Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy: To Assess How the 670G System Adapts to the Introduction of Fiasp® Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
研究概览
简要总结
This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.
详细描述
This will be a randomized cross-over blinded study and to see how the 670G pump responds to the introduction of Fiasp® insulin. Subjects enrolled in the study will have a 2 week period of optimization with weekly assessments of their Carelink download before entering the blinded phase of the study. They will use their usual home insulin during the optimization phase. They will then be started on their first blinded insulin (aspart or Fiasp®) which they will use for 2 weeks, before they cross-over to the other insulin.
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
- Double (Participant, Investigator)
盲法说明
Double-blinded
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 and using 670G pump for at least 1 month, and willing to have the 670G pump downloaded into a Carelink Clinical research database.
- •The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
- •Age ≥18 years
- •Using Novolog or Fiasp® insulin at time of enrollment
- •Willing to use Fiasp® insulin
- •Total daily insulin dose is at least 0.3 units/kg/day
- •Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast
- •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 1-2 weeks to a research Carelink account
- •Willingness to answer a brief online questionnaire every 2 weeks
- •Must be able to understand spoken or written English
- •For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care
- •Hemoglobin A1c between 6 and 10% at the time of enrollment
排除标准
- •Pregnant or lactating females
- •No 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
- •No known cardiovascular events in the last 6 months
- •No active proliferative diabetic retinopathy
- •Known tape allergies
- •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, with lack of stability on the medication for the past 2 months prior to enrollment in the study
- •Abuse of alcohol
- •Dialysis or renal failure
- •Known eGFR <60%
- •Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
研究组 & 干预措施
Fiasp then Novolog
Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.
干预措施: Fiasp (Drug)
Fiasp then Novolog
Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.
干预措施: Novolog (Drug)
Novolog then Fiasp
Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.
干预措施: Fiasp (Drug)
Novolog then Fiasp
Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned.
干预措施: Novolog (Drug)
结局指标
主要结局
Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
时间窗: 7 days (during 2nd half of 2-week intervention period)
Percentage of time in range (days) as a measure of hypoglycemia.
Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
时间窗: 7 days (during 2nd half of 2-week intervention period)
Measured as percentage of time in range (days).
次要结局
- Mean Sensor Glucose in mg/dl(7 days (during 2nd half of 2-week intervention period))
研究者
Bruce Buckingham
Professor of Pediatric Endocrinology
Stanford University