Gestational diabetes & diabetes in pregnancy

Efficacy of a Digital Diabetes Logbook for People With Type 1, Type 2, and Gestational Diabetes: Results From a Multicenter, Open-Label, Parallel-Group, Randomized Controlled Trial

J Diabetes Sci TechnolPublished Randomised controlled trial

Primary result · Reduction in diabetes distressResult — go to the resultModel-based adjusted between-group difference −2.20 CI −4.02 to −0.38

Authors' conclusion

The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.

Study context

Population
People with T1D, T2D or GDM with regular SMBG, 41 sites in Germany397 completed
Participants
424 people
Comparison
Digital diabetes logbook vs no app use
  • Interventionn = 282
  • Controln = 142reference
Primary endpoint
Reduction in diabetes distress
Follow-up
12-week follow-up
Methodological detailsmulticentre, open-label, parallel-group, 2:1 randomisation
  • Multicentre
  • Open-label
  • Parallel-group
  • 2:1 randomisation

Primary result

As reported in the abstract

12 weeks

Model-based adjusted between-group difference

−2.20

CI −4.02 to −0.38

P = 0.0182

Change by group

Intervention

2.41

median · IQR −2.50–8.11

Control

1.25

median · IQR −5.00–7.50

Interventionvs Control
model-based adjusted between-group difference −2.20 (CI −4.02 to −0.38); P = 0.0182

Safety

Adverse events

Adverse events — Total adverse events
27

Original publication

Efficacy of a Digital Diabetes Logbook for People With Type 1, Type 2, and Gestational Diabetes: Results From a Multicenter, Open-Label, Parallel-Group, Randomized Controlled Trial. J Diabetes Sci Technol. Published 26 March 2024. doi:10.1177/19322968241239870

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