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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Dario Blood Glucose Monitoring System; Behavioral: CDE

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Feasterville, Pennsylvania, United States, 19047-1845
      • Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital platform and CDE coaching intervention for patients with type 2 Diabetes; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	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.	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,	During 3 months

Collaborators and Investigators

• Sponsor: LabStyle Innovations Ltd.
• Investigators: Principal Investigator: Alan Schorr, Dr., Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 9, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CP-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No