Development and Feasibility Testing of the "MyGlucoCare" Smartphone-Based Self-Management for Personalised Support of Women With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Enagagement
研究概览
简要总结
The goal of this pilot study is to test the feasibility and preliminary impact of "MyGlucoCare," a smartphone-based program designed to support women with gestational diabetes (GDM). The main questions it aims to answer are:
Is the "MyGlucoCare" program practical and acceptable for participants?
Does it show preliminary signs of improving self-management, blood sugar control, and well-being in women with gestational diabetes (GDM)?
Researchers will conduct a single-arm study to gather initial data on the program's use and effects, which will be used to plan a larger future clinical trial.
Participants will:
Use the "MyGlucoCare" app for 8-12 weeks during their pregnancy.
Receive personalized education, support from a clinician, and access to a moderated peer group through the app.
Complete questionnaires and log health data via the app at the start, near the end of pregnancy, and after giving birth.
Some participants will also take part in an interview to share their feedback on the program.
详细描述
- Project Objectives
The objective of this pilot study is to evaluate the feasibility, acceptability, and preliminary impact of the "MyGlucoCare" smartphone program, which provides holistic self-management support for women with gestational diabetes mellitus (GDM).
The primary aim is to determine the feasibility of the research procedures and the acceptability of the "MyGlucoCare" program itself. This will involve assessing participant recruitment, retention, and data completion rates to evaluate feasibility. The program's acceptability and usability will be evaluated from the participants' perspective by measuring their engagement and subjective experiences.
The secondary aim is to gather preliminary evidence of the program's potential impact. This includes obtaining initial estimates of its effect on self-efficacy for diabetes management and self-reported self-management behaviours. The study will also explore preliminary changes in key clinical and behavioural markers, specifically glycemic control (measured by pre- and post-meal blood glucose levels), physical activity levels, and perceived stress levels. Finally, a descriptive exploration of relevant maternal and neonatal pregnancy outcomes will be conducted to inform future research. 2. Project Plan and Methodology
Study Design: A single-arm pilot study with a pre-test/post-test design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women diagnosed with Gestational Diabetes Mellitus (GDM) via a 75g Oral Glucose Tolerance Test (OGTT), conducted between 24 and 28 weeks of gestation (Hong Kong College of Obstetricians and Gynaecologists, 2016).
- •Aged 18 years or older.
- •Own a smartphone with reliable internet access.
- •Able to read and understand Chinese.
排除标准
- •Pre-existing diagnosis of Type 1 or Type 2 diabetes mellitus.
- •Known major fetal anomaly.
- •Concurrent enrollment in any other structured GDM self-management intervention.
- •Severe mental health conditions.
研究组 & 干预措施
"MyGlucoCare" intervention
The "MyGlucoCare" intervention is a comprehensive, technology-facilitated program delivered over 8 to 12 weeks.
干预措施: MyGlucoCare (Device)
结局指标
主要结局
Enagagement
时间窗: 8-12 weeks
Measures participant interaction with the study protocol and app (%). • Measures: Mean/median frequency of (e.g., per week)
Recruitment & Retention Rates
时间窗: 8-12 weeks
Assesses the practicality of executing the trial. • Unit of Measure: Proportion/Percentage (%) for each
System Usability
时间窗: 8-12 weeks
Quantifies the perceived usability of the "MyGlucoCare" app using a validated instrument.• Measure: Mean score on the System Usability Scale (SUS). • Unit of Measure: Score on a scale (0-100).
次要结局
- Secondary outcome measures(All changes measured from baseline (T0) to post-intervention (T1, 8-12 weeks), except postpartum OGTT and delivery outcomes collected at T2 (postpartum period).)
研究者
Dr Bronya LUK Hi Kwan
Assistant Professor
Hong Kong Metropolitan University