Trials Sponsors Conditions Drugs Pricing

Conditions

Closed-Loop Diabetes Mellitus, Type 1

Keywords

Artificial PancreasAdolescentsAdults

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 conditionDevice: 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 conditionDevice: Closed-loop condition

Interventions

Open-loop conditionDevice

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

12-week open-loop and 24-week closed-loop36-week Closed-Loop

Closed-loop conditionDevice

Closed-loop algorithm system paired with continuous glucose monitoring sensor

Eligibility Criteria

Age14 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

age 14 - 75 years at time of screening
Type 1 diabetes

Sponsors & Collaborators

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Otherlead

Study Sites (9)

Caen University Hospital

Caen, 14033, France

Sud Francilien Hospital

Corbeil-Essonnes, 91058, France

Grenoble University Hospital

Grenoble, 38043, France

Marseille - La Conception University Hospital

Marseille, 13005, France

Necker-Enfants Malades University Hospital

Paris, 75015, France

Reims University Hospital

Reims, 51092, France

Strasbourg University Hospital

Strasbourg, 67000, France

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. 2026 Apr;49(4):959-968. doi: 10.1007/s40618-025-02780-5. Epub 2025 Dec 26.
PMID: 41452442DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Sylvia FRANC, Dr
Sud Francilien Hospital, Corbeil-Essonnes
PRINCIPAL INVESTIGATOR

Enrollment

184 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (28)

Study Arms (2)

36-week Closed-Loop

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (28)

Study Arms (2)

36-week Closed-Loop

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations