Go to main content

INTENSE-GDM

​Effect of intensive nutrition training, education, and support versus standard care in reducing the need for insulin therapy in gestational diabetes (INTENSE-GDM): A randomised controlled trial

​A​im

The overall objective is to investigate differences in clinical, cost-related, and patient-reported outcomes between women with gestational diabetes (GDM) randomised to either intensive dietary therapy or standard dietary care.

The primary outcome is to investigate if intensive dietary therapy can reduce the number of women with gestational diabetes (GDM) initiated on insulin therapy without increasing healthcare costs.

Secondary outcomes include a range of clinical health parameters, such as:
  • delaying or reducing the need for insulin
  • limiting weight gain in both the mother and the unborn child
  • improving glycemic control in the mother during pregnancy
Additionally, the trial aims to examine diet-related quality of life, well-being, treatment satisfaction, perceived support for autonomy, and competencies related to diet and diabetes. 

Study design

Randomised controlled trial​.

Collaborators

  • Obstetricians, midwifes, and nurses at Dept. Obstetrics, Herlev-Gentofte University Hospital
  • Endocrinologists at Steno Diabetes Center Copenhagen
  • Center for Pregnant Women with Diabetes, Dept. Endocrinology, Rigshospitalet.

Funding

Financed by internal funding at SDCC.

Study period

January 2024 - June 2025.




Updated on 2 January 2024.

Last updated:
Responsible editor
Klik for at scrolle op eller ned p� siden G� til toppen af siden