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Completed

NCT Number: NCT03436212

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Caen, Service Endocrinologie, Diabétologie

Caen, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous glucose monitoring (CGM)

Device

DEXCOMG4 device

Primary outcomes

  1. Relationships between glucose levels and insulin doses

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Registry information

Official study title

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

Acronym: CLOSE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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