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

Type 2 Diabetes Mellitus Clinical Trial

— CLOSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03436212
• Other study ID #: ALMED-17-001
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2018
• Last updated: February 12, 2018
• Start date: September 5, 2017
• Est. completion date: March 2018

Study information

• Verified date: January 2018
• Source: Air Liquide Santé International
• Contact: Renaud Mougenot
• Phone: +33 1 39 07 20 68
• Email: renaud.mougenot[@]airliquide.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitoring (CGM)
DEXCOMG4 device

Locations

Country	Name	City	State
France	CHU de Caen, Service Endocrinologie, Diabétologie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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