Skip to main content
OpenTrials
Completed

NCT Number: NCT04057248

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)

Feasterville, Pennsylvania, 19047-1845, United States

About this study

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:

  • Two scheduled phone sessions with a Diabetes health coach a month;
  • Ongoing dual communication with the coach using digital communication channels such as chat, SMS and emails
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Dario Blood Glucose Monitoring System

Device

Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform

CDE

Behavioral

Certified Diabetes Educator Sessions

Primary outcomes

  1. HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline

    Time frame: 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 outcomes

  1. Cholesterol Value at 3 Months From Subject Start of Study

    Time frame: 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,

  2. Weight Value at 3 Months From Subject Start of Study

    Time frame: 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.

  3. Triglycerides Value at 3 Months From Subject Start of Study

    Time frame: 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,

Sponsors and collaborators

Lead sponsor

LabStyle Innovations Ltd.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2019
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.