Danish Diabetes Birth Registry 2

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

Pregnancies in women with pre-existing diabetes are considered "high risk" pregnancies, poses daily clinical challenges and in terms of research - a number of unanswered questions. Therefore, the investigators wish to establish a nationwide cohort of pregnancies complicated by pre-existing diabetes - the Danish Diabetes Birth Registry (DDBR2) The DDBR2 registry comprises all types of pre-existing diabetes including T1D, T2D and other types (as MODY), generating a nationwide cohort of mother/partner/children trios with accessible registry-, clinical data and biological biobank samples. This will enable the investigators to use data longitudinally to examine short- and long-term outcomes of pregnancies in women with diabetes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women, age ≥ 18 years

Type 1 diabetes, type 2 diabetes or other types of pre-existing diabetes (e.g., maturity onset diabetes of the young (MODY))

Partners of women fulfilling these inclusion criteria, age ≥ 18 years

Offspring of women fulfilling these inclusion criteria

Disqualifiers

No proficiency in Danish or English to understand oral and written information

Trial population

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 Jan. 2023- 31st Dec. 2027. 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 3 trial groups
Group A: Mothers
Group B: Partners
Group C: Offspring

Trial outcomes

Primary outcomes

1

Maternal glycemic control

Maternal HbA1c (mmol/mol) levels at the end of pregnancy (35 weeks)

Time frame
35 weeks
2

Offspring birthweight

Offspring birthweight (g) adjusted for gestational age and gender (standard deviation score)

Time frame
40 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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