NCT05678543

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jan 2023Dec 2030

First Submitted

Initial submission to the registry

December 16, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

December 16, 2022

Last Update Submit

April 11, 2024

Conditions

Pregnancy in DiabeticType 1 DiabetesType 2 DiabetesParentsFetal ComplicationsMaternal DiabetesBirth InjuriesFamily

Outcome Measures

Primary Outcomes (2)

  • Maternal glycemic control

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

    35 weeks

  • Offspring birthweight

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

    40 weeks

Study Arms (3)

Mothers

Pregnant women with pre existing diabetes.

Partners

Partners to pregnant women with pre existing diabetes.

Offspring

Offspring born to women with pre existing diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • 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))

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dept. of Obstetrics and Gynaecology, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Dept. of Obstetrics and Gynaecology, Aarhus Universitety Hospital

Aarhus, 8200, Denmark

RECRUITING

Center for Pregnant Women with Diabetes, Copenhagen University Hospital , Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Dept. of Obstetrics and Gynaecology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (1)

  • Knorr S, Aalders J, Overgaard M, Stovring H, Mathiesen ER, Damm P, Clausen TD, Bjerre-Christensen U, Andersen LLT, Vinter C, Kofoed-Enevoldsen A, Lauenborg J, Kampmann U, Fuglsang J, Ovesen PG, Christensen TT, Sorensen A, Ringholm L, Jensen DM. Danish Diabetes Birth Registry 2: a study protocol of a national prospective cohort study to monitor outcomes of pregnancies of women with pre-existing diabetes. BMJ Open. 2024 Apr 25;14(4):e082237. doi: 10.1136/bmjopen-2023-082237.

    PMID: 38670616DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Se project description

MeSH Terms

Conditions

Pregnancy in DiabeticsDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes, GestationalBirth Injuries

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Officials

  • Dorte M Jensen, Prof.

    Steno Diabetes Center Odense

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sine K Johnsen, PhD

CONTACT

+45 78 45 54 85sine.knorr@clin.au.dk

Dorte M Jensen, Prof.

CONTACT

Dorte.Moeller.Jensen@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 10, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations

DK(4)