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

Lauffenburger 2019a.

Study characteristics
Methods Effectiveness of targeted insulin‐adherence interventions for glycemic control using predictive analytics among patients with type 2 diabetes: a randomized clinical trial
RCT (NA clusters and NA providers), conducted in 1) This trial used data from Horizon Blue Cross Blue Shield of New Jersey, Newark, the largest health insurer in New Jersey, United States. 2) Intervention involved tailored telephone by a pharmacist from a pharmacy benefit management company. In United States of America.
3 arms: 1. Control (untargeted, low‐intensity insulin‐adherence Interventions) (control arm) and 2. Intervention 1 (partially targeted, moderate‐intensity insulin‐adherence interventions) (intervention arm), 3. Intervention 2 (highly targeted, high‐intensity insulin‐adherence Interventions) (other arm)
Participants Control arm N: 2000
Intervention arm N: 2000, 2000, NA
Diabetes type: 2
Mean age: 55.9 ± 7.89
% Male: 59.8
Longest follow‐up: 12 months
Interventions Control arm: (untargeted, low‐intensity insulin‐adherence Interventions)
1) Promotion of self‐management
Intervention arm: (partially targeted, moderate‐intensity insulin‐adherence Interventions)
1) Case management
2) Patient education
3) Promotion of self‐management
4) Patient reminders
Intervention arm: (highly targeted, high‐intensity insulin‐adherence Interventions)
1) Case management
2) Patient education
3) Promotion of self‐management
4) Patient reminders
Outcomes Glycated haemoglobin
Harms
Funding source This research was supported by Sanofi
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised by Horizon in a 1:1 ratio to the intervention or usual care group using a random number generator.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1, age and gender at baseline are reported. No information on education. Intervention patients were slightly less likely to be female and slightly more likely to have had a prior stroke/transient ischemic attack.
Patient's baseline outcomes (selection bias) Low risk Baseline HbA1C is reported in Table 1, looks balanced.
Incomplete outcome data (attrition bias) High risk 71% loss in the control group (684‐196/684), 71% loss in the intervention arm (678‐196/678).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objectively measured outcome HbA1c.
Selective reporting (reporting bias) High risk There is a published protocol, but they do not talk about the qualitative outcomes in the protocol. However, they report the qualitative outcomes in the study.
Risk of contamination (other bias) Low risk Control group was not contacted in any way, pharmacists only contacted those in intervention group.
Other bias Low risk No evidence of other bias.