Biermann 2002.
Study characteristics | ||
Methods |
Are there time and cost savings by using telemanagement for patients on intensified insulin therapy? A randomised, controlled trial Patient RCT (0 clusters and NA providers), conducted in 1) Intervention delivered at the Institute for Diabetes Research in Munich, Germany. 2) Intervention delivered by physicians specialised in diabetes and experienced in intensified insulin therapy. In Germany. 2 arms: 1) Control (conventional outpatient care) (control arm) and 2) Intervention (telecare management) (intervention arm) |
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Participants | Control arm N: 18 Intervention arm N: 30, NA, NA Diabetes type: 1 and 2 Mean age: 30.3 ± 13.5 % Male: NR Longest follow‐up: 8 months |
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Interventions |
Control arm: (conventional outpatient care) 1) Patient education 2) Promotion of self‐management Intervention arm: (telecare management) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management |
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Outcomes | Glycated haemoglobin | |
Funding source | This work was supported by the MediSense/ Abbott Co., Wiesbaden, Germany | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Similar age, duration of diabetes and distance from diabetes centre. |
Patient's baseline outcomes (selection bias) | Low risk | HbA1c of 8.0% for the control group and of 8.3% for the intervention group at baseline. Nothing reported in text about possible difference. |
Incomplete outcome data (attrition bias) | Unclear risk | Sample size in each arms unbalanced (30 participants in the intervention group and 16 in the control). Both intention‐to‐treat and per‐protocol analysis should be done when evaluating the equivalence of an intervention compared to standard practices. Nothing about the number of patients who completed the study. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective outcome (HbA1c). |
Selective reporting (reporting bias) | Unclear risk | No registered protocol or previously published protocol. No SD data provided for HbA1c levels. Results match methods. |
Risk of contamination (other bias) | Low risk | Only the intervention arm used telecare and received call from a specialised physician. Both groups received frequent advice from a health professional about insulin titration either by phone (intervention group) or in‐person (control group). |
Other bias | Unclear risk | The paper lacks details. |