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.
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus Patient
- Registration Number
- CTRI/2015/02/005560
- Lead Sponsor
- Gather Health Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
• 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.
•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 <1year).
• 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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is change in % of HbA1c.Timepoint: The primary endpoint is change in % of HbA1c.
- Secondary Outcome Measures
Name Time Method 1. Treatment behavior: medication adherence, SMBG adherence, BG Control, glycemic variability. <br/ ><br>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. <br/ ><br>3. Usability of and satisfaction with the Gather Health system.Timepoint: NA