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NCT05331339 Clinical Trial

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)

Type 2 Diabetes Mellitus Clinical Trial

— INSULIA  

Official title:
Effectiveness in Real Life of the Insulia® Digital Tool in Patients With Type 2 Diabetes Treated With Basal Insulin Therapy as Part of a National Telemedicine Program (ETAPES)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05331339
Other study ID # 2022/0004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2022
Est. completion date December 2, 2022

Study information
Verified date February 2023
Source Centre Hospitalier Sud Francilien
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 2, 2022
Est. primary completion date December 2, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Exclusion Criteria: Patient opposed to the research

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Sud Francilien Corbeil-essonnes Cedex

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c Evolution of HbA1c between baseline and 6 months after Insulia initiation at 6 months
Secondary Insulin Evolution of daily dose of basal insulin between baseline and 6 months after Insulia initiation at 6 months
Secondary HbA1c objective Percentage of patients reaching the HbA1c target after 6 months at 6 months
Secondary Mean fasting glucose Percentage of patients reaching a mean fasting glucose < 150 mg/dL for 7 days after 6 months at 6 months
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