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

10 Mar 2017

The date of last modification

Mar 03, 2019



Application Summary


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)


Trial Details


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

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


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.
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.

]

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


Date of study completion


Recruitment status

Pending


Funding source

None (Investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


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/

Secondary study sponsor (If any)

None





Trial Completion details


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