NCT02587286

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

October 22, 2015

Last Update Submit

January 20, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

mHealthTelemedicineRandomized Controlled TrialGlucose control

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    6 months

Secondary Outcomes (1)

  • Change in HbA1c

    3 months

Other Outcomes (26)

  • BMI

    6 months

  • Blood pressure

    6 months

  • Waist Circumference

    6 Months

  • +23 more other outcomes

Study Arms (2)

Gather app

EXPERIMENTAL

Use of the Gather mHealth diabetes management system

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.

Interventions

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.

Gather app

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 28328396DERIVED

  • 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.

    PMID: 27493133DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sanjiv Shah, MD

    Diabetes Action Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 27, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

posted to clinicaltrials.gov