Tandem Freedom - Feasibility Trial 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Severe Hypoglycemia Events
研究概览
简要总结
This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a one week run-in, then will use Tandem Freedom in a supervised hotel setting.
详细描述
After a one week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 4 nights: 1 day with boluses, and 3 days without boluses, in a supervised hotel setting. Participants will perform exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years old
- •Diagnosis of type 1 diabetes for at least 1 year
- •Current Control-IQ user, having been prescribed Control-IQ for at least 3 months
- •HbA1c ≤10%, recorded in the last 3 months
- •Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.
- •Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.
排除标准
- •More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
- •More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
- •Inpatient psychiatric treatment in the past 6 months
- •For Female: Currently pregnant or planning to become pregnant during the time period of study participation
- •A negative pregnancy test will be required for all females of child-bearing potential
- •Counseling on appropriate birth control options will be provided to all females of child-bearing potential
- •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).
- •Hemophilia or any other bleeding disorder
- •Hemoglobinopathy
- •History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
- •History of allergic reaction to Humalog or Novorapid
- •Use of any medications determined by investigator to interfere with study
- •Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
- •Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
- •History of adrenal insufficiency
- •History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
- •History of gastroparesis
- •A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- •Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
- •Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
研究组 & 干预措施
Tandem Freedom
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
干预措施: t:slim X2 insulin pump with Tandem Freedom Algorithm (Device)
结局指标
主要结局
Number of Participants With One or More Severe Hypoglycemia Events
时间窗: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Number of Participants with One or More Severe Hypoglycemia Events (with cognitive impairment such that assistance of another individual is needed for treatment)
Number of Participants With One or More Diabetic Ketoacidosis Events
时间窗: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)
Number of Participants with One or More Diabetic Ketoacidosis events
次要结局
- Median of Mean Glucose (mg/dL)(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Percent Time <54 mg/dL(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Percent Time <70 mg/dL(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Percent Time in Range 70 - 180 mg/dL(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Percent Time in Range > 180 mg/dL(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Percent Time in Range > 250 mg/dL(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Percent Time in Range 70 - 140 mg/dL(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Mean Glucose (mg/dL)(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Glucose Coefficient of Variation (%)(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))
- Glucose Standard Deviation (mg/dL)(Control-IQ Run-in Period (7 days), Tandem Freedom (3 days))