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

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 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

Genetic and Rare Diseases Information Center resources: Fetal Macrosomia

U.S. FDA Resources

Further study details as provided by Anna Lilja Secher, University of Copenhagen:

Primary Outcome Measures:

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

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 ]
Quality of life, locus of control and anxiety and depression scores in pregnant diabetic patients. [ Time Frame: 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 ]
The occurrence of low grade inflammation and endothelial dysfunction in pregnant women with diabetes. [ Time Frame: During pregnancy ]


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)
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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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):

Cordua S, Secher AL, Ringholm L, Damm P, Mathiesen ER. Real-time continuous glucose monitoring during labour and delivery in women with Type 1 diabetes - observations from a randomized controlled trial. Diabet Med. 2013 Nov;30(11):1374-81. doi: 10.1111/dme.12246. Epub 2013 Jul 26.

Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24.


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

Keywords provided by Anna Lilja Secher, 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 July 19, 2017