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临床试验/NCT06005987
NCT06005987招募中不适用

Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes

Carolyn Zahler-Miller2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Compliance

研究概览

简要总结

To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.

详细描述

Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is often the first time they've had to keep such strict logs. Patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. Subjects will be recruited from the Augusta University downtown location obstetric clinics.

Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (GTT) > 200mg/dL or 3h GTT with 2 or more abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application to track blood sugar readings, and type 1 diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Cannot mask participant who needs to use the mobile application, or their care provider, or the investigator who will need to teach the patient how to use the application.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and older
  • Verified intrauterine pregnancy
  • At least 12 weeks gestation
  • Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus.

排除标准

  • Patients with less than 4 weeks anticipated to be remaining in pregnancy
  • Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking
  • Type 1 diabetes mellitus
  • Non-English speaking patients

结局指标

主要结局

Compliance

时间窗: 4 weeks

percentage of actual blood glucose values logged compared to expected.

次要结局

  • Percentage of in-range blood glucose levels(4 weeks)

研究者

发起方
Carolyn Zahler-Miller
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carolyn Zahler-Miller

Associate Professor

Augusta University

研究点 (2)

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