CTRI/2022/06/043130
Completed
N/A
An Observational Study to Assess the Effect of the Accu-Chek® SugarView app (based on app version 4.0.3) on Diabetes Empowerment of Subjects with Type 2 Diabetes Mellitus (BEAT Accu-Chek SugarView India Study)
Roche Diabetes Care India Pvt Ltd0 sites100 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Sponsor
- Roche Diabetes Care India Pvt Ltd
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject has provided his/her signed informed consent.
- •2\. Subject is \= 18 years of age
- •3\. Subject is diagnosed with diabetes type 2 and currently on exercise, diet or single or dual agent anti\-diabetic therapy (but not on insulin and anti\-diabetic drug with an hypoglycemic risk profile such as sulfonylureas)
- •4\. Need to be empowered for disease self\-management
- •5\. Willingness to adhere to the app
- •\- Never used a blood glucose meter for self\-testing of blood glucose before (SMBG naive)
- •6\. Subject must have and can use a smartphone, and should complete training on usage of the application installed in smartphone
- •7\. Subjects who are able to read and write in English language
- •8\. Willing to participate in the study and comply with study procedures
- •9\. Provide study demographics such as age, education level, gender, therapy type and occupation
Exclusion Criteria
- •1\. Subject is pregnant or breastfeeding
- •2\. Subject has incarceration or vision impairment not correctable with glasses or contact lenses
- •3\. Subject is diagnosed with any clinically significant condition (e.g. infectious disease,
- •major organ system disease, such as gastroparesis or renal disease, psychosis or cognitive impairment), at investigator’s discretion
- •4\. Subject does undergo chemotherapy or radiation therapy (self\-reported)
- •5\. Subject is related to the investigator or research staff
- •6\. Subject is using any other mobile device to monitor glucose levels
- •7\. Subject shares phones with other persons
Outcomes
Primary Outcomes
Not specified
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