A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Time in Range (70-180 mg/dL)
研究概览
简要总结
A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.
详细描述
This study is a randomized cross-over trial comparing AIDANET used in three different modalities to currently available AID systems (usual care). For two 4-week phases the participants will first use the system in predetermined modality (HCL or FCL) in random order. The AIDANET system is designed to work both in full closed loop (no meal information) and in hybrid closed-loop, with carbohydrate announcement (standard bolus calculator) or easy bolus (announce timing but not carbohydrate amount), as requested by the user. During a third 4-week long phase, all participants will continue to use the system as befits their preferences (no modality will be imposed, and the user is free to go back and forth between modalities). In addition, the participant will spend 4 weeks using a usual care AID system either before the first AIDANET phase (randomization Group A) or after the last AIDANET phase (randomization Group B).
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
- •Age ≥18.0 years old at time of consent
- •Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
- •Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).
- •Currently using insulin for at least six 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 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 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 four 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 course of 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 is capable of adhering to the protocol.
- •Participant is proficient in reading and verbal communication in English.
排除标准
- •Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month.
- •Current use of sulfonylurea medications.
- •Current use of an Sodium-Glucose Cotransporter 2 (also known as a 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 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 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
Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix
干预措施: AIDANET + FCL (Device)
Group A
Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix
干预措施: AIDANET in FCL-HCL-mixed mode (Device)
Group B
Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID
干预措施: AIDANET + FCL (Device)
Group B
Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID
干预措施: AIDANET + HCL (Device)
Group B
Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID
干预措施: AIDANET in FCL-HCL-mixed mode (Device)
Group B
Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID
干预措施: Automated Insulin Delivery (AID) (usual care) (Other)
Group A
Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix
干预措施: AIDANET + HCL (Device)
Group A
Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix
干预措施: Automated Insulin Delivery (AID) (usual care) (Other)
结局指标
主要结局
Time in Range (70-180 mg/dL)
时间窗: 16 weeks
* Computed as the number of estimated glucose values ≥70mg/dL and \<180mg/dL divided by the number of valid values (defined as a number between 39 and 401) * Outcome is computed if: * \>4032 values are recorded (availability condition, 2 weeks equivalent) * AND there is \>70% values between the first recorded EGV of the analysis window and the last (density condition)
Time in Range (70-180 mg/dL)
时间窗: 16 weeks
* Computed as the number of estimated glucose values ≥70mg/dL and \<180mg/dL divided by the number of valid values (defined as a number between 39 and 401) * Outcome is computed if: * \>4032 values are recorded (availability condition, 2 weeks equivalent) * AND there is \>70% values between the first recorded EGV of the analysis window and the last (density condition)
次要结局
未报告次要终点
研究者
Sue Brown
Principal Investigator
University of Virginia