Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
研究概览
详细说明
Screening & End of 3-Week Run-in Period (Visit 1, Week 0) : Screening will be conducted by invitation to potentially eligible subjects. The study will be explained and written informed consent will be obtained from parents or patients (when 18 years of age or older) prior to conducting any study-related procedures. After written informed consent and patient assent (when <18 years of age) have been obtained, potential participants will undergo a history and physical exam. Girls of childbearing potential will have a urine pregnancy test performed at the time of the enrollment visit and the need for contraception for the entire duration of the study will be discussed. At this and all other study visits, participants/parents will meet with a diabetes care provider (i.e., a physician, nurse practitioner, or physician assistant) who will carry out a comprehensive review of diabetes management and review blood glucose and ketone records. The treatment regimen will be adjusted as clinically indicated during the initial screening visit and baseline data (including CGM and insulin dose data) will be collected in all participants during the 3-week run-in period of the study; HbA1c levels will be measured at the end of the 3-week baseline period in all eligible participants.
Baseline data obtained at the screening or 3-week baseline visit will include:
- Demographic characteristics, including family income, highest parental education attained, and number of individuals in the home
- 3-week data regarding CGM, insulin dose and Fitbit data
- Anthropometric measures (height, weight, BMI, vital signs) and physical exam
- Current diabetes care practices (frequency of self-monitored blood glucose (SMBG), insulin dosing, review of blood glucose values)
- Medical History: duration of diabetes, comorbidities, past medical history, social history, family history, medications, and allergies
- Additional diabetes history including current/past use of CGM, insulin pump, and other modes of diabetes technology
- Frequency of Emergency Department visits due to decompensated diabetes (i.e., hyperglycemia, ketosis and DKA) over the past 6 months
- Baseline laboratory assessment including lipid panel and urine microalbumin
Psychosocial Questionnaires will be administered
- Hypoglycemia Fear Survey (parent and child)
- Pittsburgh Sleep Quality Index
- Diabetes Treatment Satisfaction Questionnaire (DTSQ, DTSQc), which includes eight items, six of which form a scale (scored 0-36) in which higher scores indicate greater treatment satisfaction
- Diabetes-specific emotional distress using Problem Areas in Diabetes scale
After collection of all baseline data, eligible participants will be randomized to either the control or intervention group and receive instructions for the study. Participants will also be provided with a FitBit and instructed to wear this for the duration of the study to track activity levels. Participants in the intervention group will be required to upload their diabetes devices to Tidepool each week for the duration of the study. Tidepool is program used at Yale Pediatric Diabetes clinics as the current standard of care for uploading devices (pumps, CGMs, Bluetooth enabled pens) in our clinics and is HIPAA compliant. Participants may contact the Yale Diabetes Team for insulin dose adjustments or the study team at any point during the study if they have a question about the study.
Visit 2 (Week 13) & Visit 3 (Week 26): At these visits, all participants will meet with a diabetes care provider who will carry out a comprehensive review of diabetes management and review blood glucose and insulin records. Diabetes devices will be downloaded, and glycemic trends and insulin dosing regimens will be reviewed. The treatment regimen will be adjusted as clinically indicated.
After 26 weeks in the study, intervention group parents will be asked to participate in focus groups to discuss the study. These meetings will take place at the Yale Pediatric Diabetes Research Center.
研究类型
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
i. Clinical diagnosis of type 1 diabetes for at least 1 year ii. Ages 7-21 years iii. Participants 18 years of age must be able to read and provide written consent iv. Participants under 18 years of age must be able to read and provide written assent v. Participants are managed using an insulin pump or multiple daily injections vi. Participant has a CGM or is willing to wear a CGM for the duration of the study
Exclusion Criteria:
I. Hemoglobin A1c <7.5% or > 10.0% ii. Recent history of more than 1 episode of diabetic ketoacidosis (DKA) in the past 4 months iii. Treatment with glucose lowering drugs other than insulin iv. Females who are pregnant, lactating, or planning to become pregnant in the next 6 months v. Another medical condition that precludes participation in the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Automated Insulin Dose Adjustment (AIDA)
Using the AIDA system to assist the parents of children with T1D make insulin dose adjustments
|
The system originally developed at Boston Children's Hospital, obtains CGM, insulin delivery, and activity data, from the cloud each day at approximately 8:00 PM using an Application Program Interface (API) calls to commercial companies (primarily Glooko and Tidepool) that aggregate data from different devices used to manage glucose levels in individuals.
A detailed statistical and control analysis (see preliminary data study 1 for algorithm details) of the data are then conducted to determine if a change in therapy is required.
If the analysis indicates a change in therapy is required, the patient or parent is notified by text or email directing then to a web portal detailing the change.
The patient or parent can accept or modify the recommended change.
If a change is made, the AIDA system confirms that the change is correctly implemented into the patient's pump or Bluetooth enabled pen when the patient next uploads the device data to the cloud.
|
|
有源比较器：Control
Standard Care - change in therapy settings effected a regularly scheduled patients visits
|
Standard Care - change in therapy settings effected at regularly scheduled patient visits
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent of patients at target range from baseline to 13 week
大体时间：13 weeks
|
Based on continuous glucose monitoring.
Target range is defined as 70- 180 mg/dL
|
13 weeks
|
|
Percent of patients at target range from baseline to 26 weeks
大体时间：26 weeks
|
Based on continuous glucose monitoring.
Target range is defined as 70- 180 mg/dL
|
26 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in HbA1c
大体时间：13 weeks
|
This outcome will determine if there was a change in HbA1c levels from baseline to 13 weeks based on continuous glucose monitoring
|
13 weeks
|
|
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
大体时间：Baseline
|
Based on continuous glucose monitoring
|
Baseline
|
|
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
大体时间：13 week
|
Based on continuous glucose monitoring
|
13 week
|
|
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
大体时间：26 week
|
Based on continuous glucose monitoring
|
26 week
|
|
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
大体时间：Baseline
|
Frequency of nighttime hypoglycemic events
|
Baseline
|
|
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
大体时间：13 week
|
Frequency of nighttime hypoglycemic events
|
13 week
|
|
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
大体时间：26 week
|
Frequency of nighttime hypoglycemic events
|
26 week
|
|
Percent of the recommendations that are accepted or modified by the family
大体时间：26 week
|
Percent of the recommendations that are accepted or modified by the family
|
26 week
|
|
Hypoglycemia Fear Survey
大体时间：26 weeks
|
This will be administered to the child and parent.
The survey consists of 23 questions.
Questions are answered using a 5 point likert scale ranging from never, rarely, sometimes, often, and always.
The administration time is 10 minutes.
The higher scores entail greater worry.
|
26 weeks
|
|
Pittsburgh Sleep Quality Survey (PSQI)
大体时间：26 weeks
|
The survey consists of 10 questions.
The Questions relate to usual sleep habits over the last month, including time it takes to fall asleep, usual bedtime, hours of sleep per night, as well as questions about the frequency of sleep issues (not during the past month, less than once per week, once or twice per week, or three or more times per week).
Higher scores suggest poorer sleep quality.
The administration time is 5 minutes.
|
26 weeks
|
|
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
大体时间：26 weeks
|
This will be administered to the parent and teen.
The survey consists of 12-24 questions that are based on a likert scale ranging from 0 to 6. Higher scores entail greater satisfaction.
The administration time is 10 minutes.
|
26 weeks
|
|
Problem Areas in Diabetes Scale (PAID)
大体时间：26 weeks
|
This is a questionnaire with 20 questions scaled from 0 to 4 on a likert scale.
Questions involve feelings and emotional distress related to diabetes.
Higher scores entail a more serious problem related to diabetes.
The Administration time is 5 minutes.
|
26 weeks
|
合作者和调查者
调查人员
- 首席研究员：Laura Nally, MD、Yale University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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