Stone 2012a.
| 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 Care co‐ordination ‐ usual care/CC‐UC (control arm) and 2. Prev Care co‐ordination ‐ care co‐ordination/CC‐CC (intervention arm) |
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| Participants | Control arm N: 29 Intervention arm N: 28 Diabetes type: unclear/not reported Mean age: NR ± NR % Male: NR Longest follow‐up: 6 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.5 (1.2), post 8.8 (1.4) Intervention arm: pre 8.6 (1.1), post 8.7 (1.3) |
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| 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 | Quote: "…using a pseudo random binary sequences generated by the study statistician in Stata, with equal allocation within each initial DiaTel group." |
| Allocation concealment (selection bias) | Unclear risk | Quote: "…using a pseudo random binary sequences generated by the study statistician in Stata, with equal allocation within each initial DiaTel group." |
| 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) | Low risk | Not reported. |
| 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) | Unclear risk | Since not cluster, contamination cannot be ruled out. |
| Other bias | Low risk | None. |