Yu 2019.
Study characteristics | ||
Methods |
Effects of mobile phone application combined with or without self‐monitoring of blood glucose on glycemic control in patients with diabetes: a randomized controlled trial RCT (NA clusters and NA providers), conducted in 1) Outpatient Department of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China 2) Certified clinicians. In China. 4 arms: 1. Control (no mobile app (MPA) or self‐monitored blood glucose (SMBG) (control arm) and 2. Intervention (SMBG only) (intervention arm), 3. Intervention (MPA only) (other arm), 4. Intervention (MPA and SMBG) (other arm) |
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Participants | Control arm N: 47 Intervention arm N: 45, 48, 45 Diabetes type: 2 Mean age: 52.53 ± 10.49 % Male: 62.16 Longest follow‐up: 5.52 months |
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Interventions |
Control arm: arm (no mobile app (MPA) or self‐monitored blood glucose (SMBG)) Intervention arm: (SMBG only) 1) Promotion of self‐management Intervention arm: (MPA only) 1) Case management 2) Electronic patient registry 3) Clinician reminder 4) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management 7) Patient reminders |
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Outcomes | Glycated haemoglobin Harms |
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Funding source | This study was funded by Key Specialty Construction Project of Pudong Health and Family Planning Commission of Shanghai (Grant No. PWZz2017‐12) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation sequence was created by Stata software version 12.0 (StataCorp, College Station, TX, USA). |
Allocation concealment (selection bias) | Low risk | One staff not associated with the clinical work of the study generated the randomisation sequence and prepared the sequentially numbered, opaque envelopes independently. |
Patient's baseline characteristics (selection bias) | Low risk | See Table 1. P values < 0.05 for age. |
Patient's baseline outcomes (selection bias) | Unclear risk | See Table 1. P values < 0.05 for DBP and total cholesterol. |
Incomplete outcome data (attrition bias) | High risk | 6 lost in control (13%), 7 lost in SMBG only group (16%), 5 lost in MPA only group (10%) and 7 lost in MPA and SMBG group (16%). Reasons reported. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Objectively measured outcomes: HbA1c; we think hypoglycaemic events (≤ 3.9 mmol/L) were self‐reported. |
Selective reporting (reporting bias) | Low risk | Prospectively registered. All outcomes reported. |
Risk of contamination (other bias) | Low risk | Groups may have been followed by same physicians; however, MPA and blood glucose monitors were only offered to the appropriate intervention groups. |
Other bias | Low risk | No evidence of other bias. |