Feasibility of Using a Smart Phone Application for Self-titration of Insulin on Glycemic Control in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in glycemic control (HbA1c) between the intervention and the control group
研究概览
简要总结
The primary aim of this study is to investigate the feasibility of using a patient-centered smart phone application for insulin self-titration on glycemic control. Over a 18-month period, suboptimally controlled type 2 diabetes mellitus (T2DM) on oral antidiabetic agents, thus requiring insulin treatment patients, will be recruited from the Singapore General Hospital (SGH). Patients randomized to the intervention group will be instructed to self-adjust their insulin dose using a smart phone application designed to guide self-titration; patients randomized to the control group will receive the usual clinical care. The primary outcome measure is change in glycated hemoglobin level (HbA1c), 6 months post-enrollment. The investigators hypothesize that using a smart phone application for insulin self-titration is effective in improving glycemic control in T2DM patients compared with usual care.
详细描述
Background:
Many patients with type 2 diabetes mellitus (T2DM) require insulin therapy after suboptimal glycemic control with oral antidiabetic agents. Initiating insulin therapy and adjusting dosage is vital in improving clinical outcomes among patients with diabetes. However, timely and appropriate dosage titration is challenging for many patients. Doctors also contend with many patients lacking the confidence to self-titrate insulin. Hence, reinforcing patients' self-empowerment is important in diabetes management. Developing tools that facilitate dosage adjustment of insulin may have substantial benefits to glycemic control.
Objectives:
The overall aim of this study is to investigate the feasibility of using a patient-centered smart phone application for insulin self-titration to improve glycemic control relative to usual care in patients with T2DM. The specific aim of the study is to determine the technical and clinical feasibility of a patient-centered smart phone application for insulin self-titration on glycemic control (HbA1c) of suboptimally controlled patients with T2DM who are starting insulin treatment.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insulin naïve patient with T2DM
- •Between 30 and 70 years of age
- •HbA1c ≥7.5%
- •Ability and willingness to inject once-a-day long-acting insulin
- •Ability and willingness to perform self-monitoring of blood glucose (SMBG)
- •Access to a smart phone
排除标准
- •Exclusion Criteria:
- •Hypoglycemia unawareness
- •Severe renal impairment (i.e., eGFR <30 ml/min)
- •Corticosteroid use
- •Serious disease with life expectancy <1 year
- •Pregnancy
- •Patients with labile medical conditions that would predispose them to poor insulin control (e.g., frequent or recurrent infections)
- •Patients with psychological and social issues that would prevent continuous injection of insulin and monitoring of blood glucose (e.g., major depressive disorder, homelessness)
研究组 & 干预措施
Control
Individuals in the control group will not use the smart phone application
Intervention
Individuals in the intervention group will use the smart phone application in insulin titration
干预措施: Smart phone application (Device)
结局指标
主要结局
Change in glycemic control (HbA1c) between the intervention and the control group
时间窗: Baseline and Week 24
次要结局
- Frequency of hypoglycemic episodes(up to Week 24)
- Treatment satisfaction as measured by DTSCs and DTSQc(Baseline and Week 24)
研究者
Dr. David Matchar
Professor and Director of the Program in Health Services and Systems Research, Duke-NUS Graduate Medical School Singapore
National University of Singapore