Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Regulation of blood glucose excursions, measured by hemoglobin A1c at the end of the 3 month study period and again after an additional 3 month follow-up period
研究概览
简要总结
This study will help determine whether the use of a wireless glucose meter and and an internet-based automated diabetes management system to organize blood glucose values will help improve glucose control during the start of continuous subcutaneous insulin infusion therapy by an insulin pump device in patients with type 1 diabetes. Outcome measures to be determined include an assessment of glucose excursions, overall glucose control, health care team staff and patient time required and a satisfaction survey.
详细描述
The study is focused on the following objectives:
- Determine whether the use of the GlucoDYNAMIX™ diabetes intervention system and the GlucoMON™ telemetry device will facilitate faster regulation of blood glucose excursions into a well-controlled range, compared to conventional monitoring and reporting.
- hemoglobin A1c at the end of the 3 month study period and again after an additional 3 month follow-up period to account for a possible for an extended difference between the groups;
- magnitude of glucose excursions and fluctuations as indicated by the standard deviation between glucose tests to indicate relative glucose control and the mean daily glucose value over the 3 month period following the initiation of pump therapy; and,
- frequency of severe hypoglycemia and extended hyperglycemia.
- Determine whether use of the GlucoDYNAMIX intervention system, during initiation of adult insulin pump starts, results in a measured saving of staff time in support of data collection, analysis and patient feedback including delivery and follow-up to monitor effects on glucose control from patient implementation of prescribed changes. This objective will be measured by:
- tracking the number of interventions each day;
- estimating the amount of time spent collecting, analyzing and communicating with each study patient; and,
- daily logs will be tallied and verified weekly.
- To determine through use of questionnaires administered to the patients and to the professional staff whether use of the technology results in perceived improvement in the quality of care and improved satisfaction for all involved. This objective is primarily concerned with people's willingness to commit to using a similar technology as standard practice for future initiation of insulin pump starts for adult patient with diabetes mellitus.
Study Design and Description The study is designed to run for a period of 3 months of intensive management for each enrolled patient as they begin insulin pump therapy plus detailed glucose records beginning 4 weeks prior to the initiation of insulin pump therapy. Understanding relative glucose control following intensive management requires that we consider the results of the patient's HbA1c 3 months after conclusion of intensive management thus extending the time frame to 6 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must reside in the Philadelphia area and participate in regular in person visits to the Jefferson Diabetes Research Center. Patients must be at the stage of their treatment where they are going to initiate insulin infusion pump therapy. Patients must be at least 18 years of age before starting the protocol and must have never used an insulin pump before. Ideally, at least a few of the study participants will use English as a second language. Since the technology is capable of delivering messages to the wireless email device in several languages including Spanish and French, there is no English only requirement. Likewise, patients not capable of operating the wireless email device will be included since the GlucoMON device is specially designed to enable patient use without technology aptitude typical for personal computers and interactive wireless devices.
排除标准
- •Patients living outside the Philadelphia area and those that are not immediately going to initiate insulin pump therapy wil be excluded. Patients unwilling to perform at least 4 blood glucose self-tests will be ineligible for participation in this study. Conventional guidelines for minimum self-care will apply including criteria for discontinuance of insulin pump therapy.
结局指标
主要结局
Regulation of blood glucose excursions, measured by hemoglobin A1c at the end of the 3 month study period and again after an additional 3 month follow-up period
Magnitude of glucose excursions and fluctuations as indicated by the standard deviation between glucose tests to indicate relative glucose control and the mean daily glucose value over the 3 month period following the initiation of pump therapy
次要结局
- Frequency of severe hypoglycemia and extended hyperglycemia.
- Saving of staff time in support of data collection, analysis and patient feedback including delivery and follow-up to monitor effects on glucose control from patient implementation of prescribed changes.
- Whether use of the technology results in perceived improvement in the quality of care and improved satisfaction for all involved