Updated
February 16, 2023
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
1. Study Identification
Unique Protocol Identification Number
NCT04725591
Brief Title
Diabeloop For Teens
Acronym
DBL4T
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Loop, Diabetes Mellitus, Type 1, Adolescents (12 to 17 Years Old)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabeloop closed-loop glucose control session with the declaration of meals
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diabeloop closed-loop glucose control session without the declaration of meals
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dexcom G6 Continuous Glucose Monitoring
Intervention Description
Collection of glucose data
Intervention Type
Device
Intervention Name(s)
MEDISAFE WITH External Insulin Pump
Intervention Description
Insulin delivery
Intervention Type
Device
Intervention Name(s)
Diabeloop Software (Model predictive control)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Declaration of meals
Intervention Description
Patient inputs related to meals
Intervention Type
Other
Intervention Name(s)
No declaration of meals
Intervention Description
No patient inputs related to meals
Intervention Type
Other
Intervention Name(s)
Remote monitoring (Telemedicine)
Intervention Description
Remote follow up by care health providers team
Primary Outcome Measure Information:
Title
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).
Description
Measurement of glucose by CGM
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Incidence of severe hypoglycemia as defined by the ISPAD guidelines:
Description
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.
Time Frame
10 weeks
Title
• Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
Description
o >19.4 mmol/L or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
Time Frame
10 weeks
Title
• Incidence of severe hyperglycemia
Description
o Number of events requiring an emergency room visit or hospitalizations because of ketoacidosis (i.e. incidence of DKA)
Time Frame
10 weeks
Title
• Percent of CGM time with glucose < 3.9 mmol/L
Description
Measurement of glucose by CGM
Time Frame
10 weeks
Title
• Percent of CGM time in glucose range 3.9-10.0 mmol/L
Description
Measurement of glucose by CGM
Time Frame
10 weeks
Title
• Mean CGM glucose
Description
Measurement of glucose by CGM
Time Frame
10 weeks
Title
• 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
Description
< 2.8 mmol/L
< 3.0 mmol/L
< 3.3 mmol/L
< 3.9 mmol/L
Time Frame
24 hours
Title
• Number of hypoglycemic episodes with beginning and end of episode as measured by the Dexcom G6 CGM for at least 15 minutes
Description
< 3.9 mmol/L
< 3.0 mmol/L
≤ 2.8 mmol/L
Time Frame
10 weeks
Title
• 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
Description
> 10.0 mmol/L
> 13.9 mmol/L
> 16.7 mmol/L
> 19.4 mmol/L
Time Frame
24 hours
Title
• Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM
Description
o > 19.4 mmol/L
Time Frame
10 weeks
Title
• Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Time Frame
10 weeks
Title
• Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Description
Measurement of glucose by CGM
Time Frame
10 weeks
Title
• 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
Description
Measurement of glucose by CGM
Time Frame
2 weeks
Title
• 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
Description
Measurement of glucose by CGM
Time Frame
24 hours
Title
• 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
Description
Measurement of glucose by CGM
Time Frame
24 hours
Title
• 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
Description
Measurement of glucose by CGM
Time Frame
24 hours
Title
• Evolution of HbA1c calculated from CGM data
Description
Measurement of glucose by CGM
Time Frame
10 weeks
Title
• Average CGM glucose level during the entire period
Description
Measurement of glucose by CGM
Time Frame
10 weeks
Title
• Average fasting CGM glucose level at 6:00 am
Description
Measurement of glucose by CGM
Time Frame
10 weeks
Title
• Variability of the CGM glucose level
Description
the glycemic variation coefficient (CV) intra patient: CV < 36% CV ≥ 36%
Standard deviation (SD)
Time Frame
10 weeks
Title
• Average dose of insulin used & its daily evolution during the entire study duration
Time Frame
10 weeks
Title
• Number of technical incidents leading to the interruption of the closed loop
Time Frame
8 weeks
Title
• Evolution over time of the DBL system's performance on a day-to-day and determination of the optimization delay of glycemic control
Description
Measurement of glucose by CGM
Time Frame
8 weeks
Title
• Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Time Frame
8 weeks
Title
• Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating)
Time Frame
8 weeks
Title
• Percentage of time spent in operating mode for the Dexcom G6 CGM
Time Frame
10 weeks
Title
• Scoring of a questionnaire to evaluate the acceptance
Description
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).
Time Frame
10 weeks
Title
• Scoring of a questionnaire to evaluate the acceptance
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Charpentier
Phone
+33(0)1 64 96 86 52
Email
kerbonac@free.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Beltrand
Organizational Affiliation
Necker Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilde Morobé
Email
hilde.morobe@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Kristina Casteels
Facility Name
Necker Hospital
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Beltrand
Email
jacques.beltrand@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jacques Beltrand
First Name & Middle Initial & Last Name & Degree
Cécile Godot
Facility Name
Diabetes Center for Children and Adolescents Auf Der Bult
City
Hannover
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bärbel Aschemeier-Fuchs
Email
Aschemeier@hka.de
First Name & Middle Initial & Last Name & Degree
Thomas Danne
First Name & Middle Initial & Last Name & Degree
Felix RESCHKE
First Name & Middle Initial & Last Name & Degree
Torben BIESTER
First Name & Middle Initial & Last Name & Degree
Thekla VON DEM BERGE
First Name & Middle Initial & Last Name & Degree
Olga KORDONOURI
First Name & Middle Initial & Last Name & Degree
Jantje WEISKORN
12. IPD Sharing Statement
Learn more about this trial
Diabeloop For Teens
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