Peters 1991.
Study characteristics | ||
Methods |
Clinical evaluation of decision support system for insulin‐dose adjustment in IDDM RCT (NA clusters and NA providers), conducted in 1) The study was delivered at the Helbachtal Diabetes Education Centre in Germany. 2) Intervention delivered by an educational team (diabetes educators) or using a computerised algorithm. In Germany. 2 arms: 1. Control (education team recommendations) (control arm) and 2. Intervention (learning memory system‐computerized algorithms) (intervention arm) |
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Participants | Control arm N: 25 Intervention arm N: 25, NA, NA Diabetes type: 1 Mean age: 33.4 ± 10.83 % Male: 45.24 Longest follow‐up: 1.05 months |
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Interventions |
Control arm: (education team recommendations) 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management Intervention arm: (learning memory system‐computerised algorithms) 1) Patient education 2) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Harms |
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Funding source | The design and development of the learning memory system by the Department of Internal Medicine, Medical University of Lübeck, was supported by grants from the Deutsche Forschungsgemeinschaft as a postgraduate scholarship 1986‐1989 (A.P.) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. Patients without exclusion criteria were randomly assigned to an experimental or control group. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Table 2 shows the baseline features of the patients at randomisation, and no significant differences existed between the groups. |
Patient's baseline outcomes (selection bias) | Low risk | Table 2 shows the baseline features of the patients at randomisation, and no significant differences existed between the groups. |
Incomplete outcome data (attrition bias) | High risk | 50 patients entered the study. 4 patients from the experimental group were excluded according to the criteria (2 patients removed the microchip and 2 patients developed acute infectious disease). To avoid imbalance between the 2 groups, 4 patients from the control groups were excluded randomly. They lost a total of 8 patients out of 50 (16%). Reasons not balanced. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Our outcomes of interest were objectively measured (HbA1c and hypoglycaemia: proportion of blood glucose < 3.3 mM). |
Selective reporting (reporting bias) | Unclear risk | No registered protocol. Results match methods. |
Risk of contamination (other bias) | Low risk | The experimental group had the opportunity to discuss every problem, except insulin‐dose adjustments, with the physicians and nurses on the team. They had to determine their insulin dosage by themselves, supported only by the (computer) learning memory system. It would have been unethical from the physicians and the nurses to not help a patient with serious insulin titration problem. |
Other bias | Low risk | None identified. |