NCT05676593

Brief Summary

Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes. The benefit of therapeutic education (TPE) has been clearly established on glycaemic control. Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications. The investigators therefore propose a prospective randomised study in 2 arms :

  • a group of people living with diabetes receiving standard TPE vs
  • a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 3, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

December 6, 2022

Last Update Submit

November 6, 2023

Conditions

EndocrinologyType 2 Diabetes

Keywords

SensorTherapeutic educationDiabeteGlucose

Outcome Measures

Primary Outcomes (1)

  • Rate of change in glycated hemoglobine at 3 months

    biological control of glycated hemoglobin in a laboratory

    3 months

Secondary Outcomes (10)

  • Rate of change of the time in range, time above range and time below range

    6 months

  • Rate of change in glycated hemoglobin at 6 months

    6 months

  • Rate of change in weight in kg

    In kg each 3,6 months

  • Quality of Life questionnary

    Set a score out of 100 (100 good good quality of life - 0 bad quality of life) performed at 3,6 months

  • Rate of change arteriel pressure

    In mmHg each 3,6 months

  • +5 more secondary outcomes

Study Arms (2)

People living with diabete standard TPE

ACTIVE COMPARATOR

HBA1c at 3 and 6 months Therapeutic education Auto questionnary on Aviitam plateform at 3 and 6 months

Other: Therapeutic education

People living with diabete standard TPE + FSL 28 days

EXPERIMENTAL

Continuous mesure of glucose (FSL2) during 28 days at enrollment Therapeutic education HBA1c at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months Auto questionnary on Aviitam plateform at 3 and 6 months

Device: Freestyle Libre 2Other: Therapeutic education

Interventions

Freestyle Libre 2DEVICE

The FSL will be placed on patient for 28 days to measure interstitial glucose

People living with diabete standard TPE + FSL 28 days
Therapeutic educationOTHER

Therapeutic education

People living with diabete standard TPEPeople living with diabete standard TPE + FSL 28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recently diagnosed diabete mellitus (\<1 an) treated by non medical therapeutics and/or metformine
  • \> 18 years old
  • initial glycated hemoglobin between 7 and 8.5%

You may not qualify if:

  • Person whose physical and/or psychological health is severely impaired
  • Person deprived of his rights, person under guardianship or curatorship
  • Person deprived of liberty (by judicial or administrative decision)
  • Person who does not speak the French language
  • Absence of affiliation to/Not beneficiary of a Social Security scheme
  • Absence of written informed consent to participate in the study
  • Unable to understand the nature, purpose and methodology of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHM Montpellier

Montpellier, 34090, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

SULTAN Ariane, PU-PH

CONTACT

+33467338402a-sultan@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: We therefore propose a prospective randomised study in 2 arms : * a group of people living with diabetes receiving standard TPE vs * a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

January 9, 2023

Study Start

May 3, 2023

Primary Completion

November 3, 2024

Study Completion

December 3, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

FR(1)