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| Name | Class |
|---|---|
| DHL Innovation Center, India | OTHER |
| Diabetes Action Centre | OTHER |
| M.V. Hospital for Diabetes | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gather app | Experimental | Use of the Gather mHealth diabetes management system |
|
| Control | No Intervention | Control group participants will be recruited from the same clinics and will also fit all study inclusion and exclusion criteria. Participants will be recommended to test their BG as per usual care in India. Providers will not contact control group participants between regular visits, though they will respond to queries directed at them in typical fashion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gather app | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | 6 months | |
| Blood pressure | 6 months | |
| Waist Circumference |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjiv Shah, MD | Diabetes Action Centre | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28328396 | Derived | 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. | |
| 27493133 |
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posted to clinicaltrials.gov
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 6 Months |
| Fasting Blood Glucose | 6 Months |
| Lipids | 6 Months |
| Diabetes Self-care activities | 6 Months |
| Self-efficacy | Stanford scale | 6 Months |
| Diabetes Knowledge | Adaptation of RAND measure | 6 Months |
| Medication Adherence | Visual Analog Scale | 6 Months |
| Blood Glucose Testing Adherence | Visual Analog Scale | 6 Months |
| Treatment Satisfaction | Adapted RAND measure | 6 Months |
| Diabetes Distress | PAID-5 | 6 Months |
| mHealth intervention satisfaction | Investigator generated | 6 Months |
| BMI | 3 months |
| Blood pressure | 3 months |
| Waist Circumference | 3 months |
| Fasting Blood Glucose | 3 months |
| Lipids | 3 months |
| Diabetes Self-care activities | 3 months |
| Self-efficacy | Stanford Scale | 3 months |
| Diabetes knowledge | Adapted RAND measure | 3 months |
| Med Adherence | Visual Analog Scale | 3 months |
| BG Testing Adherence | Visual Analog Scale | 3 months |
| Treatment Satisfaction | Adapted RAND measure | 3 months |
| Diabetes Distress | PAID-5 | 3 months |
| mHealth intervention satisfaction | Investigator generated | 3 months |
| 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. |
| D004700 | Endocrine System Diseases |