INSULIA: Evaluation of the Insulia® Tool in Patients With Type 2 Diabetes Treated With Basal Insulin Therapy as Part of a National Telemedicine Program (ETAPES)

Sponsor

Centre Hospitalier Sud Francilien (Other)

Overall Status

Recruiting

CT.gov ID

NCT05331339

Collaborator

(none)

Enrollment

Location

8.2

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus

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 Design

Study Type:

Observational

Anticipated Enrollment :

96 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Anticipated Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

HbA1c [at 6 months]
Evolution of HbA1c between baseline and 6 months after Insulia initiation

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex		France	91106

Sponsors and Collaborators

Centre Hospitalier Sud Francilien

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Sud Francilien

ClinicalTrials.gov Identifier:

NCT05331339

Other Study ID Numbers:

2022/0004

First Posted:

Apr 15, 2022

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 28, 2022