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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Rossi 2013.

Study characteristics
Methods Impact of the "Diabetes Interactive Diary" telemedicine system on metabolic control, risk of hypoglycemia, and quality of life: a randomized clinical trial in Type 1 diabetes
Patient RCT, conducted in 12 Italian diabetes outpatient clinics, Italy
Two arms: 1. Standard care (control arm) and 2. DID (intervention arm)
Participants Control arm N: 64
Intervention arm N: 63
Diabetes type: type 1
Mean age: 36.9 ± 10.5
% Male: NR
Longest follow‐up: 6 months
Interventions Control arm:
1) Facilitated relay of clinical information
2) Patient education
Intervention arm:
1) Facilitated relay of clinical information
2) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SE)
Control arm: pre 8.5 (0.1), post 8.1 (0.1)
Intervention arm: pre 8.4 (0.1), post 7.9 (0.1)
2) SBP, mean mmHg (SE)
Control arm: pre 120.0 (1.3), post 118.0 (1.6)
Intervention arm: pre 119.0 (1.4), post 118.3 (1.6)
3) DBP, mean mmHg (SE)
Control arm: pre 71.5 (1.0), post 71.7 (1.0)
Intervention arm: pre 72.9 (1.0), post 72.2 (1.0)
4) LDL, mean mg/dL (SE)
Control arm: pre 109.1 (3.6), post 114.1 (5.2)
Intervention arm: pre 109.4 (3.7), post 117.6 (5.3)
Funding source The study was supported by an unconditional grant from Sanofi‐Aventis SpA, Milan, Italy. Materials for SMBG (glucose meters, strips, lancets and control solutions) were supplied by LifeScan Inc., Milpitas, CA. Me.Te.Da. s.r.l., San Benedetto del Tronto, Italy, is the software company that developed the DID system.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk They said they used a random list, but do not describe how they generated it.
Allocation concealment (selection bias) Low risk Used central allocation through a telephone call to the co‐ordinating centre.
Patient's baseline characteristics (selection bias) High risk Age (P = 0.04).
Patient's baseline outcomes (selection bias) Low risk Information not available.
Incomplete outcome data (attrition bias) High risk Reasons between arms seem balanced, but ~11% lost to follow‐up in control and ~12.7% in intervention. Authors also state that dropout was not directly related to Diabetes Interactive Diary (DID) intervention.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Primary outcome: HbA1c. Secondary outcomes: BP and LDL. Used standard methods at laboratories.
Selective reporting (reporting bias) Low risk Matches protocol.
Risk of contamination (other bias) High risk Not cluster, and physicians cared for both intervention and control, sending back SMS.
Other bias Low risk Information not available.