Diabetes mellitus
Conditions
Interventions
The study includes patients registered at outpatient diabetes clinics at General Hospital, Sri Jayewardenepura.
Participants will be allocated into the study arms using simple randomization.
Recruit
Sponsors
Department of Medicine, Faculty of Medicine, University of Kelaniya
Eligibility
Inclusion criteria
Inclusion criteria: Patients comply with following criteria will be recruited 1. A diagnosis of diabetes (Type 1, Type 2 or unspecified). 2. Age 18-80. 3. HbA1c above 8%. 4. Having fluctuations in blood glucose (standard deviation 60 mg/ dl and above). 5. Duration of diabetes over one year. 6. Must own a mobile device that supports Android or iOS (iPhone Operating System) applications. 7. Agreed with study protocol and able to give a written consent for the study.
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Patients on haemodialysis 3. Steroid induced diabetes 4. Inability to be compliant with the study protocol 5. Presence of cognitive impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of the smart phone-based diabetes management application, SGM on overall control of diabetes mellitus 1.1. Improvement of glycaemic control as determined by HbA1c. 1.2. Number of harmful blood glucose fluctuations according to pre-determined criteria using a questionnaire [At baseline and every 12 weeks for a total of 52 weeks.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of SGM on blood glucose levels, lipid profile and occurrence and progression of complications such as dyslipidemia, nephropathy, neuropathy, and micro-vascular complications by following biochemical and physical investigations. 1 Lipid panel (Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides) 2 Fasting blood glucose. 3 Comprehensive Metabolic panel (Alkaline phosphatase, ALT, AST, Blood urea nitrogen, Potassium, Sodium, Calcium, Chloride, Creatinine, Albumin, Total protein). 4 Urine for micro albumin. 5 Foot examination. • Clinical examination by a medical officer/ nursing officer trained in podiatry (inspect for foot ulcers, callus formation, fungal infection) • Monofilament testing for peripheral sensation. • Ankle Brachial Pressure Index measurement with the Doppler device 6 Dilated eye examination [At baseline and every 12 weeks for a total of 52 weeks.] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. Shaluka Jayamanne
Consultant Physician, Senior Lecturer in Medicine
Outcome results
None listed