NCT04155996TerminatedNot Applicable
Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin
ValoTec1 site in 1 country10 target enrollmentStarted: January 20, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Data collection - Number of steps
Study Overview
Brief Summary
The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetic patient (T2D) with HbA1c ≥ 8% in the month prior to inclusion
- •Patient is treated with oral anti-diabetics and / or analogous combined with basal insulin therapy (1 injection of slow-acting insulin in the evening)
- •Age ≥ 35 years
- •Diabetes diagnosis done over 1 year ago
- •Patient accepting for 2 periods of 14 days spaced at most 3 days to wear a Freestyle glucose meter, a bracelet for measuring physical activity and to log daily life events in a dedicated smartphone application
- •Patient is able to use a smartphone
- •Patient is affiliated to the French health insurance system
Exclusion Criteria
- •Patient has Type 1 diabetes, diabetes secondary to pancreatic pathology, endocrinopathy or iatrogenic diabetes
- •Patient is treated with a rapid-acting insulin
- •Patient has had a severe hypoglycaemia in the year preceding inclusion
- •Patent has a severe renal insufficiency (defined by a Glomerular Filtration Rate below 30 ml/min)
- •Patient has had a myocardial infarction or other life-threatening medical condition in the last 6 months
- •Patient has cognitive disorders or evolutionary psychiatric pathology
- •Pregnant woman or woman likely to be pregnant, breastfeeding woman
- •Patient plans to travel outside europe during the study
- •Patient is participating to another clinical study
Outcomes
Primary Outcomes
Data collection - Number of steps
Time Frame: 28 days
Patients wear an activity tracker that will record their number of steps over time.
Data collection - Blood glucose levels
Time Frame: 28 days
Patients wear a continuous glucose monitoring patch and record blood glucose level measurements (in mg/dl) over time.
Data collection - Sleep hours
Time Frame: 28 days
Patients wear an activity tracker that will record their sleep hours (sleep start time and sleep end time) during nighttime.
Secondary Outcomes
- Data collection - Medical treatment information(28 days)
- Data collection - Daily meals information(28 days)
- Data collection - Physical activity information(28 days)
Investigators
Study Sites (1)
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