Table 1.
MDMS | STUDY PERIOD—12 Months | |||
Consent | Allocation | Post-allocation | Close-out | |
TIMEPOINT | Baseline | 6 months | 12 months | |
ENROLMENT: | ||||
Eligibility screen | X | |||
Informed consent | X | |||
Allocation | X | |||
INTERVENTION: MDMS | ||||
ASSESSMENTS: | ||||
HbA1c # | X | X | X | |
Blood pressure, Body Mass Index, Lipid profile | X | X | X | |
Patient satisfaction survey and Diabetes Distress Scale | X | X | X | |
CDE satisfaction survey | X | |||
Health-related Quality-of-Life—Assessment of Quality-of-Life (AQoL-8D) questionnaire | X | X | X | |
Self-reported hypoglycaemic events survey | X | X | ||
Clinic Attendance Rates | ||||
Other Assessments | ||||
Patient Acceptability Survey—Intervention group (SUTAQ) ^ | X | X | ||
Clinic Appointment types | ||||
Cost-estimations for delivery of intervention |
MDMS—Mobile Diabetes Management System; # HbA1c also measured at three months; CDE—Credentialled Diabetes Educator; ^ SUTAQ—Service User Technology Acceptability Questionnaire.