Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435565
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : February 15, 2007
Information provided by:
Rigshospitalet, Denmark

Brief Summary:


The risk of stillbirth and preterm delivery is three times increased among pregnant women with type 1 diabetes compared with healthy pregnant women. Normal blood glucose levels are mandatory in order to prevent these complications. Severe hypoglycemia (requiring assistance from another person) is the decisive limiting factor for obtaining near-normal blood glucose regulation in pregnant women with type 1 diabetes. Severe hypoglycemia occurs in about one third of pregnancies complicated with type 1 diabetes and can result in unconsciousness, traffic accidents and deaths.

Aim: To test the following hypotheses:

  1. Severe hypoglycemia is frequent in pregnancy complicated by type 1 diabetes with the highest incidence in gestational weeks 8-16 and the lowest incidence in gestational weeks 28-34
  2. Predictors for severe hypoglycemia during pregnancy complicated with type 1 diabetes can be identified at the first pregnancy visit
  3. Possible pathophysiological mechanisms include changes in the growth hormone system and in the renin-angiotensin-system during pregnancy


One hundred and eight pregnant women with type 1 diabetes are consecutively and prospectively included. In connection with the clinical control at the first pregnancy visit at week 9 and in gestational weeks 14, 22, 28, 34 and one day postpartum the following tests are carried out:

The patients are asked to answer a validated questionnaire about mild and severe hypoglycemia and hypoglycemia-associated factors such as blood glucose level during hypoglycemia, the degree of awareness, pregnancy-associated nausea and vomiting, insulin type and dose etc. Other medication, exercise habits, coffee- and alcohol intake, smoking and social status will be recorded. In case of severe hypoglycemia a structured interview concerning the episode will be performed within 24 hours. Blood glucose, HbA1c, the degree of insulin resistance and the levels of IGF1, placenta growth hormone and of the renin-angiotensin-system will be monitored.

Condition or disease
Pregnancy Diabetes

Study Type : Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes. Incidence, Risk Markers and Possibilities for Prevention

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female

Inclusion Criteria:

  • Type 1 diabetes
  • Pregnancy before gestational week 14

Exclusion Criteria:

  • Other diseases that might influence the risk of severe hypoglycemia

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435565

Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Lene R Nielsen, MD Rigshospitalet, Denmark Identifier: NCT00435565     History of Changes
Other Study ID Numbers: ringholm
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: February 15, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases