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

NCT04057248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-06-04

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

  • LabStyle Innovations Ltd.

    lead INDUSTRY

Principal Investigators

  • Alan Schorr, Dr. · Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2019-06-01
Completion
2019-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057248 on ClinicalTrials.gov