Real-Life Home Glucose Monitoring Over 14 Days in T2D Pat... | NCT03436212

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

NCT03436212

Sponsor

Air Liquide Santé International

Status

Completed

Last Update Posted

Sep 16, 2025Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus

Interventions

Continuous Glucose Monitoring (CGM)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2017Actual

Primary Completion Date

Mar 6, 2018Actual

Completion Date

Mar 6, 2018Actual

First Submitted Date

Feb 12, 2018

First Submission Date that Met QC Criteria

Feb 12, 2018

First Posted Date

Feb 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2025

Last Update Posted Date

Sep 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Continuous Glucose Monitoring (CGM)	Other	DEXCOMG4 device for 14 days	Device: Continuous Glucose Monitoring (CGM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous Glucose Monitoring (CGM)	Device	DEXCOMG4 device	Continuous Glucose Monitoring (CGM)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relationships between glucose levels and insulin doses	To describe the relationships between glucose levels and insulin doses between meals and at meal-times in T2D patients using pumps over 14 days.	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Selection criteria:

Type 2 Diabetes diagnosed for at least 5 years
Treated with insulin pump for at least 6 months
7.5% ≤ HBA1c ≤ 10% (last available value dated less than 3 months)
Having given his/her free, express and informed consent to participate to the study

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

Non-selection/Non-inclusion criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yves Reznik, MD	University Hospital, Caen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Caen, Service Endocrinologie, Diabétologie		Caen		14033	France

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000095583	Continuous Glucose Monitoring

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided