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Threshold for Initiation of Medical Treatment for Women With Gestational Diabetes (TIME)

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ClinicalTrials.gov Identifier: NCT03527537
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Anna Palatnik, MD, Medical College of Wisconsin

Brief Summary:
The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Drug: Insulin Drug: Glyburide Drug: Metformin Phase 4

Detailed Description:

Gestational diabetes mellitus (GDM) affects 5-8% of pregnant women, many of whom will require treatment beyond diet and exercise. Despite this high prevalence, there is no consensus regarding the glycemic threshold for conversion from diet to medical treatment for GDM. No randomized studies have been performed on how to define failure with diet and exercise and currently, the need to start insulin or oral hypoglycemic agents is at the provider's discretion. It is important to establish criterion of pharmacotherapy initiation for GDM in pregnancy as GDM under-treatment leads to increased rates of adverse obstetric outcomes associated with poor glycemic control including macrosomia, pre-eclampsia, cesarean delivery, shoulder dystocia, birth trauma, neonatal hypoglycemia and hyperbilirubinemia, childhood obesity and metabolic syndrome in the offspring. In contrast, overtreatment for women comes at increased cost due to overutilization of resources, increased expense, and adverse effects of the medications themselves.

The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM (N=284) will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.

Aim 1: To compare the rate of a composite outcome between two thresholds for medical treatment initiation for GDM. Women who receive the diagnosis of GDM and meet eligibility criteria will be randomized to start insulin or an oral hypoglycemic agent when the number of CBG values above target reaches 20% or 40%. The primary outcome will be a composite of neonatal macrosomia, shoulder dystocia, neonatal hypoglycemia, neonatal hyperbilirubinemia, preterm delivery, neonatal intensive care unit (NICU) admission, and stillbirth or neonatal death. The investigators hypothesize that women who receive treatment with stricter limits of abnormal blood glucose levels will have lower rates of these poor outcomes.

Aim 2: To compare the rates of cesarean delivery between two thresholds for medical treatment initiation for GDM. The investigators hypothesize that women who receive treatment with stricter limits of abnormal blood glucose levels will have lower rates of cesarean delivery.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a randomized, controlled trial of 284 women with a diagnosis of GDM. Women will be consented and randomized at the time of their diagnosis. All women with GDM will receive counseling regarding diet and exercise and instructions on self-monitoring blood glucose values. The investigators will apply cutoffs of 95 mg/dL for fasting and 120 mg/dL for 2-hour post-prandial levels. Once randomized, the first treatment arm will be assigned to a limit of 20% abnormal values before we start treatment and to titrate up dosages as needed, while using the 20% threshold of abnormal CBG values at each subsequent review of glucose log. To specify, if more than 20% of values for the week are elevated, treatment would be initiated. Once treatment is initiated, the dosage of medication will be adjusted with cutoff of 20% of abnormal values per week. The second treatment arm will utilize the same protocol, however, the limit to start medications or adjust dosages will be 40% abnormal values.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Threshold for Initiation of Medical Treatment for Women With Gestational Diabetes: A Single Site Randomized Trial
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 20% cutoff group
Treatment intervention will be initiated with glyburide, metformin, or insulin if 20% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.
Drug: Insulin
Insulin may be administered base on glucose log values. The dosing of the insulin will be decided by the provider using typical management of gestational diabetes.

Drug: Glyburide
Glyburide may be administered base on glucose log values. The dosing of the glyburide will be decided by the provider using typical management of gestational diabetes.
Other Name: Glynase

Drug: Metformin
Metformin may be administered base on glucose log values. The dosing of the metformin will be decided by the provider using typical management of gestational diabetes.
Other Name: Glucophage

Active Comparator: 40% cutoff group
Treatment intervention will be initiated with glyburide, metformin, or insulin if 40% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.
Drug: Insulin
Insulin may be administered base on glucose log values. The dosing of the insulin will be decided by the provider using typical management of gestational diabetes.

Drug: Glyburide
Glyburide may be administered base on glucose log values. The dosing of the glyburide will be decided by the provider using typical management of gestational diabetes.
Other Name: Glynase

Drug: Metformin
Metformin may be administered base on glucose log values. The dosing of the metformin will be decided by the provider using typical management of gestational diabetes.
Other Name: Glucophage




Primary Outcome Measures :
  1. Composite Neonatal Outcome [ Time Frame: The data will be collected up to 6 months of life ]
    Our primary outcome will be a composite of neonatal macrosomia, shoulder dystocia, neonatal hypoglycemia, neonatal hyperbilirubinemia, preterm delivery, neonatal intensive care unit (NICU) admission, and stillbirth or neonatal death.


Secondary Outcome Measures :
  1. Cesarean Delivery Rate [ Time Frame: The data will be collected up to 6 weeks postpartum ]
    Our secondary outcome will be to compare the rates of cesarean delivery between two thresholds for medical treatment initiation for GDM.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women will be randomized as this is a pregnancy-focused study
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Viable singleton pregnancy
  • Age >= 18 years old
  • Diagnosed with gestational diabetes mellitus

Exclusion Criteria:

  • Pre-gestational diabetes
  • Significantly abnormal blood glucose testing, suggestive of the presence of pre-gestational diabetes
  • Women who check blood sugars on average less than 2 times per day after appropriate counseling

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): NCT03527537


Contacts
Contact: Rachel K Harrison, MD 414-805-6023 rharrison@mcw.edu
Contact: Anna Palatnik, MD 414-805-6627 apalatnik@mcw.edu

Locations
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Anna Palatnik, MD Medical College of Wisconsin
Principal Investigator: Meredith Cruz, MD Medical College of Wisconsin

Publications:

Responsible Party: Anna Palatnik, MD, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03527537     History of Changes
Other Study ID Numbers: PRO00030802
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Insulin
Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs