NCT03436212

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

February 12, 2018

Last Update Submit

September 10, 2025

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Continuous Glucose Monitoring (CGM)

OTHER

DEXCOMG4 device for 14 days

Device: Continuous Glucose Monitoring (CGM)

Interventions

Continuous Glucose Monitoring (CGM)DEVICE

DEXCOMG4 device

Continuous Glucose Monitoring (CGM)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • % ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit)
  • Daily insulin requirement ≤ 1.5U/kg/day
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Caen, Service Endocrinologie, Diabétologie

Caen, 14033, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Yves Reznik, MD

    CHU CAEN

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 19, 2018

Study Start

September 5, 2017

Primary Completion

March 6, 2018

Study Completion

March 6, 2018

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

FR(1)