- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155996
Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus
Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ile De France
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Paris, Ile De France, France, 75013
- GH Pitié Salpêtrière Charles Foix
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
data collection
20 patients
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Patients will receive a full data acquisition set with CGM sensors, an activity tracker and a smartphone application in which they can log daily events.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days
|
Data collection - Number of steps
Time Frame: 28 days
|
Patients wear an activity tracker that will record their number of steps over time.
|
28 days
|
Data collection - Sleep hours
Time Frame: 28 days
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Patients wear an activity tracker that will record their sleep hours (sleep start time and sleep end time) during nighttime.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Data collection - Daily meals information
Time Frame: 28 days
|
Patients manually record information about meals in a dedicated smartphone application. Each meal size (Small, Medium or Large) and glycemic index (Low, Medium or High) is evaluated by patients in the application. |
28 days
|
Data collection - Physical activity information
Time Frame: 28 days
|
Patients manually record information about physical activities in a dedicated smartphone application. Each physical activity duration (Short, Medium or Long) and intensity (Low, Medium or High) is evaluated by patients in the application. |
28 days
|
Data collection - Medical treatment information
Time Frame: 28 days
|
Patients manually record information their medical treatment in a dedicated smartphone application. Treatment intake times are recorded in the smartphone application. |
28 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VTC-MLS-EC01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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