Status:
COMPLETED
Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
Lead Sponsor:
LabStyle Innovations Ltd.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35+ years
Phase:
NA
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 wi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
July 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04057248
Start Date
July 9 2018
End Date
June 1 2019
Last Update
June 4 2021
Active Locations (1)
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1
Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
Feasterville, Pennsylvania, United States, 19047-1845