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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitoring (CGM)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CHU de Caen, Service Endocrinologie, Diabétologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous Glucose Monitoring (CGM); DEXCOMG4 device for 14 days	Device: Continuous Glucose Monitoring (CGM); DEXCOMG4 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Investigators: Study Chair: Yves Reznik, MD, CHU caen

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): March 6, 2018
• Study Completion (Actual): March 6, 2018

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: ALMED-17-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No