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CompletedNCT00435565Updated Feb 15, 2007

Severe Hypoglycemia in Pregnant Women With Type 1 Diabetes

An observational study in Pregnancy and Diabetes, sponsored by Rigshospitalet, Denmark. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2007-02-15.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Defined population
Time perspective
Prospective
Sex
Female
01

Study summary

Background:

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

Methodology:

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.

02

Conditions studied

  • Pregnancy
  • Diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

Browse Diabetes Mellitus studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female

Inclusion criteria

  • Type 1 diabetes
  • Pregnancy before gestational week 14

Exclusion criteria

Exclusion Criteria:

  • Other diseases that might influence the risk of severe hypoglycemia
05

Study design

Observational model
Defined population
Time perspective
Prospective
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00435565
Lead sponsor
Rigshospitalet, Denmark
First posted
Feb 15, 2007
Last update
Feb 15, 2007

Study contacts

Lene R Nielsen, MD
principal investigator · Rigshospitalet, Denmark
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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