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

NCT04190277 | Terminated DMC

• 1 other identifier: 2019-A01975-52
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1; Closed-Loop

Keywords

Artificial Pancreas; Adolescents; Adults

Outcome Measures

Primary Outcomes (3)

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

  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)

  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)

  12-week period

Secondary Outcomes (28)

• 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)

  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)

  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

  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.

  36-week period

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

  36-week period

Study Arms (2)

36-week Closed-Loop

EXPERIMENTAL

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

Device: Open-loop condition; Device: Closed-loop condition

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

ACTIVE COMPARATOR

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

Device: Open-loop condition; Device: Closed-loop condition

Interventions

Open-loop condition DEVICE

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

12-week open-loop and 24-week closed-loop; 36-week Closed-Loop

Closed-loop condition DEVICE

Closed-loop algorithm system paired with continuous glucose monitoring sensor

12-week open-loop and 24-week closed-loop; 36-week Closed-Loop

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète: lead

Study Sites (9)

Caen University Hospital

Caen, 14033, France

Location

Sud Francilien Hospital

Corbeil-Essonnes, 91058, France

Location

Grenoble University Hospital

Grenoble, 38043, France

Location

Marseille - La Conception University Hospital

Marseille, 13005, France

Location

Necker-Enfants Malades University Hospital

Paris, 75015, France

Location

Reims University Hospital

Reims, 51092, France

Location

Strasbourg University Hospital

Strasbourg, 67000, France

Location

Toulouse - Purpan University Hospital

Toulouse, 31059, France

Location

Toulouse - Rangueil University Hospital

Toulouse, 31059, France

Location

Related Publications (1)

• Franc S, Reznik Y, Amadou C, Penfornis A, Schaepelynck P, Hanaire H, Delemer B, Le Tallec C, Beltrand J, Jeandidier N, Bensaid S, Orlando L, Hannaert P, Benhamou PY, Charpentier G. Safety and glycemic outcomes of DBLG1 coupled to the DANA-i pump in adults and adolescents with type 1 diabetes mellitus. The SP8 trial. J Endocrinol Invest. 2025 Dec 26. doi: 10.1007/s40618-025-02780-5. Online ahead of print.

  PMID: 41452442 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sylvia FRANC, Dr

  Sud Francilien Hospital, Corbeil-Essonnes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 9, 2019
• Study Start: January 7, 2020
• Primary Completion: March 16, 2020
• Study Completion: June 16, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)