My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycemic Control at 3 Months
研究概览
简要总结
The purpose of this research study is to evaluate an electronic application (app) designed to help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is called My Dose Coach. This research study is being done in 2 phases. Specifically in Phase 1, the study is assessing the role of the My Dose Coach app in helping participants make insulin adjustments to get their blood glucoses to the target level that is planned for with the diabetes team, called the dosing or titration phase, when first starting insulin. In Phase 2, the study is assessing the role of the My Dose Coach app in helping participants keep blood glucoses in the target range, called the maintenance phase.
详细描述
Despite the increasing body of knowledge of diabetes treatment strategies, a majority of patients with T2DM are still in a persistent state of poor glycemic control and unable to meet target goals. Inertia surrounding insulin initiation and titration is a specific problem. Various approaches have been proposed to help overcome clinical inertia, including support of patient self-management, and education for both physicians and people with diabetes. Presently, paper-based guides are available in which clinicians/educators rely on to help their patients in determining and recording appropriate insulin doses. Unfortunately, this process often sets the stage for reluctance and fear of insulin initiation and delays titration with implications for long-term poor self-management and adherence. Therefore, Sanofi developed the My Dose Coach electronic app to assist with optimizing titration of basal insulins and supporting proper insulin maintenance. The primary objective of this two phase study is to demonstrate that patients who are trained on the My Dose Coach app to titrate insulin will have greater improvements in hemoglobin A1c and will be more likely to achieve glycemic control at three months as compared to usual care practice, and, for the intervention group only, those who do attain glycemic goals will be able to maintain glycemic control for an additional three months. The secondary objective of this study is to examine the feasibility of integrating digital solutions into clinical workflow and user acceptability of My Dose Coach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intervention Group
- •Patient receiving care at a UPMC Diabetes Outpatient and/or Inpatient settings
- •Adult male and female patients 18 to 75 years old
- •HbA1c > 7.5%
- •Recommended to start self titration of basal insulin
- •Access to and able to use an iOS (Apple phone operating system) or Android enabled device and have reliable internet access
- •Willing and able to use the MDC app
- •Able to comprehend basic diabetes survival skills, signs and symptoms of hypoglycemia and treatment of BG
- •Usual Care Group
- •Adult male and female patients 18 to 75 years old
- •HbA1c > 7.5%
- •Started on basal insulin in a UPMC Diabetes Outpatient facility within the past three years of study start
- •Has blood glucose data available in electronic medical records (EMR) (At least two HbA1c measurements corresponding to baseline and a subsequent time point after insulin titration)
排除标准
- •Pregnant or breastfeeding
- •Patients unwilling to use MDC app
研究组 & 干预措施
My Dose Coach (Insulin Dosing Support App)
Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months.
Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6.
Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.
干预措施: Smartphone application and web portal (Device)
My Dose Coach (Insulin Dosing Support App)
Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months.
Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6.
Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.
干预措施: Standard Insulin Therapy Education (Behavioral)
Usual Care Group
A retrospective comparative group will be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group will be identified using data available in the electronic medical record system. Propensity score matching will be used to pair intervention and usual care participants during phase 1 of the study (baseline to 3 months).
干预措施: Standard Insulin Therapy Education (Behavioral)
结局指标
主要结局
Change From Baseline in Glycemic Control at 3 Months
时间窗: Baseline to 3 months
Average change in hemoglobin A1c from baseline to 3 months
次要结局
- Proportion of Patients Who Achieve Glycemic Targets(3 months)
- Proportion of Patients Who Maintain Glycemic Targets(6 months)
- Number of Hypoglycemic Events(As reported across study period, up to 6 months)
- Change From Baseline in Diabetes Distress at 6 Months(Baseline to 6 months)
- Change From 3 Months in Diabetes Distress at 6 Months(Month 3 to month 6)
- Participant Satisfaction With Insulin Treatment(6 months)
- Change From Baseline in Fasting Blood Glucose at 6 Months(Baseline to 6 months)
- Change From 3 Months in Fasting Blood Glucose at 6 Months(Months 3 to 6)
- Change From Baseline in Diabetes Distress at 3 Months(Baseline to 3 months)
- Participant Acceptability of Insulin Dosing Support System for Insulin Titration(3 months)
- Change From Baseline in Fasting Blood Glucose at 3 Months(Baseline to 3 months)
- Change From Baseline in Hemoglobin A1c at 6 Months(Baseline to 6 months)
- Change From 3 Months in Hemoglobin A1c at 6 Months(Months 3 to 6)
- Number of Participants Who Experienced Severe Hypoglycemic Events.(As reported across study period, up to 6 months)
研究者
Linda Siminerio
Professor of Medicine
University of Pittsburgh