Continuous glucose monitor for Diabetes, Gestational

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Washington, Seattle, WA
Diabetes, Gestational+2 More
Continuous glucose monitor - Device
Eligibility
Any Age
Female
Eligible conditions
Diabetes, Gestational

Study Summary

This study is evaluating whether continuous glucose monitoring may help improve glucose control in individuals with gestational diabetes.

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Eligible Conditions

  • Diabetes, Gestational
  • Diabetes Mellitus
  • Gestational Diabetes Mellitus (GDM)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Continuous glucose monitor will improve 2 primary outcomes in patients with Diabetes, Gestational. Measurement will happen over the course of 4 years.

4 years
Health of baby using delivery and post delivery well baby assessments
Health of mother using CGM to monitor blood glucose during pregnancy

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Secondary Cohort RT-CGM Group
Severe Hypoglycemia
10%
Kidney laceration
0%
Seizure not caused by hypoglycemia
0%
Diabetic ketoacidosis
0%
Cellulitis related to sensor use
0%
Anxiety and depression
0%
Dizziness during blood draw
0%
This histogram enumerates side effects from a completed 2009 Phase 3 trial (NCT00406133) in the Secondary Cohort RT-CGM Group ARM group. Side effects include: Severe Hypoglycemia with 10%, Kidney laceration with 0%, Seizure not caused by hypoglycemia with 0%, Diabetic ketoacidosis with 0%, Cellulitis related to sensor use with 0%.

Trial Design

2 Treatment Groups

Control
Blinded Continuous Glucose Monitoring Devise

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Continuous Glucose Monitor is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Blinded Continuous Glucose Monitoring Devise
Device
If you are in the control group, you will wear a continuous glucose monitor with the read out screen covered so you can not see your continuous glucose level. You will be taught how to test your blood sugar by pricking your finger and using a standard blood glucose meter as per the standard of care used by your provider in the obstetrics clinic.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous glucose monitor
2006
Completed Phase 3
~600

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 years for reporting.

Who is running the study

Principal Investigator
N. E.
Prof. Nicole Ehrhardt, Assistant Professor, School of Medicine
University of Washington

Closest Location

University of Washington - Seattle, WA

Eligibility Criteria

This trial is for female patients of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If you have been diagnosed with gestational diabetes, you will need to follow a specific diet and exercise plan to keep your blood sugar levels under control. show original
Can read and write in English and has completed the sixth grade. show original
and restrictions I can read, understand, and sign the Informed Consent Form (ICF), and if applicable, an Authorization to Use and Disclose Protected Health Information form show original
A pregnancy is said to be viable if it is past 28 weeks gestation show original
means a pregnancy in which there is only one baby show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get diabetes, gestational a year in the United States?

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Diabetes affected 8.3% of US women in 2006 and 5% in 2008/2009. Of women presenting for care, diabetes prevalence varied substantially by region, ethnicity, age and obesity. Diabetes prevalence in US births was 7.7% in 2006/2007. In the absence of a national diabetes surveillance program and reporting requirements, current estimates of diabetes prevalence in US women of childbearing age and US pregnant women are not reliable to understand the prevalence of diabetes and its complications in the US population.

Unverified Answer

What is diabetes, gestational?

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Diabetes during pregnancy increases the risk of most of the serious adverse outcomes of pregnancy. Gestational diabetes is characterized by insulin imbalance, gestational hypertension, and fetal macrosomia/microsomia (fetal growth patterns).\n

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Can diabetes, gestational be cured?

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With proper management, gestational diabetes can be cured. However, it should be recognized that pregnancy can be a stressful experience for both women and their unborn babies. With appropriate advice and supportive care, gestational diabetes and pregnancy can lead to successful pregnancies with healthy babies.

Unverified Answer

What causes diabetes, gestational?

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The pathogenesis of diabetes, gestational is multifactorial, and the major pathophysiological mechanisms are insulin resistance and impaired insulin secretion. The key to the genesis of gestational diabetes is an increased secretion of proinflammatory cytokines, and a decreased insulin secretion.

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What are common treatments for diabetes, gestational?

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Diabetes is often treated with oral antidiabetic agents and insulin. Gestational diabetes is treated with dietary measures and medication to stop its symptoms. Both are common conditions that require close management.

Unverified Answer

What are the signs of diabetes, gestational?

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Diabetes in pregnancy is characterized by nausea and vomiting, thirst and frequent urination. Other signs of diabetes include an elevated blood glucose level and gestational diabetes. Pregnancy can occur in women with diabetes and without a history of the illness.

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What is the latest research for diabetes, gestational?

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There is increased knowledge, and a tendency to focus on prevention and treatments of diabetes. As knowledge and understanding of diabetes evolves, there is a need to provide information and support for people with diabetes and their families. It is important that healthcare providers have information and support for people with diabetes and their families.

Unverified Answer

Is continuous glucose monitor typically used in combination with any other treatments?

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We suggest the use of CGM in patients not only using multiple treatments but also in those with a long duration of diabetes (e.g. more than 5 years). In the patients who have been treated with insulin for more than 5 years, the effects of long-term use of insulin on blood glucose and insulin sensitivity may be a contraindication for CGM use. However, the potential benefits of CGM should be weighed against the risks of using it.

Unverified Answer

Has continuous glucose monitor proven to be more effective than a placebo?

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On the basis of the present data, it would appear that CGMS has proven to minimize glucose variability, with less hypoglycemic events in comparison to control group. Therefore, this promising device seems to be potentially useful in type 2 diabetes management, especially with regard to the patients not achieving glycemic control through conventional pharmacological therapies.

Unverified Answer

Who should consider clinical trials for diabetes, gestational?

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Diabetes, gestational diabetes, and gestational hypertension have low absolute and relative contribution to clinical trials but should all be screened. The majority of women consider clinical trials for gestational diabetes.

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Does continuous glucose monitor improve quality of life for those with diabetes, gestational?

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CGMs resulted in meaningful reductions in glycemia in all respondents, despite a few shortcomings. There was minimal impact on the overall QOL or bother, except for those who reported a sense of well-being.

Unverified Answer

What is the primary cause of diabetes, gestational?

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In a recent study, findings of this study suggest that women with diabetes or gestational diabetes have increased insulin resistance when compared to women without diabetes. Although secondary insulin resistance did not increase significantly from baseline to 24-28 weeks gestation, it increased significantly from 28 to 32 weeks and was significantly higher than baseline at 36 weeks gestation when compared to women with gestational diabetes with secondary insulin resistance. We speculate that the cause of this increased secondary insulin resistance may be related to the pregnancy process.

Unverified Answer
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