N/A
Completed N=14
Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
Source: ClinicalTrials.gov NCT04057248 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline — 8.2 percentage of HBA1C in blood
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline |
8.2 | — |
| SECONDARY Cholesterol Value at 3 Months From Subject Start of Study |
179.0 | — |
| SECONDARY Weight Value at 3 Months From Subject Start of Study |
230.7 | — |
| SECONDARY Triglycerides Value at 3 Months From Subject Start of Study |
172.0 | — |
Eligibility Criteria
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%)
Data sourced from ClinicalTrials.gov (NCT04057248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.