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

Air Liquide Santé International1 site in 1 country24 target enrollmentSeptember 5, 2017

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Air Liquide Santé International
Enrollment: 24
Locations: 1
Primary Endpoint: Relationships between glucose levels and insulin doses
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 5, 2017

End Date

March 6, 2018

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Air Liquide Santé International

Responsible Party

Sponsor

Eligibility Criteria

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.