Home » Trials » SLCTR/2017/005
A study to evaluate the effectiveness of Smart Glucose Manager, a mobile application in the management of diabetes mellitus.
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SLCTR Registration Number
SLCTR/2017/005
Date of Registration
The date of last modification
Jul 19, 2019
Scientific Title of Trial
A study to evaluate the effectiveness of Smart Glucose Manager, a mobile application in the management of diabetes mellitus.
Public Title of Trial
Effectiveness of a mobile application based management in patients with diabetes.
Disease or Health Condition(s) Studied
Diabetes mellitus
Scientific Acronym
ABCD (Application based care in diabetes) Trial
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1192-1527
Any other number(s) assigned to the trial and issuing authority
P/120/09/2016 (ERC: Kelaniya)
What is the research question being addressed?
Would a mobile application be effective in the management of diabetes by improving glycemic control, avoiding undue fluctuations in blood glucose (hyperglycemia and hypoglycemia)?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
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.
Recruited patients in the intervention arm will be given a mobile application, Smart Glucose Manager (SGM) which includes several unique features such as a patient reminder to check blood glucose, take their diabetic medications, inject insulin, eat on time and to do exercises. Patients will be educated on the application at the commencement of the intervention and then every 12 weeks. The application will be tested for a period of one year.
The control group will not receive the SGM application and will receive standard clinic care only.
All patients will be followed up every 12 weeks with follow up clinic visits for a total of 52 weeks.
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
Primary outcome(s)
|
1.
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 outcome(s)
|
1.
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.
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. 6 Dilated eye examination |
[ At baseline and every 12 weeks for a total of 52 weeks. ] |
Target number/sample size
50 (25 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-03-16
Anticipated end date
2018-02-28
Date of first enrollment
2017-03-23
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-09-14
Approval number
P/120/09/2016
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Shaluka Jayamanne
Consultant Physician, Senior Lecturer in Medicine
Department of Medicine, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
Sri Lanka
Tel:0112961119
Mob: 0773014722
Fax: 0112958337
shalukajaya@yahoo.com
Contact Person for Public Queries
Aluth Gedara Sumedha Kalpani
Research Asistant
Department of Medicine, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
Sri Lanka
Tel: 0112961119
Mob: 0768555594
Fax: 0112958337
sgmragama@gmail.com
Primary study sponsor/organization
Department of Medicine, Faculty of Medicine, University of Kelaniya
Thalagolla Road, Ragama
Sri Lanka
Tel: 0112961119
Fax: 0112958337
http://medicine.kln.ac.lk/depts/medicine/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
