Clinical trial NCT02587286: Gather mHealth India RCT for Behavior and Health Outcomes
Official title: Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: mHealth
Telemedicine
Randomized Controlled Trial
Glucose control
Lead sponsor: Gather Health India
Sponsor class: INDUSTRY
Collaborators: name: DHL Innovation Center, India
name: Diabetes Action Centre
name: M.V. Hospital for Diabetes
First posted: 2015-10-27
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this trial is to explore the impact of the Gather Health diabetes management platform diabetics' health behaviors and health outcomes and how providers and diabetics interact with the Gather Health platform.

Detailed description: The overall aim of the study is to estimate the impact of the Gather Health diabetes management platform on HbA1c, glycemic control, patient behavior, and physical and psychosocial measures. Additionally, this study will investigate patient and provider satisfaction with the platform.

Primary Objective:

Estimate the impact of the Gather Health diabetes management platform on HbA1c among diabetics in 3 cities in India.

Secondary Objective:

1. Estimate the impact of the Gather Health diabetes management platform on medication adherence, blood glucose (BG) control, body mass index (BMI), blood pressure (BP), and other behavior and health measures among diabetics in 3 cities in India.
2. Estimate patient and provider's satisfaction with the platform and the perceived usability and time spent on the platform
3. Generate ideas for future changes to the platform to make it more effective and user-friendly

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus, diagnosis for \> 6 months.
* Age 18-65, participants of either gender- males or females.
* HbA1c between 7.5% and 12.5% within last 6 months (inclusive).
* On stable diabetes therapy for \>3 months prior to enrollment.
* Own an Android Smartphone.
* Participant willing to sign and date written Informed Consent Form to participate in the study.
* Willing to comply with the study schedule and procedures including randomization.

Exclusion Criteria:

* Previously used Gather Health
* Currently using an insulin pump or continuous glucose monitor.
* Pregnant or planning to become pregnant in the next 12 months.
* Severe hearing or visual impairment.
* Active substance, alcohol, or drug abuser (sober \<1 year).
* Any psychiatric illness including psychosis or schizophrenia that will impair the patient's ability to complete the study or follow study protocol.
* Recent major surgery or planning to have major surgery
* Significant renal, hepatic, or other disease that may impair patient's ability to complete the study or follow study protocol
* Using glucocorticoids
* Patients who have received or are planning to receive an organ transplant

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 3 months
Other outcomes:
measure: BMI
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Waist Circumference
timeFrame: 6 Months
measure: Fasting Blood Glucose
timeFrame: 6 Months
measure: Lipids
timeFrame: 6 Months
measure: Diabetes Self-care activities
timeFrame: 6 Months
measure: Self-efficacy
timeFrame: 6 Months
measure: Diabetes Knowledge
timeFrame: 6 Months
measure: Medication Adherence
timeFrame: 6 Months
measure: Blood Glucose Testing Adherence
timeFrame: 6 Months
measure: Treatment Satisfaction
timeFrame: 6 Months
measure: Diabetes Distress
timeFrame: 6 Months
measure: mHealth intervention satisfaction
timeFrame: 6 Months
measure: BMI
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: Waist Circumference
timeFrame: 3 months
measure: Fasting Blood Glucose
timeFrame: 3 months
measure: Lipids
timeFrame: 3 months
measure: Diabetes Self-care activities
timeFrame: 3 months
measure: Self-efficacy
timeFrame: 3 months
measure: Diabetes knowledge
timeFrame: 3 months
measure: Med Adherence
timeFrame: 3 months
measure: BG Testing Adherence
timeFrame: 3 months
measure: Treatment Satisfaction
timeFrame: 3 months
measure: Diabetes Distress
timeFrame: 3 months
measure: mHealth intervention satisfaction
timeFrame: 3 months
Locations:
Study officials:
affiliation: Diabetes Action Centre
name: Sanjiv Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Improved Medication Adherence and Frequency of Blood Glucose Self-Testing Using an m-Health Platform Versus Usual Care in a Multisite Randomized Clinical Trial Among People with Type 2 Diabetes in India. Telemed J E Health. 2017 Sep;23(9):733-740. doi: 10.1089/tmj.2016.0265. Epub 2017 Mar 6.
citation: Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Impact of the Gather mHealth System on A1C: Primary Results of a Multisite Randomized Clinical Trial Among People With Type 2 Diabetes in India. Diabetes Care. 2016 Oct;39(10):e169-70. doi: 10.2337/dc16-0869. Epub 2016 Aug 4. No abstract available.