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

May 8, 2012 updated by: Anna Lilja Secher, University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of LGA in children of diabetic women.
Time Frame: Obtained shortly after birth
Obtained shortly after birth

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Study Chair: Elisabeth R Mathiesen, M.D., Center for Pregnant Women with Diabetes, Copenhagen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Estimate)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENSOR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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