NCT04398030已完成不适用
Randomized Crossover Euglycemic Clamp Study in Adult Patients With T1DM to Assess Pharmacokinetics and Pharmacodynamics of Subcutaneously Infused Insulin Using an Investigational Extended Wear Continuous Subcutaneous Insulin Infusion Cannula Compared to a Commercial Infusion Set
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The Primary Endpoint is the Rate of Decline (s) Over Wear Time (DOI, Day 3, Day 5, Day 7) of the Natural Logarithm of the Area Under the Glucose Infusion Rate Curve [ln (AUC0-300(GIR))].
研究概览
简要总结
This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a wash-out period, subjects will cross over into the investigational or control group, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Participants are 18 - 70 years of age inclusive
- •Participant is in generally good health, as determined by the investigator
- •Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations
- •Participant must be geographically stable (e.g., expects to be available and capable of returning for all study specified test and examinations) during the study period
- •Participant has been diagnosed with T1DM for at least 12 months
- •C-peptide <0.6 nmol/L at screening
- •Participant has been using insulin pump therapy for at least 6 months and is currently using a Medtronic MiniMed pump, model series 530 or higher. Use of 670G in auto mode is acceptable.
- •Participant can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
- •Participant is willing to perform frequent (4 times per day or more) self-monitoring of blood glucose (SMBG), including before meals and before bed, and using a meter and test strips provided by the sponsor during the two weeks of active treatment. This includes participants who are currently using real-time continuous glucose monitoring and may continue to do so, but must also collect SMBG values as instructed.
- •Participant is willing to perform serum ketone measurements whenever the blood glucose is determined to be greater than 250 mg/dL after extended fasting (e.g. overnight or more than five hours after a meal) using a ketone meter and strips provided by the sponsor
- •Participant has BMI in the range 20 - 35 kg/m2 inclusive
- •Participant has experience infusing a rapid-acting insulin analog for at least 6 months
- •Participant has been using or is willing to use a Continuous Glucose Monitor (CGM) (reading data available for at least 80% of time for a week of data collection during the screening period). Participants already using - Dexcom G6 real time CGM may continue to use their own CGM unit; participants not using the G6 will be provided with a G6 monitor. All participants will be provided with CGM disposables for use during the treatment period.
- •Participant has ability to understand and comply with protocol procedures and to provide informed consent
- •HbA1c ≤8.5%
- •Stable body weight in the 3 months prior to enrollment (change in body weight <5%)
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Participants whose average total daily insulin dose exceeds 85 units/day (i.e., typically change insulin reservoirs more often than every 4 days on average)
- •Participants who routinely change their commercial insulin infusion sets on average less often than every 4.5 days
- •Female participant is pregnant or nursing
- •Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
- •Participant has hemoglobin <12.0 g/dL or potassium < 3.5 milliequivalent/L at screening
- •Participant has documented history in last 6 months of severe hypoglycemia associated with cognitive dysfunction sufficiently severe to require third party intervention or a history of impaired awareness of hypoglycemia.
- •Participant has a history of diabetic ketoacidosis in the last 6 months
- •Participant has known cardiovascular disease considered to be clinically relevant by the investigator
- •Participant has known arrhythmias considered to be clinically relevant by the investigator
- •Participant has known history of:
- •Cushing's Disease,
- •Pancreatic islet cell tumor, or
- •Participant has:
- •Lipodystrophy,
- •Extensive lipohypertrophy, as assessed by the investigator
- •Participant is undergoing current treatment with:
- •Systemic oral or intravenous corticosteroids,
- •Monoamine oxidase (MAO) inhibitors,
- •Non-selective systemic beta-blockers,
- •Growth hormone,
- •Thyroid hormones, unless use has been stable during the past 3 months
- •SGLT2 inhibitors
- •Participant has significant history of any of the following, that in the opinion of the investigator would compromise the participant's safety or successful study participation:
- •Alcoholism,
- •Significant acute or chronic illness, that in the investigator's opinion, might interfere with participant safety or integrity of study results
- •Planned operation, MRI or CT which require removal of infusion set or CGM sensor during wear periods
- •Current treatment with systemic (oral or IV) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products that, in the opinion of the investigator, may alter insulin sensitivity or confer undue risk to the participant's participation in the study or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
- •Current participation in another clinical drug or device study
- •Inability of the participant to comply with all study procedures or to understand the participant instructions
研究组 & 干预措施
coil-reinforced soft polymer indwelling cannula
Experimental
Participants in this arm are randomized into the coil-reinforced soft polymer indwelling cannula group and then switched to a soft Teflon indwelling cannula group after a 2-week washout/rest (±1 week). The participant will try to wear each infusion set for 7 consecutive days.
干预措施: coil-reinforced soft polymer indwelling cannula (Device)
soft Teflon indwelling cannula
Active Comparator
Participants in this arm are randomized into the soft Teflon indwelling cannula group and then switched to the coil-reinforced soft polymer indwelling cannula group after a 2-week washout/rest (±1 week). The participant will try to wear each infusion set for 7 consecutive days.
干预措施: soft Teflon indwelling catheter (Device)
结局指标
主要结局
The Primary Endpoint is the Rate of Decline (s) Over Wear Time (DOI, Day 3, Day 5, Day 7) of the Natural Logarithm of the Area Under the Glucose Infusion Rate Curve [ln (AUC0-300(GIR))].
时间窗: 7 days
The primary endpoint will be compared between the treatment groups.
次要结局
- Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)(7 days)
- Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)](7 days)
- Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Late) Maximum Insulin Concentration [t50%(Late)](7 days)
- Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)(7 days)
- Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin(7 days)
- Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300)(7 days)
- Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60(7 days)
研究者
研究点 (1)
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