Type2 Diabetes
Conditions
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.
Interventions
DEVICEdata collection
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.
Sponsors
APHP
ValoTec
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data collection - Blood glucose levels | 28 days | Patients wear a continuous glucose monitoring patch and record blood glucose level measurements (in mg/dl) over time. |
| Data collection - Number of steps | 28 days | Patients wear an activity tracker that will record their number of steps over time. |
| Data collection - Sleep hours | 28 days | Patients wear an activity tracker that will record their sleep hours (sleep start time and sleep end time) during nighttime. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Data collection - Daily meals information | 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. |
| Data collection - Physical activity information | 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. |
| Data collection - Medical treatment information | 28 days | Patients manually record information their medical treatment in a dedicated smartphone application. Treatment intake times are recorded in the smartphone application. |
Countries
France
Outcome results
None listed