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

Terminated

• Conditions: Type2 Diabetes
• Interventions: Device: data collection

• Registration Number: NCT04155996
• Lead Sponsor: ValoTec

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-22
• Study Start: 2019-01-20
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Primary Completion: 2020-12-04
• Study Completion: 2020-12-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
data collection	data collection	20 patients

Primary Outcome Measures

Name	Time	Method
Data collection - Number of steps	28 days	Patients wear an activity tracker that will record their number of steps over time.
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 - 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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

GH Pitié Salpêtrière Charles Foix; 🇫🇷 Paris, Ile De France, France