Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT04057248
- Run by
- LabStyle Innovations Ltd.
- People needed
- 14
- Starts
- 2018-07-09
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2021-06-04
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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%)
Where it is running
- Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC) — Feasterville, Pennsylvania, United States
Full record on ClinicalTrials.gov
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