The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes: a Randomised Controlled Study|
- Prevalence of LGA in children of diabetic women. [ Time Frame: Obtained shortly after birth ] [ Designated as safety issue: No ]
- Metabolic control in terms of HbA1c, blood sugar measurements and the occurence of severe hypoglycemia in pregnant diabetic patients. [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
- Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients. [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
- Neonatal disease such as neonatal hypoglycemia, respiratory distress and the occurrence of malformations in children of diabetic mothers. [ Time Frame: Shortly after birth ] [ Designated as safety issue: No ]
- The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes. [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Real-time Continuous Glucose Monitoring
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.
Device: Real-time CGM
See previous description.
Active Comparator: Control group
Standard monitoring and treatment of diabetic patients during pregnancy.
Other: Standard care
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994357
|Study Chair:||Elisabeth R Mathiesen, M.D.||Center for Pregnant Women with Diabetes, Copenhagen University Hospital|