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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Real-time Continuous Glucose Monitoring on Severe Complications to Pregnancy in Women With Diabetes: a Randomised Controlled Study

Conditions
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Diabetes, Pregnancy

Intervention / Treatment
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* Device: Real-time CGM
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time Continuous Glucose Monitoring<br>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<br>* See previous description.<br>|
| Active Comparator: Control group<br>Standard monitoring and treatment of diabetic patients during pregnancy. | Other: Standard care<br>* See text.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-time Continuous Glucose Monitoring, Macrosomia