DBL4T
An Open-label, Multicenter, Randomized, Crossover Study, to Assess 4 Weeks Outpatient, the Clinical Efficacy of the Diabeloop Closed-loop Glucose Control Without the Declaration of Meals Compared with the Diabeloop Closed-loop Glucose Control with the Declaration of Meals, in Adolescent Patients with Type 1 Diabetes Poorly Controlled.
Sponsor study identifier
interventional
49
3 countries
3
Study Start
January 25, 2023
Actual (reported)Primary Completion
February 14, 2024
Actual (reported)Study Completion
May 19, 2024
Actual (reported)An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 19, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2021
Actual (reported)January 26, 2021
Actual (reported)January 25, 2023
Actual (reported)February 14, 2024
Actual (reported)May 19, 2024
Actual (reported)The primary outcome is the time spent of the glucose level in the widened target range 3.9-10.0 mmol/L over the 2 last weeks of each cross-over period, as recorded by continuous subcutaneous glucose monitoring (CGM).
Measurement of glucose by CGM
2 weeks
Incidence of severe hypoglycemia as defined by the ISPAD guidelines:
10 weeks
• Number of severe hyperglycemia episodes with beginning and end episode as measured by the Dexcom G6 CGM
10 weeks
• Incidence of severe hyperglycemia
10 weeks
• Percent of CGM time with glucose < 3.9 mmol/L
10 weeks
• Percent of CGM time in glucose range 3.9-10.0 mmol/L
10 weeks
Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump. Subjects are asked to declare their meals for 4 weeks. A remote monitoring system is provided in closed-loop session.
Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and MEDISAFE WITH insulin pump. Subjects are asked to not declare their meals for 4 weeks. A remote monitoring system is provided in closed-loop session.
Collection of glucose data
Insulin delivery
University Hospitals Leuven
Leuven, Belgium
Necker Hospital
Paris, France
Diabetes Center for Children and Adolescents Auf Der Bult
Hanover, Germany
Jacques Beltrand
Necker Hospital
49 participants (actual enrollment reported by the registry).
First Submitted
January 13, 2021
First Posted
January 26, 2021
Study Start
January 25, 2023
Actual (reported)Diabeloop for Highly Unstable Type 1 Diabetes
Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
Patient inputs related to meals
No patient inputs related to meals
Remote follow up by care health providers team
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 14, 2024
Actual (reported)Study Completion
May 19, 2024
Actual (reported)Last Updated
September 26, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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