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Evaluation of the Efficacy and Safety of DBL-4pen Mobile Application in Patients With Type 2 Diabetes

NCT05733962 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-07

No results posted yet for this study

Summary

This study conducted in 40 adults living with type 2 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), the patient will start a 42-day treatment period during which he will use the DBL-4pen application and two Mallya connected caps, in addition to the Dexcom G6 CGM. An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of DBL-4pen application.

The main objective is to evaluate the safety and efficacy of the DBL-4pen system for 6 weeks in patients with type 2 diabetes.

Data related to efficacy of DBL-4pen, global safety of DBL-4pen, compliance with recommended insulin injections, satisfaction with the system 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 2

Interventions

DEVICE

Use of the device DBL-4pen

During the treatment period, the patient will use * the DBL-4pen device (consisting of a software hosting the Diabeloop algorithm installed on a smartphone) * the associated device #1: Dexcom G6, Continuous Glucose Monitoring (CGM) * the associated device #2: Two Mallya caps for their rapid- and long-acting insulin pens. The regulation algorithm hosted by DBL-4pen software recommends insulin doses to be administrated by the patient.

Sponsors & Collaborators

  • Icadom

    collaborator INDUSTRY

  • Diabeloop

    lead INDUSTRY

Principal Investigators

  • Pierre-Yves BENHAMOU · University Hospital, Grenoble

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-12-31
Completion
2025-01-31

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 NCT05733962 on ClinicalTrials.gov