The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Time in Range
研究概览
简要总结
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
详细描述
Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a "closed-loop" system.
This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic.
A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months
- •Familiarity and use of a carbohydrate ratio for meal boluses.
- •Age ≥2 and <6 years old
- •Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
- •Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
- •Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study-provided Tandem pump during the study.
- •Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart
- •Total daily insulin dose (TDD) at least 5 U/day
- •Body weight at least 20 lbs.
- •Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3)
- •Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
- •Parent/guardian proficient in reading and writing English.
排除标准
- •Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 [GLP-1] agonists, Symlin, Dipeptidyl peptidase-4 [DPP-4] inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors, sulfonylureas).
- •Hemophilia or any other bleeding disorder
- •History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
- •History of >1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
- •History of chronic renal disease or currently on hemodialysis
- •History of adrenal insufficiency
- •Hypothyroidism that is not adequately treated
- •Use of oral or injectable steroids within the last 8 weeks
- •Known, ongoing adhesive intolerance
- •Plans to receive blood transfusions or erythropoietin injections during the course of the study
- •A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified in the study procedure manual)
- •Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM
- •Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- •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
结局指标
主要结局
Time in Range
时间窗: 13 weeks
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
次要结局
- CGM-measured Mean Glucose(13 weeks)
- HbA1c at 13 Weeks(13 weeks)
- CGM-measured Percent Below 70 mg/dL(13 weeks)
- CGM-measured Percent Above 250 mg/dL(13 weeks)
- CGM-measured Percent Below 54 mg/dL(13 weeks)
研究者
Marc Breton
Principal Investigator
University of Virginia