The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes

Diabetes Clinical Trial

Official title:

The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes: a Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994357
• Other study ID #: SENSOR-01
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: May 8, 2012
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the effects of Real-time Continuous Glucose Monitoring on severe complications to pregnancy in women with diabetes.

Description:

Pregnancy outcome in women with type 1 or type 2 diabetes is still significantly poorer than in the background population. The prevalence of large fat babies (LGA) is 50% in both types of diabetes, and perinatal death and preterm delivery is 4-7 times higher than in non-diabetic women. These complications are all closely related to non-optimal glycemic control in pregnancy, and improved metabolic control is crucial in our strive for improved pregnancy outcome in these patients.

In 2007, a new generation of "real-time" Continuous Glucose Monitoring (CGM) became available in Denmark. These sensors estimate tissue glucose values automatically and frequently with immediate display of the glucose level. In addition it is possible to set alarms for high and low glucose levels, and the patient can react immediately with changes in diet or insulin dose.

In this trial, 154 patients were randomized to either continuous glucose monitoring at five times in pregnancy in addition to standard care ot to unchanged standard care. The main aim is to evaluate if the use of CGM in pregnancy can reduce the prevalence of LGA from 50 to 30%, but other outcome measurements such as preterm delivery, neonatal disease, hypoglycemia, low grade inflammation and vascular dysfunction, quality of life and self- care are also recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregestational diabetes, type 1 or type 2

• Single intrauterine pregnancy

• At least 18 years old

• Informed consent

Exclusion Criteria:

• Past gestational week 14 at inclusion

• Mental disorders

• Language barriere

• Gemelli

• Diabetic nephropathy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Pregnancy

Intervention

Device:
• Real-time CGM
See previous description.

Other:
• Standard care
See text.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of LGA in children of diabetic women.		Obtained shortly after birth	No
Secondary	Metabolic control in terms of HbA1c, blood sugar measurements and the occurence of severe hypoglycemia in pregnant diabetic patients.		During pregnancy	No
Secondary	Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients.		During pregnancy	No
Secondary	Neonatal disease such as neonatal hypoglycemia, respiratory distress and the occurrence of malformations in children of diabetic mothers.		Shortly after birth	No
Secondary	The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes.		During pregnancy	No