NCT00994357

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes
• Pregnancy

Interventions

Type	Name	Description
DEVICE	Real-time CGM	See previous description.
OTHER	Standard care	See text.

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-10-01
• Completion: 2012-05-01
• First posted: 2009-10-14
• Last updated: 2012-05-09