Diabetes Mellitus, Type 2
Conditions
Keywords
mHealth, Telemedicine, Randomized Controlled Trial, Glucose control
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
Interventions
OTHERGather app
Participants in the intervention group will receive the Gather Health software free for the duration of the study. Their medication and BG testing goals will be entered into the system and they will receive automated reminders. Their data will be regularly reviewed by study staff and feedback provided.
Sponsors
DHL Innovation Center, India
Diabetes Action Centre
M.V. Hospital for Diabetes
Gather Health India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c | 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | 6 Months | — |
| Fasting Blood Glucose | 6 Months | — |
| Lipids | 6 Months | — |
| Diabetes Self-care activities | 6 Months | — |
| Self-efficacy | 6 Months | Stanford scale |
| Diabetes Knowledge | 6 Months | Adaptation of RAND measure |
| Medication Adherence | 6 Months | Visual Analog Scale |
| BMI | 6 months | — |
| Treatment Satisfaction | 6 Months | Adapted RAND measure |
| Diabetes Distress | 6 Months | PAID-5 |
| mHealth intervention satisfaction | 6 Months | Investigator generated |
| Diabetes knowledge | 3 months | Adapted RAND measure |
| Med Adherence | 3 months | Visual Analog Scale |
| BG Testing Adherence | 3 months | Visual Analog Scale |
| Blood Glucose Testing Adherence | 6 Months | Visual Analog Scale |
| Blood pressure | 6 months | — |
Outcome results
None listed