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

NCT05733962 | Unknown DMC

• 1 other identifier: RCB 2022-A00478-35
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

regulation algorithm; Diabetes; Treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in 70 - 180 mg/dL glycemic range

  Impact of the use of DBL-4pen on the time spent in the target 70-180 mg/dL during the main treatment period compared to baseline, in percentage.

  56 days

Secondary Outcomes (16)

• Percentage of time spent in specific glycemic ranges

  98 days

• Mean CGM glycemia

  98 days

• Variability of the glucose level

  98 days

• Glucose management indicator (GMI)

  98 days

• Evolution of HbA1c for patients accepting the extension phase

  98 days

Study Arms (1)

Use of the device DBL-4pen

EXPERIMENTAL

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 with the DBL-4pen system followed by an optional 42-day extension period.

Device: Use of the device DBL-4pen

Interventions

Use of the device DBL-4pen DEVICE

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.

Use of the device DBL-4pen

Eligibility Criteria

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

You may qualify if:

• Patients under basal-bolus scheme for type 2 diabetes
• Patients aged ≥ 18 years old
• Patients using rapid-acting analog and long-acting analog that are compatible with Mallya cap (Lispro, Detemir, Aspart, Glargine, Glulisine) with a stable insulin therapy regimen for at least the past 90 days (no modification of the number of injections and no more than 10% variation of the total daily dose)
• Patients using insulin with a concentration 100 U/mL
• Patients having an HbA1c ≤ 10%
• Patients who agree to use Dexcom G6 as CGM
• Patients living in an area covered by phone network
• Patients must be affiliated to any kind of social security
• Patients must be able to speak and be literate in French
• Non-isolated patients, not living alone, or having a "resource" person living nearby and having a telephone and the key of his home
• Having signed the free and informed consent form
• Subject equipped with a CGM for at least the past 90 days
• Patients with Total Daily Dose (TDD) \< 10 U
• Patients suffering from a serious illness or undergoing treatment that might significantly impair diabetes physiology, i.e. glucose-insulin interactions, that might interfere with the medical device (for example irregular treatment by steroids).
• Patients with severe uncorrected hearing impairment and/or severe uncorrected proble- ms of visual acuity.

Sponsors & Collaborators

• Diabeloop: lead
• Icadom: collaborator

Study Sites (4)

CH Sud Francilien

Corbeil-Essonnes, 91100, France

Location

CHU Grenoble

Grenoble, 38000, France

Location

CHRU de Strasbourg - Hôpital Civil

Strasbourg, 67000, France

Location

CHU Toulouse - Hôpital de Rangueil

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pierre-Yves BENHAMOU

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin CHATEL

CONTACT

+33781862065; benjamin.chatel@diabeloop.fr

Lenka STYFALOVA

CONTACT

+33769889863; lenka.styfalova@diabeloop.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: interventional single-arm open-label before/after multicentric national study

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: February 17, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

FR (4)