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

Hsu 2016.

Study characteristics
Methods Utilization of a cloud‐based diabetes management program for insulin initiation and titration enables collaborative decision making between healthcare providers and patients
RCT (NA clusters and NA providers), conducted in 1) The recruitment took place in a tertiary diabetes centre in Massachusetts with care provided by teams of endocrinologists, nurse practitioners, and certified diabetes educators. 2) Intervention group received additional care through the cloud‐based diabetes management program. Intervention facilitates collaborative care between patients and healthcare providers (HCPs). In United States of America.
2 arms: 1. Control (standard tertiary care) (control arm) and 2. Intervention (cloud‐based diabetes management program) (intervention arm)
Participants Control arm N: 20
Intervention arm N: 20, NA, NA
Diabetes type: 2
Mean age: 53.6 ± 10.76
% Male: NR
Longest follow‐up: 3.23 months
Interventions Control arm: (standard tertiary care)
Intervention arm: (cloud‐based diabetes management program)
1) Electronic patient registry
2) Clinician education
3) Facilitated relay of clinical information
4) Patient education
5) Promotion of self‐management
Outcomes Glycated haemoglobin
Harms
Funding source Sponsor: Joslin Diabetes Center
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported. Study participant was randomly assigned to the intervention or the control group.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. All P values above 0.05. The baseline characteristics between the control and the intervention groups were comparable in age, weight, height, body mass index, diabetes duration, initial insulin dose, number of non–insulin antidiabetes agents, and DTSQ score (Table 1).
Patient's baseline outcomes (selection bias) Low risk Table 1. All P values above 0.05. No significant differences were observed for baseline HbA1c.
Incomplete outcome data (attrition bias) High risk 20 participants were randomised to the intervention group versus 20 to the control group. 5 participants (1 from the intervention group (5%) and 4 from the control group (20%) dropped out from the study. Unbalanced numbers. Specifically, 3 failed to show up at the final visit (1 from the intervention group and 2 from the control group), and 2 opted to participate in a medically supervised weight loss programme, which was not part of the study protocol.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk The primary outcome is objective: HbA1c (laboratory method). Hypoglycaemia was subjective in the control group (reviewing the participants’ medical records: participants who either called following an episode or reported hypoglycaemia at the end visit) and objective in the intervention group (digitally capturing hypoglycaemic glucose readings).
Selective reporting (reporting bias) Unclear risk Prospectively registered protocol (protocol first posted on October 2012, study started at the same time). In the paper, they added these outcomes: glucose readings, weight, final insulin dose, mean number of text and video messages sent, common themes emerging from the exit interviews.
Risk of contamination (other bias) Low risk Participants in the control group received standard care at the clinic in initiating and titrating insulin, with interim face‐to‐face visits, as well as telephone/fax communication with educators and physicians as dictated by their HCPs.
Other bias Low risk None.