Effectiveness of a mobile application based management in patients with diabetes.

Not Applicable

Conditions: Diabetes mellitus

Registration Number: SLCTR/2017/005

Lead Sponsor: Department of Medicine, Faculty of Medicine, University of Kelaniya

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow up complete

Sex: Not specified

Target Recruitment: Not specified

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

1. Pregnancy
2. Patients on haemodialysis
3. Steroid induced diabetes
4. Inability to be compliant with the study protocol
5. Presence of cognitive impairment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of the smart phone-based diabetes management application, SGM on overall control of diabetes mellitus<br><br>1.1. Improvement of glycaemic control as determined by HbA1c.<br>1.2. Number of harmful blood glucose fluctuations according to pre-determined criteria using a questionnaire<br><br> [At baseline and every 12 weeks for a total of 52 weeks.]<br>

Secondary Outcome Measures

Name	Time	Method
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.<br><br><br>1 Lipid panel (Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides)<br><br>2 Fasting blood glucose.<br><br>3 Comprehensive Metabolic panel (Alkaline phosphatase, ALT, AST, Blood urea nitrogen, Potassium, Sodium, Calcium, Chloride, Creatinine, Albumin, Total protein).<br><br>4 Urine for micro albumin.<br><br>5 Foot examination.<br><br>• Clinical examination by a medical officer/ nursing officer trained in podiatry (inspect for foot ulcers, callus formation, fungal infection)<br><br>• Monofilament testing for peripheral sensation. <br><br>• Ankle Brachial Pressure Index measurement with the Doppler device<br><br><br>6 Dilated eye examination<br><br><br> [At baseline and every 12 weeks for a total of 52 weeks.]<br>