Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT04155996|
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment|
|Type2 Diabetes||Device: data collection|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin|
|Actual Study Start Date :||January 20, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
- Data collection - Blood glucose levels [ Time Frame: 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 [ Time Frame: 28 days ]Patients wear an activity tracker that will record their number of steps over time.
- Data collection - Sleep hours [ Time Frame: 28 days ]Patients wear an activity tracker that will record their sleep hours (sleep start time and sleep end time) during nighttime.
- Data collection - Daily meals information [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 28 days ]
Patients manually record information their medical treatment in a dedicated smartphone application.
Treatment intake times are recorded in the smartphone application.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155996
|Contact: Gary TENDONfirstname.lastname@example.org|
|Contact: Jean-Christophe LOURME, Premail@example.com|
|GH Pitié Salpêtrière Charles Foix||Recruiting|
|Paris, Ile De France, France, 75013|
|Contact: Marine Halbron, PH +33142178263 firstname.lastname@example.org|
|Principal Investigator:||Marine HALBRON, MD||APHP|