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Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8) (DIABELOOP SP8)

Primary Purpose

Diabetes Mellitus, Type 1, Closed-Loop

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Open-loop condition
Closed-loop condition
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring Artificial Pancreas, Adolescents, Adults

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 14 - 75 years at time of screening
  • Type 1 diabetes
  • Subject has a clinical diagnosis of type 1 diabetes for at least 2 years as determined via medical records or source documentation by an individual qualified to make a medical diagnosis.
  • An insulin pump user for at least 6 months (with or without CGM experience),
  • 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
  • Has TSH in the normal range
  • if subject has celiac disease, it has been adequately treated as determined by the investigator
  • With history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening and a stress test within 6 months prior to screening or during screening. If subject has an abnormal stress test, he will not be allowed to participate in the study, unless there is clearance from a cardiologist. If subject fails stress test, participation is allowed only if there is clearance from a cardiologist

  • With 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist. Cardiovascular risk factors include:

    • Age >35 years
    • Type 1 diabetes of >15 years' duration
    • Presence of any additional risk factor for coronary artery disease
    • Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
    • Presence of peripheral vascular disease
    • Presence of autonomic neuropathy
  • Must be able to speak and be literate in French
  • For adults (18 - 75 years old): having provided written informed consent
  • For adolescents (14 - 17 years old): having provided written assent & parents/guardian having provided written informed consent

Exclusion Criteria:

  • Patient receiving a total daily dose of insulin lower than 8 U
  • Patient with a daily dose of insulin required greater than 90 units
  • Patient having severe problems of uncorrected hearing and/or visual acuity
  • Patient unable to understand and perform all of the instructions provided by Diabeloop SA
  • 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

Sites / Locations

  • Caen University Hospital
  • Sud Francilien Hospital
  • Grenoble University Hospital
  • Marseille - La Conception University Hospital
  • Necker-Enfants Malades University Hospital
  • Reims University Hospital
  • Strasbourg University Hospital
  • Toulouse - Purpan University Hospital
  • Toulouse - Rangueil University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

36-week Closed-Loop

12-week open-loop and 24-week closed-loop

Arm Description

2-week baseline period in open-loop condition, then 12-week period in closed-loop condition followed by a 24-week extension period in closed-loop condition

2-week baseline period in open-loop condition, then 12-week period in open-loop condition followed by a 24-week extension period in closed-loop condition

Outcomes

Primary Outcome Measures

Incidence rate of Serious Adverse Device Effect occuring during the 12-week closed-loop period
Percentage of time spent in hypoglycemia (glucose level below 70mg/dL (3.9 mmol/L)) between baseline period (2-week period) and in-home study phase in closed-loop (12-week period) for the whole patients of the "single-arm" part
as recorded by continuous subcutaneous glucose monitoring (CGM)
Difference in percentage of time spent in hypoglycemia (<70mg/dL) during 12 weeks between closed-loop and open-loop
as recorded by continuous subcutaneous glucose monitoring (CGM)

Secondary Outcome Measures

Percentage of sensor time in glucose level o < 50mg/dL (2.8 mmol/L) o < 60 mg/dL (3.3 mmol/L) o < 70mg/dL (3.9 mmol/L)
measured by the Dexcom G6 CGM
Number of hypoglycemic episodes with beginning and end of episode o < 70 mg/dL (3.9 mmol/L) o ≤ 54 mg/dL (3 mmol/L)
as measured by the Dexcom G6 CGM
Incidence of severe hypoglycemia: o Number of severe hypoglycemic episodes needing a third-party intervention o Number of severe hypoglycemic episodes with loss of consciousness o Number of hospitalizations because of a severe hypoglycemia episode
Number of severe hyperglycemia episodes with beginning and end of episode : o > 350 mg/dL (19.4 mmol/L) o > 360 mg/dL (20 mmol/L) or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
as measured by the Dexcom G6 CGM
Incidence of severe hyperglycemia: o Number of hospitalizations because of ketoacidosis (i.e. incidence of DKA)
Number of technical incidents leading to the interruption of the closed loop
Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Area under the curve (AUC) from CGM analysis
Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Low Blood Glucose Interstitial & High Blood Glucose Interstitial as measured by the Dexcom G6 CGM
Percentage of time spent in the 70-180 mg/dL target range
as recorded by continuous subcutaneous glucose monitoring (CGM)
Percentage of time spent in the 70-180 mg/dL target range
as recorded by continuous subcutaneous glucose monitoring (CGM)
Percentage of sensor time in glucose level : o < 50 mg/dL (2.8 mmol/L), o < 54 mg/dL (3.0 mmol/L) o < 60 mg/dL (3.3 mmol/L), o < 70 mg/dL (3.9 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Percentage of sensor time in glucose range 54-70 mg/dL (3.0 - 3.9 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Percentage of sensor time in glucose range 70-140 mg/dL (3.9 - 7.8 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Percentage of sensor time in glucose level o > 180 mg/dL (10.0 mmol/L), o > 250 mg/dL (13.9 mmol/L), o > 300 mg/dL (16.7 mmol/L) o > 350 mg/dL (19.4 mmol/L)
as recorded by continuous subcutaneous glucose monitoring (CGM)
Evolution of glycosylated hemoglobin between inclusion and end of study
calculated from CGM data and measured by blood sampling
Average glycemia level during the entire period
as measured by the Dexcom G6 CGM
Average fasting glycemia level at 6:00 am
as measured by the Dexcom G6 CGM
Variability of the glycemia level measured by o the glycemic variation coefficient (CV) intra patient: • CV < 36% • CV ≥ 36% o Standard deviation (SD)
Average dose of insulin used & its daily evolution during the entire study duration
Evolution over time of the DBLUS system's performance on a day-to-day and determination of the optimization delay of glycemic control
Percentage of time spent in closed loop mode (i.e. DBLUS System with loop mode operating)
Percentage of time spent in operating mode for the Dexcom G6 CGM
Scoring of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) to evaluate the acceptance
Scoring of the Diabetes Quality of Life (DQOL) questionnaire to evaluate the acceptance
Scoring of the Hypoglycemia Fear Survey (HFS) questionnaire to evaluate the acceptance
Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Questionnaire of usability (for 50 subjects from Arm 1, including 15 adolescents and 35 adults)

Full Information

First Posted
November 19, 2019
Last Updated
April 6, 2021
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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1. Study Identification

Unique Protocol Identification Number
NCT04190277
Brief Title
Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8)
Acronym
DIABELOOP SP8
Official Title
Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy in a Randomized Trial for 3 Months Followed by an Extension Period
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Covid-19
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
June 16, 2020 (Actual)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial is a randomized trial including a 3-month single-arm part and a 6-month extension phase. Following randomization between the 1st group and 2nd group, a 2-week baseline period in open-loop for 148 adults and 30 adolescents will be performed. Patients will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6. Then, a 3-month study phase will be performed during 12 weeks: 1st group (111 adults randomized from 148 adults and 30 adolescents) will receive the treatment via the Closed-loop System (closed-loop condition). 2nd group (37 adult controls randomized from 148 adults) will receive the standard of care treatment including their usual subcutaneous insulin pump augmented with continuous glucose measurement with Dexcom G6 (open loop condition). An extension period of 6 months with the Closed-loop System (closed-loop condition) will be performed at the end of the study phase for all patients enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Closed-Loop
Keywords
Artificial Pancreas, Adolescents, Adults

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
36-week Closed-Loop
Arm Type
Experimental
Arm Description
2-week baseline period in open-loop condition, then 12-week period in closed-loop condition followed by a 24-week extension period in closed-loop condition
Arm Title
12-week open-loop and 24-week closed-loop
Arm Type
Active Comparator
Arm Description
2-week baseline period in open-loop condition, then 12-week period in open-loop condition followed by a 24-week extension period in closed-loop condition
Intervention Type
Device
Intervention Name(s)
Open-loop condition
Intervention Description
Patient's standard insulin pump setting combined with continuous glucose monitoring sensor
Intervention Type
Device
Intervention Name(s)
Closed-loop condition
Intervention Description
Closed-loop algorithm system paired with continuous glucose monitoring sensor
Primary Outcome Measure Information:
Title
Incidence rate of Serious Adverse Device Effect occuring during the 12-week closed-loop period
Time Frame
12-weeks closed-loop period
Title
Percentage of time spent in hypoglycemia (glucose level below 70mg/dL (3.9 mmol/L)) between baseline period (2-week period) and in-home study phase in closed-loop (12-week period) for the whole patients of the "single-arm" part
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
14-week baseline & closed-loop period
Title
Difference in percentage of time spent in hypoglycemia (<70mg/dL) during 12 weeks between closed-loop and open-loop
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
12-week period
Secondary Outcome Measure Information:
Title
Percentage of sensor time in glucose level o < 50mg/dL (2.8 mmol/L) o < 60 mg/dL (3.3 mmol/L) o < 70mg/dL (3.9 mmol/L)
Description
measured by the Dexcom G6 CGM
Time Frame
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 throughout the 38-week study
Title
Number of hypoglycemic episodes with beginning and end of episode o < 70 mg/dL (3.9 mmol/L) o ≤ 54 mg/dL (3 mmol/L)
Description
as measured by the Dexcom G6 CGM
Time Frame
36-week period
Title
Incidence of severe hypoglycemia: o Number of severe hypoglycemic episodes needing a third-party intervention o Number of severe hypoglycemic episodes with loss of consciousness o Number of hospitalizations because of a severe hypoglycemia episode
Time Frame
36-week period
Title
Number of severe hyperglycemia episodes with beginning and end of episode : o > 350 mg/dL (19.4 mmol/L) o > 360 mg/dL (20 mmol/L) or significant ketosis (plasmatic ketones > 3 mmol/L) as defined by the ADA.
Description
as measured by the Dexcom G6 CGM
Time Frame
36-week period
Title
Incidence of severe hyperglycemia: o Number of hospitalizations because of ketoacidosis (i.e. incidence of DKA)
Time Frame
36-week period
Title
Number of technical incidents leading to the interruption of the closed loop
Time Frame
36-week period
Title
Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
Time Frame
36-week period
Title
Area under the curve (AUC) from CGM analysis
Time Frame
36-week period
Title
Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
Description
Low Blood Glucose Interstitial & High Blood Glucose Interstitial as measured by the Dexcom G6 CGM
Time Frame
36-week period
Title
Percentage of time spent in the 70-180 mg/dL target range
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
during 12 weeks 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 throughout the 38-week study
Title
Percentage of time spent in the 70-180 mg/dL target range
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
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 throughout the 38-week study
Title
Percentage of sensor time in glucose level : o < 50 mg/dL (2.8 mmol/L), o < 54 mg/dL (3.0 mmol/L) o < 60 mg/dL (3.3 mmol/L), o < 70 mg/dL (3.9 mmol/L)
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
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 throughout the 38-week study
Title
Percentage of sensor time in glucose range 54-70 mg/dL (3.0 - 3.9 mmol/L)
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
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 throughout the 38-week study
Title
Percentage of sensor time in glucose range 70-140 mg/dL (3.9 - 7.8 mmol/L)
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
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 throughout the 38-week study
Title
Percentage of sensor time in glucose level o > 180 mg/dL (10.0 mmol/L), o > 250 mg/dL (13.9 mmol/L), o > 300 mg/dL (16.7 mmol/L) o > 350 mg/dL (19.4 mmol/L)
Description
as recorded by continuous subcutaneous glucose monitoring (CGM)
Time Frame
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 throughout the 38-week study
Title
Evolution of glycosylated hemoglobin between inclusion and end of study
Description
calculated from CGM data and measured by blood sampling
Time Frame
at inclusion, after 12-week period, after 24-week extension period
Title
Average glycemia level during the entire period
Description
as measured by the Dexcom G6 CGM
Time Frame
36-week period
Title
Average fasting glycemia level at 6:00 am
Description
as measured by the Dexcom G6 CGM
Time Frame
36-week period
Title
Variability of the glycemia level measured by o the glycemic variation coefficient (CV) intra patient: • CV < 36% • CV ≥ 36% o Standard deviation (SD)
Time Frame
36-week period
Title
Average dose of insulin used & its daily evolution during the entire study duration
Time Frame
36-week period
Title
Evolution over time of the DBLUS system's performance on a day-to-day and determination of the optimization delay of glycemic control
Time Frame
36-week period
Title
Percentage of time spent in closed loop mode (i.e. DBLUS System with loop mode operating)
Time Frame
36-week period
Title
Percentage of time spent in operating mode for the Dexcom G6 CGM
Time Frame
36-week period
Title
Scoring of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) to evaluate the acceptance
Time Frame
after baseline period (2-week); after12-week-period; after 24-week extension period
Title
Scoring of the Diabetes Quality of Life (DQOL) questionnaire to evaluate the acceptance
Time Frame
after baseline period (2-week); after12-week-period; after 24-week extension period
Title
Scoring of the Hypoglycemia Fear Survey (HFS) questionnaire to evaluate the acceptance
Time Frame
after baseline period (2-week); after12-week-period; after 24-week extension period
Title
Evolution of the weekly average number of CHO intake (for patient with closed-loop)
Time Frame
36-week period
Title
Questionnaire of usability (for 50 subjects from Arm 1, including 15 adolescents and 35 adults)
Time Frame
after 4 weeks of closed-loop; after 12 weeks of closed-loop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 14 - 75 years at time of screening Type 1 diabetes Subject has a clinical diagnosis of type 1 diabetes for at least 2 years as determined via medical records or source documentation by an individual qualified to make a medical diagnosis. An insulin pump user for at least 6 months (with or without CGM experience), 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 Has TSH in the normal range if subject has celiac disease, it has been adequately treated as determined by the investigator With history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening and a stress test within 6 months prior to screening or during screening. If subject has an abnormal stress test, he will not be allowed to participate in the study, unless there is clearance from a cardiologist. If subject fails stress test, participation is allowed only if there is clearance from a cardiologist With 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist. Cardiovascular risk factors include: Age >35 years Type 1 diabetes of >15 years' duration Presence of any additional risk factor for coronary artery disease Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria) Presence of peripheral vascular disease Presence of autonomic neuropathy Must be able to speak and be literate in French For adults (18 - 75 years old): having provided written informed consent For adolescents (14 - 17 years old): having provided written assent & parents/guardian having provided written informed consent Exclusion Criteria: Patient receiving a total daily dose of insulin lower than 8 U Patient with a daily dose of insulin required greater than 90 units Patient having severe problems of uncorrected hearing and/or visual acuity Patient unable to understand and perform all of the instructions provided by Diabeloop SA 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia FRANC, Dr
Organizational Affiliation
Sud Francilien Hospital, Corbeil-Essonnes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Sud Francilien Hospital
City
Corbeil-Essonnes
ZIP/Postal Code
91058
Country
France
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Marseille - La Conception University Hospital
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Necker-Enfants Malades University Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Reims University Hospital
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Strasbourg University Hospital
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Toulouse - Purpan University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Toulouse - Rangueil University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8)

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