NCT04057248

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: LabStyle Innovations Ltd. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Dario Blood Glucose Monitoring System	Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
BEHAVIORAL	CDE	Certified Diabetes Educator Sessions

Timeline

• Start date: 2018-07-09
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2019-08-15
• Last updated: 2021-06-04
• Results posted: 2021-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study