Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
History of Changes
  Purpose
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.

Condition Intervention
Diabetes
Pregnancy
 Device: Real-time CGM
Other: Standard care

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Prevalence of LGA in children of diabetic women. [ Time Frame: Obtained shortly after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 154
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
See text.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994357

Sponsors and Collaborators
University of Copenhagen
Investigators
Study Chair: Elisabeth R Mathiesen, M.D. Center for Pregnant Women with Diabetes, Copenhagen University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anna Lilja Secher, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00994357     History of Changes
Other Study ID Numbers: SENSOR-01 
Study First Received: October 13, 2009
Last Updated: May 8, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Copenhagen:
Real-time Continuous Glucose Monitoring
Macrosomia

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 27, 2016