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

Stone 2012b.

Study characteristics
Methods The diabetes telemonitoring study extension: an exploratory randomized comparison of alternative interventions to maintain glycemic control after withdrawal of diabetes home telemonitoring
Patient RCT, conducted in 3 VA Pittsburgh Healthcare System hospitals and 5 affiliated community‐based outpatient clinics in Pennsylvania and Ohio, USA
Two arms: 1. Prev Active Care Management ‐ lower‐intensity care co‐ordination/ACM‐CC (control arm) and 2. Prev Active Care Management ‐ care co‐ordination with continued home telemonitoring/ACM‐CCHT (intervention arm)
Participants Control arm N: 21
Intervention arm N: 23
Diabetes type: unclear/not reported
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 6 months
Interventions Control arm:
1) Case management
Intervention arm:
1) Case management
2) Facilitated relay of clinical information
3) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.0 (1.4), post 8.2 (1.0)
Intervention arm: pre 7.8 (0.8), post 8.0 (1.0)
Funding source This work was supported by award W81XWH‐04‐2‐0030 from the US Air Force, administered by the US Army Medical Research Acquisition Activity, Fort Detrick, Maryland, and by resources and the use of facilities at the VA Pittsburgh Healthcare System. A portion of the telemonitoring and other equipment costs were supported by Viterion TeleHealthcare, LLC; Tarrytown, New York. 
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not clearly reported…"reassigned randomly."
Allocation concealment (selection bias) Unclear risk Information not available.
Patient's baseline characteristics (selection bias) Unclear risk Do not provide P values for baseline values.
Patient's baseline outcomes (selection bias) Unclear risk Do not provide P values for baseline outcome values.
Incomplete outcome data (attrition bias) High risk Per‐protocol analysis, 2 missing in N1 group to follow‐up, baseline based on those analysed.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Quote: "Staff involved in the collection of laboratory data was blinded to randomization group."
HbA1c methods not described.
Selective reporting (reporting bias) High risk Information not available.
Risk of contamination (other bias) High risk Quote: "…potential carry‐over effects from the patient education and medication management in the initial DiaTel study…"
Other bias Low risk None.