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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Albisser 2007.

Study characteristics
Methods Averting iatrogenic hypoglycaemia through glucose prediction in clinical practice: progress towards a new procedure in diabetes
RCT (NA clusters and NA providers), conducted in 1) Secondary care ‐ the Metabolic Care Center, Greenville, Pennsylvania, United States of America. Telemonitoring via scheduled onscreen reviews. All patients were instructed to self‐measure blood glucose ideally 4 or more times a day and to report all episodes of hypoglycaemia. Clinic visits verified this info. 2) Providers accessed the shared, central database using a custom GUI available from the DDC. According to their workgroup security credentials (username and password), providers had full access to the remote server but were restricted only to the data from their cohort of registered patients. In United States of America
2 arms: 1) Control (absence of predicted glycaemia) (control arm) and 2) Intervention (presence of predicted glycaemia) (intervention arm)
Participants Control arm N: 11
Intervention arm N: 11, NA, NA
Diabetes type: 1
Mean age: 49.7 ± NR
% Male: 63.63
Longest follow‐up: 2 months
Interventions Control arm: (absence of predicted glycaemia)
1) Case management
2) Facilitated relay of clinical information
3) Patient education
4) Promotion of self‐management
Intervention arm: (presence of predicted glycaemia)
1) Case management
2) Electronic patient registry
3) Facilitated relay of clinical information
4) Promotion of self‐management
5) Patient reminders
Outcomes 1) Glycated haemoglobin
2) Harms (hypoglycaemia)
Funding source Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Assignment to either the prediction group or the control group was then by random number generated at the DDC.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk See Table 1, characteristics are balanced between groups.
Patient's baseline outcomes (selection bias) Low risk See Table 1, outcomes are balanced between groups.
Incomplete outcome data (attrition bias) Unclear risk No report of dropout.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Because accuracy in SMBG testing is paramount to reduce errors in the predicted values, each patient’s methodology was reviewed and their accuracy verified at clinic visits.
Selective reporting (reporting bias) Unclear risk No registered protocol. Methods match outcomes.
Risk of contamination (other bias) Low risk Unlikely that control patients were given predictive harms information.
Other bias Low risk None identified