Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators

Not Applicable

Completed

Interventions: Device: Dario Blood Glucose Monitoring System
Behavioral: CDE

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all the following criteria:

Adults 35 years of age or older
Diagnosed type 2 Diabetes
HbA1C test taken less than 2 months ago and is equal to or above 8.5%
Able to read, write and understand English
Have supported smartphone (see appendix C for the full smartphone list) with internet package for their service provider
The subject is able and agrees to sign the informed consent form

Exclusion Criteria

Adults with impaired cognition
Cohabiting with a participant in the study
Have an underlying medical condition (such as kidney disease, hemoglobin variants, anemia) that may provide misleading A1C levels
Subject is critically ill
Subject has an impairment that prevents him/her from following the study procedures
Subject is not using medication that may interfere with the blood glucose measurement
HCT level which are outside Dario BGMS declared range (20%-60%)

Arm && Interventions

Group	Intervention	Description
Digital platform and CDE coaching intervention for patients with type 2 Diabetes	CDE	Patients provided with digital platform and connected devices. They undergo digital and human (CDE) intervention based on patient captured clinical data. Clinical parameters (HbA1C, weight, lipids profile, etc.) before and after intervention is assessed.
Digital platform and CDE coaching intervention for patients with type 2 Diabetes	Dario Blood Glucose Monitoring System	Patients provided with digital platform and connected devices. They undergo digital and human (CDE) intervention based on patient captured clinical data. Clinical parameters (HbA1C, weight, lipids profile, etc.) before and after intervention is assessed.

Primary Outcome Measures

Name	Time	Method
HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline	During 3 Months	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.

Secondary Outcome Measures

Name	Time	Method
Cholesterol Value at 3 Months From Subject Start of Study	During 3 months	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,
Weight Value at 3 Months From Subject Start of Study	During 3 months	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.
Triglycerides Value at 3 Months From Subject Start of Study	During 3 months	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,