A Pilot Study of Nocturnal Hypoglycemia Prevention in Type 1 Diabetes Using the Vigilant Diabetes Management Companion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Reduction in the aggregate rate of nocturnal biochemical severe hypoglycemia in the Vigilant period versus the Baseline period as measured by meter or logged blood glucose values (mg/dL).
研究概览
简要总结
A single center pilot study assessing the Vigilant Diabetes Management Companion for the prevention of recurrent nocturnal hypoglycemia in type I diabetes patients.
详细描述
This is a pilot study to determine whether a large-scale randomized trial is feasible. The pilot study will test if the Vigilant Diabetes Management System is effective in adults with T-I Diabetes in preventing nocturnal hypoglycemia, improving moderate hypoglycemia, improving diabetes quality of life and in reducing fear of hypoglycemia.
2ndary aim: Health care professional adoption of the technology - medication titrated or changed, reports that the system facilitated treatment decisions, provided meaningful feedback and or reduced time.
This is a single center 12-week Pilot trial with one arm. Subjects will serve as their own controls. The study will include usual care patients on MDI (multiple daily injections) or CSII (continuous subcutaneous insulin infusion) with the additional use of the Vigilant Diabetes Management System. There will be a 4-week baseline period prior to the 12-week intervention. Subject participation for the 4-week baseline period will last for 2 to 4 hours during two visits. Subjects participating in the intervention phase of 12 weeks will require one additional visit for 2 to 3 hours at 3 months, which is routine for this population.
Participants will be provided with a wireless blood glucose meter for the duration of the study and will download the Vigilant mobile application to their mobile phone.
The Vigilant system stores blood glucose test results, pattern events, and user settings. In addition to receiving blood glucose measurements entered from the user, storing and displaying them, Vigilant provides the following features and tools for the user:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •• Male or female participants aged between 18 and 75 years
- •Clinical diagnosis of type 1 diabetes mellitus and using multiple daily injections or CSII for at least six months
- •Patient has had documented nocturnal hypoglycemia in the last 2 months with an associated blood sugar reading less than 56mg/dL. Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example).
- •Patient has had at least 1 severe low at night in the last 6 months (helped by another). Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example).
- •Willing to monitor and record signs and symptoms of hypoglycemia
- •Willing to test blood glucose levels at least three times a day
- •Ability to use Android or IOS mobile phone
- •No CGM Users
排除标准
- •• Pregnancy
- •Unable to use the technology
- •Any condition that in the investigators judgment is likely to cause the participant to be unable e to understand or provide informed consent
- •Unwilling to use SMBG at least three times a day
- •Unwilling to monitor and record signs and symptoms of hypoglycemia
- •Individuals who are unwilling to share their glucose meter data
结局指标
主要结局
Reduction in the aggregate rate of nocturnal biochemical severe hypoglycemia in the Vigilant period versus the Baseline period as measured by meter or logged blood glucose values (mg/dL).
时间窗: 3 months
Nocturnal biochemical severe hypoglycemia is defined by 1) a reading below 56 mg/dL at night OR 2) a severe low (requires assistance from another) at night. Night is defined as the 8 hour interval when the patient usually sleeps (ie. 11:00pm to 7:00 am, for example). Baseline is defined as collected glycemic data prior to Vigilant initiation as well as the run-in period.
Reduction in the aggregate rate of nocturnal hypoglycemia in the Vigilant period versus the Baseline period as measured by meter or logged blood glucose values (mg/dL).
时间窗: 3 months
Nocturnal hypoglycemia is defined by 1) a reading below 70 mg/dL at night OR 2) a severe low (requires assistance from another) at night.Night is defined as the 8 hour interval when the patient usually sleeps (I.e. 11:00 pm to 7:00 am, for example). Night is defined as the 8 hour interval when the patient usually sleeps (ie. 11:00pm to 7:00 am, for example. Baseline is defined as collected glycemic data prior to Vigilant initiation as well as the run-in period.
次要结局
- An aggregate (total study population) reduction in the rate of mild hypoglycemia (biochemical and logged) as measured by home blood glucose values <70 mg/dL at 3 months, compared to the monthly rate of hypoglycemia in the Baseline period.(3 months)
- An aggregate reduction in average HbA1will be measured at baseline using DCA 2000 or equivalent NGSP- certified point-of-care method or local laboratory at 3 months, compared to HbA1c levels obtained at study initiation.(3 months)
- An aggregate reduction in the rate of biochemical severe hypoglycemia as measured by home blood glucose values <40 mg/dL, during months 1-3, compared to the monthly rate of biochemical severe hypoglycemia in the Baseline period.(3 months)
- An aggregate (total study population) reduction in the LBGI and HBGI, as measured by percent of readings in and out of range calculated based on downloaded blood glucose meter download data.(3 months)
- Reduction in reported fear of hypoglycemia as compared to baseline Fear of Hypoglycemia Fear Survey. The Hypoglycemia Fear Survey II (HSF II) will be used.(3 months)
- Improvement in self-reported lost work productivity as a result of hypoglycemia. Individuals will complete a questionnaire about lost work days as a result of hypoglycemia at baseline and at 3 months.(3 months)
- Improvement in self-reported psychosocial self-efficacy as compared to baseline measured using the Diabetes Empowerment Scale Short Form (DES-SF).(3 months)
- An aggregate reduction in the survey self-reported rate of use of; 1) Glucagon 2) Emergency medical services for hypoglycemia, and 3) Hospital, urgent care or clinic visits for hypoglycemia or associated with hypoglycemia care visits.(3 months)
- An aggregate reduction in the mean glycemic variability, as measured by monthly ADRR (Average Daily Risk Range), calculated based on downloaded meter download data(3 months)