NCT07325461已完成不适用
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
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
- 20
- 试验地点
- 1
- 主要终点
- 7 Day Survival of Infusion Set for Primary Outcome Measure
研究概览
简要总结
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
详细描述
All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each.
The 2 treatment arms are:
Existing t:slim X2 Users:
- t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
- t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods)
Existing Mobi Users:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 80 years old inclusive
- •Generally in good health, as determined by the investigator
- •Living in the United States with no plans to move outside the United States during the study
- •Diagnosis of T1D for at least 12 months
- •Currently using a Tandem pump
- •Current Dexcom CGM user
- •HbA1c <9.0% in the last 6 months.
- •Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
- •Willing to wear each investigational infusion set for up to 7 days during each of the wear periods in the study
- •Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
- •If using Tandem Mobi, has a compatible cellular phone that can run the Tandem Mobi Mobile App
- •BMI in the range 18-35 kg/m2, both inclusive
- •Currently using one of the following insulins with no expectation of a need to change insulin type during the study:
- •Humalog™ (or generic insulin lispro)
- •NovoLog™ (or generic insulin aspart)
- •Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
- •Has the ability to understand and comply with protocol procedures and to provide informed consent
排除标准
- •Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
- •Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception
- •Episodes of severe hypoglycemia in the last 6 months resulting in:
- •Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
- •Loss of consciousness
- •One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
- •Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period
- •Known history of any of the following conditions:
- •Cushing's Disease
- •Adrenal insufficiency
- •Pancreatic islet cell tumor
- •Lipodystrophy
- •Extensive lipohypertrophy, as assessed by the investigator
- •Undergoing treatment with systemic oral or intravenous corticosteroids, at or within the last 8 weeks from screening. Inhaled glucocorticoids are allowed.
- •Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
- •Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
- •Current participation in another clinical drug or device study
- •Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care
研究组 & 干预措施
Mobi Users
Experimental
- Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)
- Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
干预措施: SteadiSet Infusion Set (Device)
t:slim X2 Users
Experimental
- t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
- t:slim X2 with and SteadiSet (43 inches) with no side ports (3 wear periods)
干预措施: SteadiSet Infusion Set (Device)
结局指标
主要结局
7 Day Survival of Infusion Set for Primary Outcome Measure
时间窗: 6 weeks
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised)
次要结局
未报告次要终点
研究者
研究点 (1)
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