Each subject enrolled in the study will be requested to complete an intake questionnaire including diabetes quality of life questions. The subject will use Dario Blood glucose monitoring system and will be contacted by a Certified Diabetes Educator (CDE) two to three times a month as well as have a direct communication using other communication channels such as mail, chat and text messaging (SMS) for lifestyle and diabetes management coaching for a total duration of three months. In the end of study, the subject will complete a diabetes quality of life questionnaire and have a blood test to evaluate its clinical parameters.
This study is designed to assess the effect of digital self-monitoring platform used with the remote support of a Health coach on clinical outcomes and Diabetes quality of life. Study design will be an open-label randomized trial of adults with Type 2. Patients are recruited through the Diabetes and Endocrinology Consultants center setting. Upon randomization to the intervention group, study participants will receive three months diabetes health coaching comprising of: 1. Two scheduled phone sessions with a Diabetes health coach a month; 2. Ongoing dual communication with the coach using digital communication channels such as chat, SMS and emails 3. Diabetes education, behavior modification, goal setting and reinforcement. The Dario App will record participant's glucose measurements and additional information captured by the patient such as medication intake, food and physical activity results. The coach will get access to the patients' App captured information and will intervene ad necessary in the context of the clinical information.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
Certified Diabetes Educator Sessions
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
Feasterville, Pennsylvania, United States
HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline
Change of HbA1C taken in blood test 3 month from the subject start of the study. Data was compared to baseline and reporting the HbA1C change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs.
Time frame: During 3 Months
Cholesterol Value at 3 Months From Subject Start of Study
Change of Cholesterol taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Cholesterol change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs,
Time frame: During 3 months
Weight Value at 3 Months From Subject Start of Study
Change of Weight taken in the clinic at the beginning of the study and 3 month from the subject start of the study Data was compared to baseline and reporting the weight change from baseline measurement and 3 months after subject start of the clinical study.
Time frame: During 3 months
Triglycerides Value at 3 Months From Subject Start of Study
Change of Triglycerides taken in blood test 3 month from the subject start of the study Data was compared to baseline and reporting the Triglycerides change from baseline measurement and 3 months after subject start of the clinical study. Measurement was conducted by Quest labs,
Time frame: During 3 months
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