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

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ClinicalTrials.gov Identifier: NCT00994357
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : May 9, 2012
Sponsor:
Information provided by (Responsible Party):
Anna Lilja Secher, University of Copenhagen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Pregnancy Device: Real-time CGM Other: Standard care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of LGA in children of diabetic women. [ Time Frame: Obtained shortly after birth ]

Secondary Outcome Measures :
  1. Metabolic control in terms of HbA1c, blood sugar measurements and the occurence of severe hypoglycemia in pregnant diabetic patients. [ Time Frame: During pregnancy ]
  2. Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients. [ Time Frame: During pregnancy ]
  3. Neonatal disease such as neonatal hypoglycemia, respiratory distress and the occurrence of malformations in children of diabetic mothers. [ Time Frame: Shortly after birth ]
  4. The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes. [ Time Frame: During pregnancy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994357


Sponsors and Collaborators
University of Copenhagen
Investigators
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Study Chair: Elisabeth R Mathiesen, M.D. Center for Pregnant Women with Diabetes, Copenhagen University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anna Lilja Secher, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00994357    
Other Study ID Numbers: SENSOR-01
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012
Keywords provided by Anna Lilja Secher, University of Copenhagen:
Real-time Continuous Glucose Monitoring
Macrosomia
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases