Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Device: data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| data collection<br>20 patients | Device: data collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection - Blood glucose levels | 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 | Patients wear an activity tracker that will record their number of steps over time. | 28 days | 
| Data collection - Sleep hours | 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 | 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 | 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 | Patients manually record information their medical treatment in a dedicated smartphone application. Treatment intake times are recorded in the smartphone application. | 28 days |