Evaluation of a Mobile Application Designed to Support Type 1 Diabetic Patients in Adjusting Their Insulin Doses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Glycated Hemoglobin (HbA1c)
研究概览
简要总结
Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients.
The goal of this clinical trial is to determine whether a mobile health application can improve insulin management and blood sugar control in Iraqi patients with Type 1 Diabetes aged over 15 years who are on intensive insulin therapy. The main question it aims to answer is:
Does the use of the mobile application lead to a greater reduction in HbA1c levels compared to standard care alone?
Researchers will compare the group using the mobile application to the group receiving standard care alone to see if the application is more effective at improving glycemic control.
Participants will be assigned to one of two groups for the 3-month study.
Either use the mobile application to guide their daily insulin dose adjustments alongside standard care, or receive standard care alone.
Undergo blood tests (including HbA1c) and complete questionnaires about hypoglycemic events, insulin adherence, and quality of life.
详细描述
Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients.
1.0 Study Design and Rationale This is a prospective, two-arm, quasi-randomized controlled clinical trial conducted at a specialized diabetes center in Iraq. The study is designed to evaluate the efficacy of a novel mobile health (mHealth) application, specifically developed for the Iraqi patient context, as an adjunctive tool for managing Type 1 Diabetes Mellitus (T1DM). The rationale is to determine if algorithm-guided, patient-self-managed insulin adjustments facilitated by the app can lead to superior glycemic control compared to traditional physician-led dose adjustments alone.
2.0 Methodology
2.1 Patient allocation and blinding: Participants will be allocated in a 1:1 ratio to either the intervention or control group. Allocation will be performed using a predefined alternation sequence based on the order of enrollment. Due to the nature of the intervention, participants cannot be blinded to their group assignment. However, outcome assessors and data analysts will be blinded to group allocation wherever possible.
2.2 Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (≥15 years), with uncontrolled (HbA1c ≥ 7) type 1 diabetes who were treated with multiple daily insulin injections (MDI) for at least 3 months before the study date.
- •Patients who are willing to test their blood glucose level at least 3 times daily during the study period.
- •Participants who will give their informed consent to participate in the study. -
排除标准
- •Pregnant woman or planning to be pregnant
- •Patients at high risk of developing hypoglycemia (e.g., those with IHD, osteoporosis, hypoglycemia unawareness).
- •Patients with psychiatric disorders.
- •Patients who will be subjected to a major change in insulin dose (more than 20%) at the start or during the study period.
- •Patients who don't use the application during the study period. The usage Metrics of the application will be watched on Google Analytics
研究组 & 干预措施
mHealth Application + Standard Care
Participants trained to use the mHealth mobile application as an adjuvant in addition to their usual care.
干预措施: mHealth Mobile Application (Device)
mHealth Application + Standard Care
Participants trained to use the mHealth mobile application as an adjuvant in addition to their usual care.
干预措施: Standard Care (in control arm) (Other)
Standard Care Only
Participants will receive physician-led standard care for type 1 diabetes without using the mobile application.
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c)
时间窗: Baseline (Day 0) and Post-intervention (Month 3)
The difference in HbA1c levels, measured as a percentage (%), from baseline to the end of the study after 12 weeks. HbA1c will be measured from blood samples analyzed in a hospital laboratory. A negative change indicates improvement.
次要结局
未报告次要终点
研究者
Noor Kadhim
Principal Investigator, PhD Candidate at College of pharmacy/University of Baghdad. Has MSC in Clinical Pharmacy and Lecturer at College of Pharmacy-University of Basrah.
University of Baghdad