Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8) (DIABELOOP SP8)
Diabetes Mellitus, Type 1, Closed-Loop
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring Artificial Pancreas, Adolescents, Adults
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
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
Experimental
Active Comparator
36-week Closed-Loop
12-week open-loop and 24-week closed-loop
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