search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous Glucose Monitoring (CGM)
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Caen, Service Endocrinologie, DiabétologieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Continuous Glucose Monitoring (CGM)

Arm Description

DEXCOMG4 device for 14 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2018
Last Updated
February 12, 2018
Sponsor
Air Liquide Santé International
search

1. Study Identification

Unique Protocol Identification Number
NCT03436212
Brief Title
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
Acronym
CLOSE
Official Title
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. The CLOSE Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Glucose Monitoring (CGM)
Arm Type
Other
Arm Description
DEXCOMG4 device for 14 days
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring (CGM)
Intervention Description
DEXCOMG4 device
Primary Outcome Measure Information:
Title
Relationships between glucose levels and insulin doses
Description
To describe the relationships between glucose levels and insulin doses between meals and at meal-times in T2D patients using pumps over 14 days.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renaud Mougenot
Phone
+33 1 39 07 20 68
Email
renaud.mougenot@airliquide.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guila Lancman
Phone
+33 1 39 07 62 86
Email
guila.lancman@airliquide.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Reznik, MD
Organizational Affiliation
CHU Caen
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Caen, Service Endocrinologie, Diabétologie
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Reznik, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs