Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of infusion set failures due to "unexplained hyperglycemia"
研究概览
简要总结
This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes
详细描述
This study will compare use of a standard infusion set with an extended wear infusion set. Subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. The order of infusion set wear will be randomized with the first set wear. The investigators aim to see whether there is a benefit to using an extended wear infusion set.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Clinical diagnosis of type 1 diabetes for more than one year, using an insulin infusion pump for at least 6 months, and using the 670G pump for at least 3 months
- •Age ≥18 years
- •Using Novolog or Humalog insulin at time of enrollment
- •For females, not currently known to be pregnant
- •An understanding of and willingness to follow the protocol and sign the informed consent
- •Willing to have photographs taken of their infusion sites
- •Willing to download their 670G pump every week to a research Carelink account
- •Willing to submit a brief online questionnaire at the time of any infusion set failure
- •Able to understand spoken or written English
- •Hemoglobin A1c <8.5% at the time of enrollment
- •Willing to perform three or more fingerstick glucose measurements each day
- •Willing to sign a consent for release of medical information at the time of enrollment
- •Willing to change their infusion pump insulin reservoirs at least every 6 days
排除标准
- •Hypoglycemic seizure or loss of consciousness in the past 6 months
- •Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
- •A known cardiovascular disease
- •Active proliferative diabetic retinopathy
- •Known tape allergy
- •Current treatment for a seizure disorder
- •Cystic fibrosis
- •Active infection
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- •Inpatient psychiatric treatment in the past 6 months
- •Presence of a known adrenal disorder
- •If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the last 2 months prior to enrollment in the study
- •Abuse of alcohol
- •History of dialysis, renal failure or known eGFR <60 ml/min/1.73m2
- •Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment
结局指标
主要结局
Number of infusion set failures due to "unexplained hyperglycemia"
时间窗: 14 days for each type of infusion set, with each type of infusion set worn twice
Defined as: 1. Glucose \>250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL 2. Ketones ≥0.6 mg/dL with a glucose reading of \>250 mg/dL (in the absence of illness) 3. Evidence of infection at the infusion site (erythema or induration \>1cm in diameter) 4. Pump occlusion alarm
次要结局
- Duration of infusion set wear(14 days for each type of infusion set, with each type of infusion set worn twice)
研究者
Bruce Buckingham
Professor Emeritus, Pediatrics - Endocrinology and Diabetes
Stanford University