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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 other diabetes related health components.

Investigation of the Gather mHealth platform on diabeticsâ?? behavior and health outcomes. - NA

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/02/005560
Enrollment
90
Registered
2015-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus Patient

Interventions

Intervention1: Gather Health software: Participants in the intervention group will receive both the Gather Health software and an unlimited data plan free for the duration of the study. They will rece

Sponsors

Gather Health Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Type 2 diabetes mellitus, diagnosis for > 6 months. • Age 18 to 65 years, 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.

Exclusion criteria

Exclusion criteria: • 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 • Any psychiatric illness including psychosis or schizophrenia that will impair the patientâ??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 patientâ??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

MeasureTime frame
The primary endpoint is change in % of HbA1c.Timepoint: The primary endpoint is change in % of HbA1c.

Secondary

MeasureTime frame
1. Treatment behavior: medication adherence, SMBG adherence, BG Control, glycemic variability. 2. Physical and psychosocial outcomes: Mean BG, BP, Lipids, BMI, waist circumference, diabetes self care activities, diabetes distress, self efficacy, depressive symptoms, treatment satisfaction, utilization of health care services. 3. Usability of and satisfaction with the Gather Health system.Timepoint: NA

Countries

India

Contacts

Public ContactDr Chirag Shah

Diabetes Action Center

diabetesaction@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026