ClinicalTrials.gg
CompletedNCT03436212CLOSEUpdated Sep 16, 2025

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

An interventional study of Continuous Glucose Monitoring (CGM) in Type 2 Diabetes Mellitus, sponsored by Air Liquide Santé International. Completed at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Air Liquide Santé International (part of Air Liquide) · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Air Liquide Santé International is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Selection criteria:

  • Type 2 Diabetes diagnosed for at least 5 years
  • Treated with insulin pump for at least 6 months
  • 7.5% ≤ ≤ 10% (last available value dated less than 3 months)
  • Having given his/her free, express and 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Other
    Continuous Glucose Monitoring (CGM)

    DEXCOMG4 device for 14 days

    Device: Continuous Glucose Monitoring (CGM)

Interventions

  • DeviceContinuous Glucose Monitoring (CGM)

    DEXCOMG4 device

06

What researchers measure

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.

    Time frame: 14 days

07

Study locations

1 site
  • CHU de Caen, Service Endocrinologie, Diabétologie
    Caen, 14033, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03436212
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Sep 5, 2017
Primary completion
Mar 6, 2018
Completion
Mar 6, 2018
Last update
Sep 16, 2025

Study contacts

Yves Reznik, MD
study chair · University Hospital, Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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