Fountoulakis 2015.
Study characteristics | ||
Methods |
Impact and duration effect of telemonitoring on ΗbA1c, BMI and cost in insulin‐treated diabetes mellitus patients with inadequate glycemic control: a randomized controlled study RCT (NA clusters and NA providers), conducted in 1) Setting: outpatient care at the Department of Endocrinology at Athens General Hospital “G. Gennimatas”. 2) Data of telemonitoring group (TG) were transmitted from the glucose‐meters to our computers via modem. Communication with an endocrinologist was achieved via e‐mails and mobile phone text‐messages through integrated software. In Greece. 2 arms: 1. Control (usual outpatient care alone) (control arm) and 2. Intervention (telemonitoring group) (intervention arm) |
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Participants | Control arm N: 39 Intervention arm N: 76, NA, NA Diabetes type: 3 Mean age: 55.27 ± 9.57 % Male: 65.71 Longest follow‐up: 12 months |
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Interventions |
Control arm: (usual outpatient care alone) 1) Patient education Intervention arm: (telemonitoring group) 1) Case management 2) Electronic patient registry 3) Clinician reminder 4) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Harms |
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Funding source | Not reported. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomly assigned (2:1), using random number generator and sealed envelopes, into two groups matched for age, BMI and HbA1c. Protocol: randomisation table created by computer software |
Allocation concealment (selection bias) | Low risk | Patients were randomly assigned (2:1), using random number generator and sealed envelopes (protocol: sealed opaque envelopes), into 2 groups matched for age, BMI and HbA1c. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1, no P values. There were no significant differences regarding age, sex and number of glucose measurements per day between TG and CG at baseline. |
Patient's baseline outcomes (selection bias) | Low risk | Table 1, there were no significant differences regarding BMI between TG and CG at baseline. |
Incomplete outcome data (attrition bias) | Low risk | Figure 1. They lost 4/39 (10.3% lost) patients in the control group, and 6/76 (7.9% lost) in the telemonitoring group. Low and balanced numbers. No reasons provided. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective outcomes (HbA1c using lab method and data for hyperglycaemias and hypoglycaemias were obtained by patient's glucosemeter measurements). |
Selective reporting (reporting bias) | Unclear risk | Retrospectively registered protocol. In the paper, they added frequency of doctor‐to‐patient communication (secondary outcomes). Sub‐groups analysis were planned in the protocol. |
Risk of contamination (other bias) | Low risk | Only the intervention patients had access to the telemonitoring system. However, it is unclear if the endocrinologist involved in the intervention group was part of the endocrinologist's team involved in the care of the control group. |
Other bias | Low risk | No evidence of other risk of bias. |