Health Condition 1: null- Type 2 Diabetes Mellitus Patient
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| The primary endpoint is change in % of HbA1c.Timepoint: The primary endpoint is change in % of HbA1c. | — |
Secondary
| Measure | Time 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
Diabetes Action Center