Real-life Efficacy of Insulia® Tool in Patients Living with Type 2 Diabetes Treated with Basal Insulin Therapy As Part of a National Telemedicine Program (ETAPES)

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT05331339
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief Summary

The purpose of this study was to evaluate the INSULIA digital tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) in a single-center study.

The assumption is that a better metabolic control with this tool.

Detailed Description

Basal insulin titration in people with type 2 diabetes is of major importance to obtain the optimal dose to regulate fasting blood glucose without hypoglycemia.

Significant inertia in treatment optimization has been observed among both general practitioners and diabetologists.

The INSULIA tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) has been supported by the health authorities.

The data collected are of a single-center cohort of adult patients with type 2 diabetes who used this tool between 2018 and 2021.

It is supposed that a better metabolic control with this tool and aimed to understand factors associated with better results.

Study Timeline

• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2022-11-02
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Age ≥ 18 years old.
• Patients with type 2 diabetes.
• Initiation or adjustment of basal insulin.
• Prescription of Insulia® for more than 6 months (between august 2018 and june 2021)
• Informed patient not opposed to the research

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Exclusion Criteria

Patient opposed to the research

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c	at 6 months	Evolution of HbA1c between baseline and 6 months after Insulia initiation

Secondary Outcome Measures

Name	Time	Method
HbA1c objective	at 6 months	Percentage of patients reaching the HbA1c target after 6 months
Insulin	at 6 months	Evolution of daily dose of basal insulin between baseline and 6 months after Insulia initiation
Mean fasting glucose	at 6 months	Percentage of patients reaching a mean fasting glucose \< 150 mg/dL for 7 days after 6 months

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France