Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes (GLIMPSE)
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to test their blood glucose at least four times daily. The investigators propose to prospectively evaluate blood glucose testing done every day compared to every other day. The primary goal is to establish the most cost-effective modality while still being able to detect patients who require therapy in a timely fashion. The investigators plan to evaluate this new management scheme utilizing a non-inferiority trial design.
The investigators primary research question is the following: When managing patients with GDM, is every other day blood glucose testing non-inferior compared to every day blood glucose testing, as measured by the difference of less than 5% in birth weight?
調査の概要
詳細な説明
This study is a prospective randomized, non-inferiority clinical trial of pregnant women diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and 32 weeks 0 days of gestation will be recruited. Diagnosis of GDM will be based on Carpenter and Coustan criteria for an abnormal 3-hr 100 gram oral glucose tolerance test, as currently supported by the American College of Obstetricians and Gynecologists (ACOG). Patients whose 1-hr, 50 gram oral glucose challenge test exceeds 200 mg/dl will not require a 3-hr oral glucose tolerance test (OGTT). If the patient meets the inclusion and exclusion criteria listed below, she will be offered participation in the trial and randomized to every day blood glucose testing or every other day blood glucose testing for the remainder of her pregnancy.
After the diagnosis of GDM, and before recruitment to the study, all patients will be provided counseling and education and will attempt adequate blood glucose control with medical nutritional therapy alone for one week. During this period, all patients will test their blood glucose values daily. Only after this week is completed will a subject be approached for participation.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Danville、Pennsylvania、アメリカ、17822
- Geisinger Health System
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Rhode Island
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Providence、Rhode Island、アメリカ、02905
- Women & Infants Hospital
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Texas
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Houston、Texas、アメリカ、77030
- The University of Texas Health Science Center, Houston
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Gestational age between 20 weeks 0 days and 32 weeks 0 days of gestation.
- Singleton pregnancies
- Maternal age over 18 years
- Patients able to read and write in English or Spanish,
- Diagnosis of gestational diabetes mellitus using criteria supported by the American College of Obstetrics and Gynecology (ACOG).
- Patients identified as not requiring medical therapy (insulin or glyburide) after the first week of initial blood glucose monitoring.
Exclusion Criteria:
- Diagnosis of GDM made by any method or criteria other than the one outlined above
- Women with pre-existing diabetes mellitus
- Patients under the age of 18 years
- Patients known to be carrying a fetus with a fetal anomaly that requires either prenatal or postnatal surgery, requires early delivery or is at risk for intrauterine growth restriction (IUGR)
- Patients carrying multiple gestations
- Patients with past history of gastric bypass
- Patients with poorly controlled asthma, defined as the need for oral/inhaled corticosteroids to control symptoms
- Patients with chronic hypertension requiring medical therapy
- Patients currently on methadone/suboxone therapy
- Patients currently on any steroid therapy, regardless of the dose or route of administration
- Patients demonstrating poor compliance during the first week of initial blood glucose monitoring, defined as <20% of expected values actually recorded during the one-week period of initial monitoring
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Every day blood glucose testing
Patients will test their blood glucose values 4 times every day
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実験的：Every other day blood glucose testing
Patients will test their blood glucose 4 times every other day
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Patients will be assigned either to blood glucose monitoring done every day (during a fasting state and 2 hours after breakfast, lunch and dinner) continued throughout gestation or to blood glucose monitoring done every other day with the same timeframes outlined above.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neonatal weight
時間枠：At birth
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In patients with GDM, every other day blood glucose testing is non-inferior to every day blood glucose testing, as measured by the difference of less than 5% in birth weight
|
At birth
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Macrosomia
時間枠：At birth
|
To determine if every other day testing is associated with a greater rate of macrosomia, defined as birth weight > 4,000 grams, than every day blood glucose testing
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At birth
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協力者と研究者
捜査官
- 主任研究者：Hector Mendez-Figueroa, M.D.、The University of Texas Health Science Center, Houston
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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