- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03436212
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. (CLOSE)
February 12, 2018 updated by: Air Liquide Santé International
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
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Renaud Mougenot
- Phone Number: +33 1 39 07 20 68
- Email: renaud.mougenot@airliquide.com
Study Contact Backup
- Name: Guila Lancman
- Phone Number: +33 1 39 07 62 86
- Email: guila.lancman@airliquide.com
Study Locations
-
-
-
Caen, France, 14033
- Recruiting
- CHU de Caen, Service Endocrinologie, Diabétologie
-
Contact:
- Yves Reznik, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Continuous Glucose Monitoring (CGM)
DEXCOMG4 device for 14 days
|
DEXCOMG4 device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yves Reznik, MD, CHU Caen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2017
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 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 (Actual)
February 19, 2018
Last Update Submitted That Met QC Criteria
February 12, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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