Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
Not Applicable
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Device: Continuous Glucose Monitoring (CGM)
- Registration Number
- NCT03436212
- Lead Sponsor
- Air Liquide Santé International
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Continuous Glucose Monitoring (CGM) Continuous Glucose Monitoring (CGM) DEXCOMG4 device for 14 days
- Primary Outcome Measures
Name Time Method Relationships between glucose levels and insulin doses 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU de Caen, Service Endocrinologie, Diabétologie
🇫🇷Caen, France