Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of Infusion Set Survival at End of Day 7
研究概览
简要总结
Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion.
This study will include 20 participants and has 3 periods:
Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device.
Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.
详细描述
This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).
The CapBio Achilles infusion set is a sterile single use device designed to be used with commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and three proximal holes.
The primary objective of this study is to determine feasibility and device performance of the CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Participant is 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 less than 0.6 nmol per L at screening
- •Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
- •Participant is willing to perform serum ketone measurements whenever the blood glucose is determined to be greater than 250 mg per dL (14 mmol per L) using a ketone meter and strips provided by the sponsor
- •Participant has BMI in the range 20 - 35 kg per square metre inclusive
- •Participant has experience infusing a rapid-acting insulin analog for at least 6 months
- •Participant has been using an insulin pump with commercially available infusion sets for at least 6 months (this includes Automated Insulin Delivery systems)
- •Participant has previous experience using a continuous glucose monitor (CGM) and is willing to use a CGM for the duration of the study and perform necessary calibration fingerstick glucose readings
- •Participant has ability to understand and comply with protocol procedures and to provide informed consent
- •AST and ALT less than or equal to 120 U per L
- •Creatinine less than 1.8 mg per dL
排除标准
- •Participants whose average total daily insulin dose exceeds 85 units per day (i.e. typically change insulin reservoirs more often than every 3.5 days on average)
- •Participants who routinely change their commercial insulin infusion sets twice weekly or less often (wear time greater than 3.5 days)
- •Female participant is pregnant or nursing (Documented negative pregnancy test results for female participants required unless participant is menopausal without any spontaneous menstrual cycles for >12 months or key organs have been removed.)
- •Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
- •Participant has HbA1C greater than 8.5 percent 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 beta-blockers,
- •growth hormone,
- •thyroid hormones, unless use has been stable during the past 3 months
- •Subject has significant history of any of the following, that in the opinion of the investigator would compromise the subject's safety or successful study participation:
- •Alcoholism,
- •Significant acute or chronic illness, that in the investigator's opinion, might interfere with subject safety or integrity of study results
- •Planned operation, MRI or CT which require removal of infusion set or CGM sensor during wear periods
- •Current participation in another clinical drug or device study
- •AST and ALT greater than 120 U per L
- •Creatinine equal to or greater than 1.8 mg per dL -
结局指标
主要结局
Rate of Infusion Set Survival at End of Day 7
时间窗: 7 days during weeks 2 and 3
The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.
次要结局
未报告次要终点