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

ValoTec

Status: Terminated

Conditions: Type2 Diabetes

Treatments: Device: data collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04155996

VTC-MLS-EC01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

data collection

Description:

20 patients

Treatment:

Device: data collection