Skip to main content
. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Gunawardena 2019.

Study characteristics
Methods The influence of the smart glucose manager mobile application on diabetes management
RCT (NA clusters and NA providers), conducted in 1) The ABCD trial was a randomised clinical trial conducted in collaboration with the faculty of medicine in Kelaniya University and Sri Jayewardenapura Hospital, Sri Lanka. The study includes patients registered at outpatient diabetes clinics at General Hospital, Sri Jayewardenepura. Intervention delivered using a Smart Glucose Manager (SGM) mobile application. 2) The SMBG summary of the SGM group and control groups were reviewed by usual clinic staff. In Sri Lanka.
2 arms: 1. Control (standard methods of diabetes management) (control arm) and 2. Intervention (SGM: Smart Glucose Manager mobile application) (intervention arm)
Participants Control arm N: 32
Intervention arm N: 35, NA, NA
Diabetes type: 4
Mean age: 52 ± 9.33
% Male: 60
Longest follow‐up: 6 months
Interventions Control arm: (standard methods of diabetes management)
Intervention arm: (SGM: Smart Glucose Manager mobile application)
1) Electronic patient registry
2) Facilitated relay of clinical information
3) Promotion of self‐management
4) Patient reminders
Outcomes Glycated haemoglobin
Funding source The author(s) received no financial support for the research, authorship, and/or publication of this article
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Of 300 screened, 67 met eligibility criteria and were randomised, using a computer‐generated random sequence method created by Sealed Envelope Ltd, into either the SGM (n = 35) or control (n = 32) group (Figure 1).
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Baseline participants’ characteristics reported in Table 2. Looks similar.
Patient's baseline outcomes (selection bias) Low risk Table 2. Baseline data for HbA1c reported, looks similar between groups, 
Incomplete outcome data (attrition bias) High risk 67 patients met eligibility criteria and were randomised into either the SGM (n = 35) or control (n = 32) group. Eight patients from the SGM group (8/35 = 23% lost) and 7 from the control group (7/32 = 22% lost) were not able to finish the study. High % lost in both arms.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk HbA1c was objectively measured.
Selective reporting (reporting bias) High risk Prospectively registered protocol. They do not report the second primary outcome listed in the protocol: 1.2. Number of harmful blood glucose fluctuations (hyperglycaemia and hypoglycaemia) according to pre‐determined criteria using a questionnaire. No secondary outcomes are reported in the paper.
Risk of contamination (other bias) Unclear risk Patients randomised from one clinic. Unlikely that control patients had access to the Smart Glucose Manager mobile application. However, usual clinic staff could have changed their approach with control patients after seeing the data generated by the application from the intervention group.
Other bias High risk Protocol: the application will be tested for a period of 1 year. But they only report 6 months data in the paper. Inclusion criteria in the protocol: duration of diabetes over 1 year, but in the paper: self‐reported having diabetes for at least 6 months.