Yaron 2019.
| Study characteristics | ||
| Methods |
A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps RCT (NA clusters and NA providers), conducted in 1) Referral centre for T1D in the Maccabi Heath Care Services, Raanana, Israel; 2) Physicians and study co‐ordinators in Israel 2 arms: 1. Control (conventional care) (control arm) and 2. Intervention (telemedicine) (intervention arm) |
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| Participants | Control arm N: 37 Intervention arm N: 37, NA, NA Diabetes type: 1 Mean age: 44.07 ± 9.48 % Male: 47.76 Longest follow‐up: 12 months |
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| Interventions |
Control arm: (conventional care) 1) Promotion of self‐management Intervention arm: (telemedicine) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Promotion of self‐management |
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| Outcomes | Glycated haemoglobin Harms |
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| Funding source | The study was partially supported by Maccabi Health Services Israel | |
| 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 | The 2 groups did not differ in any of the sociodemographic or clinical characteristics examined. No P values reported. |
| Patient's baseline outcomes (selection bias) | Low risk | Although P values are only reported at baseline for HbA1c (P = 0.07), the rest of the values in Table 1 appear similar. However, a very limited number of outcome measures are reported at baseline. |
| Incomplete outcome data (attrition bias) | High risk | 6 lost in intervention group (16%) and 1 lost in control group (3%), reasons provided in supplementary figure S2. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objectively measured outcomes: HbA1c, hypo/hyperglycaemia recorded when transmitted data met required parameters (< 70 mg/dL or > 300 mg/dL). |
| Selective reporting (reporting bias) | Low risk | Prospectively registered protocol. Outcomes in protocol match those in published report. |
| Risk of contamination (other bias) | Low risk | Only intervention group had access to CareLink system. |
| Other bias | Low risk | No evidence of other bias. |