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. 2019 May 23;2019(5):CD009613. doi: 10.1002/14651858.CD009613.pub4

Dalfrà 2009.

Methods Quasi‐randomised trial.
Women were sequentially assigned to telemedicine and control groups (not randomised).
Period of study: not reported.
Participants 88 women with gestational diabetes in the telemedicine group and 115 in the control group;
 17 women with type 1 diabetes in the telemedicine group and 15 in the control group.
Inclusion criteria: pregnant women with type 1 diabetes (enrolled in the study at their first visit after conception. Women with gestational diabetes included after a week from the diagnosis of gestational diabetes.
Exclusion criteria: not described.
Interventions Intervention: automated telemedicine monitoring.
Control: conventional system.
Outcomes Outcomes used in this review

  1. Caesarean section.

  2. Neonatal morbidity composite (presence of macrosomia (4000 g) and complications).

  3. Gestational age at birth.

  4. Use of additional insulin therapy.

  5. Glycaemic control (maternal).

  6. Weight gain.

  7. Macrosomia.

  8. Birthweight.
Notes Setting: 12 diabetes clinics.
Country: Italy.
Funding: not mentioned.
Declarations of interest: not reported.
Comments: data for women with gestational diabetes and type 1 diabetes are presented separately.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: “Women were sequentially assigned to two groups: one patient was followed up using the telemedicine approach and the next using the conventional approach (usual care).”
Allocation concealment (selection bias) High risk No attempt was made to conceal allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk No attempt was made to blind women or personnel. Women were aware of whether they were being monitored using telemedicine or usual care. However, the outcomes were measured objectively and would not have been influenced by blinding or not blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No blinding of outcome assessment. However, all outcomes were objectively measured.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 4/36 women with type 1 diabetes and 37/240 women with gestational diabetes were excluded because they did not complete questionnaires at the end of the study. It is unclear whether these were women with type 1 diabetes or gestational diabetes.
Selective reporting (reporting bias) Unclear risk This study was assessed from a published report, without the study protocol. The main outcomes were reported separately for type 1 diabetes and GDM, however some outcomes were not reported separately or were only reported in the text.
Other bias High risk The study did not use an intention‐to‐treat analysis. There is no sample size calculation, or information on whether groups were comparable at baseline. Women with type 1 diabetes only make up a small part of the whole study (32 out of 235 women).