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OpenTrials
Completed

NCT Number: NCT05331339

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)

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HbA1c

    Time frame: at 6 months

    Evolution of HbA1c between baseline and 6 months after Insulia initiation

Secondary outcomes

  1. Insulin

    Time frame: at 6 months

    Evolution of daily dose of basal insulin between baseline and 6 months after Insulia initiation

  2. HbA1c objective

    Time frame: at 6 months

    Percentage of patients reaching the HbA1c target after 6 months

  3. Mean fasting glucose

    Time frame: at 6 months

    Percentage of patients reaching a mean fasting glucose < 150 mg/dL for 7 days after 6 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study 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)

Acronym: INSULIA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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