ACTRN12620000021976招募中未知
Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1) Participant is 18 – 70 years of age inclusive
- •2) Participant is in generally good health, as determined by the investigator
- •3) Participant is willing and able to individually complete written informed consent and
- •agrees to comply with all study related testing and examinations
- •4) 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
- •5) Participant has been diagnosed with T1DM for at least 12 months
- •6) C-peptide less than 0.6 nmol per L at screening
- •7) Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump
- •use compliance
- •8) 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
- •9) Participant has BMI in the range 20 – 35 kg per square metre inclusive
- •10) Participant has experience infusing a rapid-acting insulin analog for at least 6 months
- •11) Participant has been using an insulin pump with commercially available infusion sets for
- •at least 6 months (this includes Automated Insulin Delivery systems)
- •12) 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
- •13) Participant has ability to understand and comply with protocol procedures and to
- •provide informed consent
- •14) AST and ALT less than or equal to 120 U per L
- •15) Creatinine less than 1.8 mg per dL
排除标准
- •1) 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)
- •2) Participants who routinely change their commercial insulin infusion sets twice weekly or
- •less often (wear time greater than 3.5 days)
- •3) 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.)
- •4) Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
- •5) Participant has HbA1C greater than 8.5 percent at screening
- •6) 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.
- •7) Participant has a history of diabetic ketoacidosis in the last 6 months
- •8) Participant has known cardiovascular disease considered to be clinically relevant by the investigator
- •9) Participant has known arrhythmias considered to be clinically relevant by the investigator
- •10) Participant has known history of:
- •a) Cushing’s Disease,
- •b) pancreatic islet cell tumor, or
- •c) insulinoma
- •11) Participant has:
- •a) Lipodystrophy,
- •b) extensive lipohypertrophy, as assessed by the investigator
- •12) Participant is undergoing current treatment with:
- •a) Systemic oral or intravenous corticosteroids,
- •b) monoamine oxidase (MAO) inhibitors,
- •c) non-selective beta-blockers,
- •d) growth hormone,
- •e) thyroid hormones, unless use has been stable during the past 3 months
- •13) 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:
- •a) Alcoholism,
- •b) drug abuse
- •14) Significant acute or chronic illness, that in the investigator’s opinion, might interfere
- •with subject safety or integrity of study results
- •15) Planned operation, MRI or CT which require removal of infusion set or CGM sensor
- •during wear periods
- •16) Current participation in another clinical drug or device study
- •17) AST and ALT greater than 120 U per L
- •18) Creatinine equal to or greater than 1.8 mg per dL
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