Clinical trial NCT04057248: Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
Official title: Digital Self-Management and Health Coaching for Type 2 Diabetes - Impact on Diabetes Clinical and Wellness Indicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: LabStyle Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 14
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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:

1. Two scheduled phone sessions with a Diabetes health coach a month;
2. Ongoing dual communication with the coach using digital communication channels such as chat, SMS and emails
3. 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.

Eligibility criteria: Inclusion Criteria:

To be eligible to participate in this study, a subject must meet all the following criteria:

1. Adults 35 years of age or older
2. Diagnosed type 2 Diabetes
3. HbA1C test taken less than 2 months ago and is equal to or above 8.5%
4. Able to read, write and understand English
5. Have supported smartphone (see appendix C for the full smartphone list) with internet package for their service provider
6. The subject is able and agrees to sign the informed consent form

Exclusion Criteria:

1. Adults with impaired cognition
2. Cohabiting with a participant in the study
3. Have an underlying medical condition (such as kidney disease, hemoglobin variants, anemia) that may provide misleading A1C levels
4. Subject is critically ill
5. Subject has an impairment that prevents him/her from following the study procedures
6. Subject is not using medication that may interfere with the blood glucose measurement
7. HCT level which are outside Dario BGMS declared range (20%-60%)

Primary outcomes:
measure: HbA1C Value at 3 Months From Subject Start of Study Compared to Baseline
timeFrame: During 3 Months
Secondary outcomes:
measure: Cholesterol Value at 3 Months From Subject Start of Study
timeFrame: During 3 months
measure: Weight Value at 3 Months From Subject Start of Study
timeFrame: During 3 months
measure: Triglycerides Value at 3 Months From Subject Start of Study
timeFrame: During 3 months
Other outcomes:
Locations:
city: Feasterville
country: United States
facility: Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
state: Pennsylvania
Study officials:
affiliation: Diabetes and Endocrinology Consultants of Pennsylvania, LLC (Decpa LLC)
name: Alan Schorr, Dr.
role: PRINCIPAL_INVESTIGATOR
References: