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

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

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.

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