Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time in range 70-140 mg/dL as computed by the study CGM
研究概览
简要总结
This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.
详细描述
The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL).
The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant Inclusion Criteria
- •Age ≥18.0 years old at time of consent
- •Clinical diagnosis, based on investigator assessment, of T1D for > 1 year.
- •Having used an FDA approved AID system within the last 6 months (can be intermittent use).
- •Currently using insulin for >6 months.
- •Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.
- •Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
- •Participant not currently known to be pregnant or breastfeeding.
- •If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants 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 wear a Dexcom CGM during each of the study phases.
- •Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
- •Willingness not to start any new non-insulin glucose-lowering agent during the trial.
- •Willingness to participate in all study procedures including in person training.
- •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 can adhere to the protocol.
- •Participant is proficient in reading and verbal communication in English.
- •Participant
排除标准
- •The participant must not have any exclusion criteria to be eligible to participate in the study.
- •Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.
- •Current use of sulfonylurea medications.
- •Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.
- •Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
- •Hemophilia or any other bleeding disorder.
- •History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
- •History of DKA event in the last 12 months.
- •Currently on peritoneal or hemodialysis.
- •Currently being treated for adrenal insufficiency.
- •Currently being treated for a seizure disorder.
- •Hypothyroidism or hyperthyroidism that is not adequately treated.
- •Use of oral or injectable steroids at the time of enrollment.
- •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 at work/school who is involved in the conduct of the trial.
研究组 & 干预措施
Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL)
干预措施: Automated Insulin Delivery (AID) (Device)
Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL)
干预措施: AIDANET + Fully Closed Loop (FCL) (Device)
Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL)
干预措施: AIDANET + Anticipatory Closed Loop (ACL) (Device)
Group B: AID first followed by AIDANET+FCL then AIDANET+ACL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL).
干预措施: Automated Insulin Delivery (AID) (Device)
Group B: AID first followed by AIDANET+FCL then AIDANET+ACL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL).
干预措施: AIDANET + Fully Closed Loop (FCL) (Device)
Group B: AID first followed by AIDANET+FCL then AIDANET+ACL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL).
干预措施: AIDANET + Anticipatory Closed Loop (ACL) (Device)
结局指标
主要结局
Time in range 70-140 mg/dL as computed by the study CGM
时间窗: 8 weeks
Computed as the number of estimated glucose values ≥70mg/dL and \<140mg/dL divided by the number of valid values (defined as a number between 39 and 401)
次要结局
未报告次要终点
研究者
Sue Brown
Study Principal Investigator
University of Virginia