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DBLG1 System With TERUMO MEDISAFE WITH Insulin Pump Trial

NCT05628532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-07

No results posted yet for this study

Summary

This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62.

After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period during which he will use the DBLG1 System, a closed loop system (including a DBLG1 handset, a TERUMO MEDISAFE WITH insulin pump, in addition to his Dexcom G6 CGM). An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of the DBLG1 system.

The main objective is to evaluate the safety and efficacy of the DBLG1 System with a TERUMO MEDISAFE WITH insulin pump in closed-loop for 6 weeks in 90 adults with type 1 diabetes.

Data related to their glycemia, complications, usability and quality of life will be collected.

The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Use of the DBLG1 system

During the treatment period, the patient will use the DBLG1 system (consisting of a DBLG1 handset with an embedded software named loop mode, a TERUMO MEDISAFE WITH patch pump and a Dexcom continuous glucose monitoring (CGM) G6). The main function of DBLG1 System is to adjust the insulin delivery at the correct time in order to maintain the patient's blood glucose in the target range and thus minimize both hypoglycaemic events and long-term complications associated with elevated average glycemia.

Sponsors & Collaborators

  • Icadom

    collaborator INDUSTRY

  • Diabeloop

    lead INDUSTRY

Principal Investigators

  • Alfred PENFORNIS, Pr · CH Sud Francilien

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2024-02-21
Completion
2024-04-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628532 on ClinicalTrials.gov