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

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04155996
• Other study ID #: VTC-MLS-EC01
• Status: Terminated
• Start date: January 20, 2019
• Est. completion date: December 4, 2020

Study information

• Verified date: March 2022
• Source: ValoTec
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 4, 2020
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Device:
• data 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.

Locations

Country	Name	City	State
France	GH Pitié Salpêtrière Charles Foix	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
ValoTec	APHP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Data collection - Number of steps	Patients wear an activity tracker that will record their number of steps over time.	28 days
Primary	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	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
Secondary	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
Secondary	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