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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-06-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diabeloop for Highly Unstable Type 1 Diabetes

NCT04042207

Diabetes Mellitus, Type 1 Diabetes Mellitus, Brittle Closed-Loop

COMPLETED NA

Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

NCT02627911

Closed Loop Diabetes Mellitus, Type 1

COMPLETED PHASE2

Diabeloop for Teens

NCT04725591

Closed Loop Diabetes Mellitus, Type 1 Adolescents (12 to 17 Years Old)

COMPLETED NA

Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

NCT02987556

Closed Loop Diabetes Mellitus, Type 1

COMPLETED NA

Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity.

NCT01754181

Type 1 Diabetes

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1 Closed-Loop

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

36-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

Group Type EXPERIMENTAL

Open-loop condition

Intervention Type DEVICE

Patient's standard insulin pump setting combined with continuous glucose monitoring sensor

Closed-loop condition

Intervention Type DEVICE

Closed-loop algorithm system paired with continuous glucose monitoring sensor

12-week open-loop and 24-week closed-loop

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

Group Type ACTIVE_COMPARATOR

Open-loop condition

Intervention Type DEVICE

Patient's standard insulin pump setting combined with continuous glucose monitoring sensor

Closed-loop condition

Intervention Type DEVICE

Closed-loop algorithm system paired with continuous glucose monitoring sensor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open-loop condition

Patient's standard insulin pump setting combined with continuous glucose monitoring sensor

Intervention Type DEVICE

Closed-loop condition

Closed-loop algorithm system paired with continuous glucose monitoring sensor

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No