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

A

Air Liquide

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Device: Continuous Glucose Monitoring (CGM)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03436212
ALMED-17-001

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Continuous Glucose Monitoring (CGM)
Other group
Description:
DEXCOMG4 device for 14 days
Treatment:
Device: Continuous Glucose Monitoring (CGM)

Trial contacts and locations

1

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Central trial contact

Guila Lancman; Renaud Mougenot

Data sourced from clinicaltrials.gov

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