Clinical trial NCT04725591: Diabeloop for Teens
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
Overall status: COMPLETED
Phase: NA
Conditions: Closed Loop
Diabetes Mellitus, Type 1
Adolescents (12 to 17 Years Old)
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 49
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
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).
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of severe hypoglycemia as defined by the ISPAD guidelines:
timeFrame: 10 weeks
measure: • Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
timeFrame: 10 weeks
measure: • Incidence of severe hyperglycemia
timeFrame: 10 weeks
measure: • Percent of CGM time with glucose < 3.9 mmol/L
timeFrame: 10 weeks
measure: • Percent of CGM time in glucose range 3.9-10.0 mmol/L
timeFrame: 10 weeks
measure: • Mean CGM glucose
timeFrame: 10 weeks
measure: • 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
timeFrame: 24 hours
measure: • Number of hypoglycemic episodes with beginning and end of episode as measured by the Dexcom G6 CGM for at least 15 minutes
timeFrame: 10 weeks
measure: • 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
timeFrame: 24 hours
measure: • Number of severe hyperglycemia episodes with beginning and end of episode as measured by the Dexcom G6 CGM
timeFrame: 10 weeks
measure: • Number of serious adverse events, serious adverse device events, unanticipated adverse device effects
timeFrame: 10 weeks
measure: • Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)
timeFrame: 10 weeks
measure: • 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
timeFrame: 2 weeks
measure: • 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
timeFrame: 24 hours
measure: • 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
timeFrame: 24 hours
measure: • 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
timeFrame: 24 hours
measure: • Evolution of HbA1c calculated from CGM data
timeFrame: 10 weeks
measure: • Average CGM glucose level during the entire period
timeFrame: 10 weeks
measure: • Average fasting CGM glucose level at 6:00 am
timeFrame: 10 weeks
measure: • Variability of the CGM glucose level
timeFrame: 10 weeks
measure: • Average dose of insulin used & its daily evolution during the entire study duration
timeFrame: 10 weeks
measure: • Number of technical incidents leading to the interruption of the closed loop
timeFrame: 8 weeks
measure: • Evolution over time of the DBL system's performance on a day-to-day and determination of the optimization delay of glycemic control
timeFrame: 8 weeks
measure: • Evolution of the weekly average number of CHO intake (for patient with closed-loop)
timeFrame: 8 weeks
measure: • Percentage of time spent in closed loop mode (i.e. DBL System with loop mode operating)
timeFrame: 8 weeks
measure: • Percentage of time spent in operating mode for the Dexcom G6 CGM
timeFrame: 10 weeks
measure: • Scoring of a questionnaire to evaluate the acceptance
timeFrame: 10 weeks
measure: • Scoring of a questionnaire to evaluate the acceptance
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Paris
country: France
facility: Necker Hospital
city: Hannover
country: Germany
facility: Diabetes Center for Children and Adolescents Auf Der Bult
Study officials:
affiliation: Necker Hospital
name: Jacques Beltrand
role: PRINCIPAL_INVESTIGATOR
References: