Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.

NCT ID: NCT03436212

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2018-03-06

Brief Summary

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This study aims at describing the glucose level by automated glucose sensors and correlating it with insulin delivery and meals over 14 days in insulin-requiring T2D patients living in real-life conditions.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Continuous Glucose Monitoring (CGM)

DEXCOMG4 device for 14 days

Group Type OTHER

Continuous Glucose Monitoring (CGM)

Intervention Type DEVICE

DEXCOMG4 device

Interventions

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Continuous Glucose Monitoring (CGM)

DEXCOMG4 device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 7.5% ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit)
* Daily insulin requirement ≤ 1.5U/kg/day
* Having been compliant to take pictures of his/her meals and snacks over the 3 days prior to the inclusion visit


* Pregnant or breastfeeding woman
* Comorbidity which, in the investigator's opinion, could jeopardize the study completion
* Patient with difficulties to understand the study procedures or deemed unfit, by the Investigator, to comply with operating instructions of CGM equipment.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Liquide Santé International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves Reznik, MD

Role: STUDY_CHAIR

CHU CAEN

Locations

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CHU de Caen, Service Endocrinologie, Diabétologie

Caen, , France

Site Status

Countries

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France

Other Identifiers

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ALMED-17-001

Identifier Type: -

Identifier Source: org_study_id

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