Diabetes Mellitus, Type 2NCT02587286
Gather mHealth India RCT for Behavior and Health Outcomes
A study testing Gather app in people with Diabetes Mellitus, Type 2, run by Gather Health India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Gather app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.
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.
Read the 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:
- 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.
- Estimate patient and provider's satisfaction with the platform and the perceived usability and time spent on the platform
- Generate ideas for future changes to the platform to make it more effective and user-friendly
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Gather app
- Keywords
- mHealth, Telemedicine, Randomized Controlled Trial, Glucose control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gather appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gather app | Experimental | Use of the Gather mHealth diabetes management system Receives: Other: Gather app |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: 6 months
Secondary outcomes (1)
Change in HbA1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gather Health India
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DHL Innovation Center, India, Diabetes Action Centre, M.V. Hospital for Diabetes
- Responsible party
- Sponsor
- Investigators
- Sanjiv Shah, MD, Principal investigator, Diabetes Action Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587286
- Sponsor's protocol ID
- Gather mHealth 1
- Status last verified
- Jan 2016
- First submitted
- 22 Oct 2015
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: posted to clinicaltrials.gov
Publications
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.
PubMed 28328396Kleinman 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.
PubMed 27493133
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.
- ClinicalTrials.gov ID
- NCT02587286
- Acronym / sponsor ID
- Gather mHealth 1
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- mHealth, Telemedicine, Randomized Controlled Trial, Glucose control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Gather Health IndiaIndustry (pharma, biotech, devices)
- Collaborators
- DHL Innovation Center, India, Diabetes Action Centre, M.V. Hospital for Diabetes
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Estimate patient and provider's satisfaction with the platform and the perceived usability and time spent on the platform
- Generate ideas for future changes to the platform to make it more effective and user-friendly
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gather app | Experimental | Other: Gather appUse 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gather appParticipants 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. | Other | Gather app |
Primary outcome
Change in HbA1c
Time frame: 6 months
1 secondary outcome
Change in HbA1c
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- Derived from this study: PubMed 28328396Kleinman 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.
- Derived from this study: PubMed 27493133Kleinman 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.
- Individual participant dataSharing planned: Yes. posted to clinicaltrials.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjiv Shah, MD principal investigator
Diabetes Action Centre
Questions about this trial
What is this clinical trial studying?
A study testing Gather app in people with Diabetes Mellitus, Type 2, run by Gather Health India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.