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

Not Applicable

Completed

• Conditions: Diabetes; Pregnancy
• Interventions: Other: Standard care; Device: Real-time CGM

• Registration Number: NCT00994357
• Lead Sponsor: University of Copenhagen

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2011-10
• Status Verified: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard care	Standard monitoring and treatment of diabetic patients during pregnancy.
Real-time Continuous Glucose Monitoring	Real-time CGM	Real-time Continuous Glucose Monitoring at five times for up to 6 days during pregnancy, and during delivery, in addition to standard monitoring and treatment.

Primary Outcome Measures

Name	Time	Method
Prevalence of LGA in children of diabetic women.	Obtained shortly after birth

Secondary Outcome Measures

Name	Time	Method
Metabolic control in terms of HbA1c, blood sugar measurements and the occurence of severe hypoglycemia in pregnant diabetic patients.	During pregnancy
Neonatal disease such as neonatal hypoglycemia, respiratory distress and the occurrence of malformations in children of diabetic mothers.	Shortly after birth
Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients.	During pregnancy
The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes.	During pregnancy