NCT04190277 - Safety Assessment of DBLUS System in Adolescent and Adult Patients With Type 1 Diabetes and Assessment of Its Clinical Efficacy (DIABELOOP SP8) | Crick

Eligibility

Sex: ALLMin age: 14 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence rate of Serious Adverse Device Effect occuring during the 12-week closed-loop period

Time frame: 12-weeks 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)

Time frame: 14-week baseline & closed-loop period

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)

Time frame: 12-week period

Secondary Outcomes

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

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

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

Time frame: 36-week period

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

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

Time frame: 36-week period

Incidence of severe hyperglycemia: o Number of hospitalizations because of ketoacidosis (i.e. incidence of DKA)

Time frame: 36-week period

Number of technical incidents leading to the interruption of the closed loop

Time frame: 36-week period

Number of serious adverse events, serious adverse device events, unanticipated adverse device effects

Time frame: 36-week period

Area under the curve (AUC) from CGM analysis

Time frame: 36-week period

Risk of hypoglycemia and hyperglycemia (LBGI/HBGI)

Low Blood Glucose Interstitial \& High Blood Glucose Interstitial as measured by the Dexcom G6 CGM

Time frame: 36-week period

Percentage of time spent in the 70-180 mg/dL target range

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

Percentage of time spent in the 70-180 mg/dL target range

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

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)

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

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)

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

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)

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

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)

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

Evolution of glycosylated hemoglobin between inclusion and end of study

calculated from CGM data and measured by blood sampling

Time frame: at inclusion, after 12-week period, after 24-week extension period

Average glycemia level during the entire period

as measured by the Dexcom G6 CGM

Time frame: 36-week period

Average fasting glycemia level at 6:00 am

as measured by the Dexcom G6 CGM

Time frame: 36-week period

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

Average dose of insulin used & its daily evolution during the entire study duration

Time frame: 36-week period

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

Percentage of time spent in closed loop mode (i.e. DBLUS System with loop mode operating)

Time frame: 36-week period

Percentage of time spent in operating mode for the Dexcom G6 CGM

Time frame: 36-week period

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

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

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

Evolution of the weekly average number of CHO intake (for patient with closed-loop)

Time frame: 36-week period

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

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

Overview

Conditions

Interventions

Eligibility

Locations (9)

Outcomes

Primary Outcomes

Secondary Outcomes