Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for frequent and timely monitoring is now feasible. The investigators propose to leverage this new technology to provide children and families with appropriate interventions to help manage their diabetes.
详细描述
The investigators will collect insulin dosing via pump records, blood glucose meter, continuous glucose sensor, activity, heart rate, and sleep data on a weekly basis from 100 children with diabetes. The investigators hypothesize that with the collection and analysis of insulin, blood glucose, sensor, activity, heart rate and sleep data in children with diabetes the investigators can identify glucose patterns and predictors of acute events.
The 100 children will be randomized to either conventional therapy (data upload group) or intensive remote therapy (weekly review group). Conventional therapy will consist of routine quarterly visits to the clinic and as-needed communication with the diabetes staff, initiated by the family, between study visits. Intensive remote therapy will consist of routine quarterly visits to the clinic along with weekly remote review of insulin and blood glucose data by the research staff, and additional communication with the family, initiated by the diabetes staff as needed, between visits. The investigators hypothesize that with weekly, manual review of real-time insulin, glucose, and activity data in children with diabetes, and recommended regimen changes based on the data, the investigators will be able to lower HbA1c values in children in the weekly review group as compared to children in the data upload group.
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
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes, using an insulin pump (Medtronic, Omnipod, Animas)
- •Duration of diabetes >1 year
- •Age: 8-17 years of age, inclusive.
- •Hemoglobin A1c 8.0-10.0% at baseline visit, inclusive.
- •Seen in the McNeely Diabetes Clinic within the past 6 months.
- •The family/child is testing blood glucose at least 4 times a day.
- •The family has a smart phone and service.
排除标准
- •The child is not using insulin for management of diabetes.
- •The child uses multiple daily injections of insulin.
- •The child is unwilling to use the wearable device, or the family is unwilling or unable to upload glucose and insulin data on a routine basis
- •The family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device.
- •Diagnosis of a mental health disorder.
- •Parent/child does not speak English as the device software is only available in English.
研究组 & 干预措施
Data Upload
Subjects will wear a FitBit activity monitor and continue to use their insulin pump. FitBit, pump and sensor (if applicable) data will be uploaded at least weekly. Subjects will continue to receive usual diabetes care. Phone calls and emails to the diabetes clinic will be initiated by the family.
干预措施: FitBit (Device)
Weekly Review
Subjects will wear a FitBit activity monitor and continue to use their insulin pump. FitBit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (diabetes educator, nurse practitioner and/or physician) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations.
干预措施: Weekly Review (Other)
Weekly Review
Subjects will wear a FitBit activity monitor and continue to use their insulin pump. FitBit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (diabetes educator, nurse practitioner and/or physician) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations.
干预措施: FitBit (Device)
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: From baseline to 6 months
Change in HbA1c from baseline to 6 months
次要结局
- Diabetes Family Conflict Scale (DFCS)(6 months)
- Health care utilization(6 months)
- PedsQL Inventory (PedsQL)(6 months)
- Center for Epidemiology Scale- Depression (CES-D) survey(6 months)
- Problem Areas in Diabetes (PAID) survey(6 months)
- Change in Hemoglobin A1c(Change from 6 months to 9 months)