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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Lilja Secher, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00994357
First received: October 13, 2009
Last updated: May 8, 2012
Last verified: May 2012

October 13, 2009
May 8, 2012
February 2009
October 2011   (final data collection date for primary outcome measure)
Prevalence of LGA in children of diabetic women. [ Time Frame: Obtained shortly after birth ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00994357 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Pregnancy
  • Device: Real-time CGM
    See previous description.
  • Other: Standard care
    See text.
  • 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.
    Intervention: Device: Real-time CGM
  • Active Comparator: Control group
    Standard monitoring and treatment of diabetic patients during pregnancy.
    Intervention: Other: Standard care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
May 2012
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00994357
SENSOR-01
No
Anna Lilja Secher, University of Copenhagen
University of Copenhagen
Not Provided
Study Chair: Elisabeth R Mathiesen, M.D. Center for Pregnant Women with Diabetes, Copenhagen University Hospital
University of Copenhagen
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP