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, 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.
Inclusion Criteria:
Device-related inclusion criteria
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:
Subject having severe diabetic ketoacidosis in the 6 months prior to screening visit
Impaired awareness of hypoglycemia (Gold Score > 4)