Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Non-inferiority of mean CGM between FCL and Usual Care
研究概览
简要总结
AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).
详细描述
This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 years. This includes use of new features allowing requested correction boluses and setting a tighter glycemia goal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥6.0 and ≤13 years old at time of consent
- •Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- •Currently using insulin pump for at least three months; Any pump, either open loop or hybrid closed loop may be used.
- •Currently using insulin for at least six months.
- •Willingness to use lispro/aspart in the insulin pump during the study.
- •Currently using a Dexcom G6 or G7 CGM.
- •Has one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that live with participant.
- •Participant not currently known to be pregnant or breastfeeding.
- •If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- •Willingness to use the study FCL system (CGM, pump, and phone) during the relevant study period.
- •Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
- •Willingness to participate in all study procedures including the house/hotel session and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session.
- •Access to internet at-home and willingness to upload data during the study as needed.
- •Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
- •Participant is proficient in reading and writing English.
排除标准
- •Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
- •Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic Diabetic ketoacidosis (DKA).
- •Hemophilia or any other bleeding disorder.
- •History of severe hypoglycemic events with seizure or loss of consciousness in the last 6 months.
- •History of diabetic ketoacidosis (DKA) event in the last 6 months.
- •History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis.
- •History of adrenal insufficiency.
- •Currently being treated for a seizure disorder.
- •Hypothyroidism or hyperthyroidism that is not adequately treated.
- •Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise.
- •Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
- •Planned surgery during the study period.
- •Known ongoing adhesive intolerance that is not well managed.
- •A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
- •Participation in another interventional trial at the time of enrollment.
- •Participant with a direct supervisor involved in the conduct of the trial.
研究组 & 干预措施
Usual Care before experimental system; system with Normal Glycemia Goal
Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal.
干预措施: Normal Glycemia Goal (Device)
Usual Care before experimental system; system with Tight Glycemia Goal
Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal.
干预措施: Tight Glycemia Goal (Device)
Usual Care after experimental system; system with Normal Glycemia Goal
Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal.
干预措施: Normal Glycemia Goal (Device)
Usual Care after experimental system; system with Tight Glycemia Goal
Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal.
干预措施: Tight Glycemia Goal (Device)
结局指标
主要结局
Non-inferiority of mean CGM between FCL and Usual Care
时间窗: 28 days
Non-inferiority of the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
次要结局
- GMI derived from mean CGM(28 days)
- Time in range 70-180 mg/dL(28 days)
- CGM standard deviation (StDev)(28)
- CGM coefficient of variation (CV)(28 days)
- CGM %<54 mg/dL(28 days)
- CGM %<70 mg/dL(28 days)
- CGM %>180 mg/dL(28 days)
- CGM %>250 mg/dL(28 days)
- Non-inferiority of mean CGM between Normal Glycemia Goal and Tight Glycemia Goal(17 days)
研究者
Mark D. DeBoer, MD, MSc., MCR
Principal Investigator
University of Virginia