Short summary

The aim of this study is to establish a new nationwide registry of pregnancies complicated by pre-existing diabetes (mainly type 1 and type 2) - the Danish Diabetes Birth Registry 2 (DDBR2) and to test a novel combined educational intervention in a national randomized controlled trial (RCT): Educational TOolS for pregnant women with Diabetes Mellitus (ETOS-DM) in women with pre-existing diabetes.

Rationale

Pregnancies in women with pre-existing diabetes are still considered "high risk" pregnancies and pose challenges in terms of daily clinical management. Therefore, to explore this risk in a current Danish population, map the influence of both maternal and partner factors on offspring health, improve patient education, comprehend how the intrauterine environment can influence both short- and long-term health of the offspring and to improve pregnancy outcome in women with pre-existing diabetes, we wish to 1) establish a nationwide cohort of pregnancies complicated by pre-existing diabetes - the Danish Diabetes Birth Registry (DDBR2) and 2) test a national educational intervention in a randomized controlled trial: Educational TOolS for pregnant women with Diabetes Mellitus (ETOS-DM)

In the DDBR2 registry we wish to include data on both the woman, her partner and the child, thereby generating a nationwide cohort of mother/partner/children trios with accessible registry data, clinical data and biological samples. This will enable us to use data longitudinally to examine short- and long-term outcomes of pregnancies in women with pre-existing diabetes. The DDBR2 registry will be complimented by an associated genetic, epigenetic and metabolomic interrogation seeking to illuminate possible pathogenic mechanisms that link maternal diabetes to the later life increased risk of lifestyle disease in the offspring as well as a biobank for future research.

The novel combined educational intervention ETOS-DM will be a virtual patient-centered educational tool based on small videos in addition to usual individual face-to face education for pregnant women with pre-existing diabetes. In a national RCT we will evaluate the efficacy of this virtual educational tool in addition to usual individual face-to-face education compared to usual individual face-to face education alone. ETOS-DM builds on the infrastructure and data collection of the DDBR2.

Description of the cohort

DDBR2 is a prospective combined clinical and register-based cohort study including all pregnant women with pre-existing diabetes aged ≥18 years in Denmark, their children and their partners corresponding to ~400 pregnant women each year (250 type 1 diabetes, 150 type 2 diabetes and 5-10 other types), a total of 2000 trios during the inclusion period. The inclusion period is from 1st Mar. 2023- 28th Feb. 2028.

Data and biological material

The registry will include data from electronic patient charts, CGM data, fetal ultra sound data, clinical data, background information on socioeconomic background, online questionnaires and biological samples.

Collaborating researchers and departments

Steno Diabetes Center Odense

• Dorte Møller Jensen

Department of Gynecology and Obstetrics, Odense University Hospital

• Christina Vinter
• Lise Lotte Andersen

Department of Gynecology and Obstetrics, Aarhus University Hospital

• Per Ovesen
• Jens Fuglsang

Steno Diabetes Center Aarhus

• Ulla Kampmann

Center for Pregnant Women with Diabetes, Rigshospitalet

• Elisabeth Mathiesen
• Lene Ringholm
• Peter Damm
• Tine Dalsgaard Clausen

Steno Diabetes Center Copenhagen

• Ulla Bjerre-Christensen

Steno Diabetes Center Sjælland

• Allan Kofoed-Enevoldsen

Department of Gynecology and Obstetrics, Herlev Hospital

• Jeannet Lauenborg

Department of Gynecology and Obstetrics, Aalborg University Hospital

• Anne Sørensen