Safety and Feasibility Testing of a Smaller Network Version of AIDANET (MiniNET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home.
研究概览
简要总结
A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).
详细描述
The study will be performed for about 36 hours at a local hotel. Following the hotel session, participants will undergo a 7 day/6-night Remote Monitored At-Home use session. A one-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy will also be completed. Participants will be randomized 1:1, to either Group A (control period prior to AIDANET use) or Group B (control period after AIDANET use).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18.0 and ≤60 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 switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team.
- •Currently using a Dexcom G6 or G7 CGM.
- •Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that 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 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, exercise challenges (e.g., one hour per day during hotel), 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 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.
- •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→AIDANET
Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights.
干预措施: AIDANET (Device)
AIDANET→Usual Care
Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment.
干预措施: AIDANET (Device)
结局指标
主要结局
Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home.
时间窗: 2 weeks
This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered. Nevertheless, the randomized crossover design will allow for analysis of period effects between Group A and Group B. Comparison between these groups will be made to determine if a period effect can explain part of the benefit of the FCL system during the at-home period.
次要结局
- Difference in Percent Time-in-range(2 weeks)
- Difference in Percent Time-below-range(2 weeks)
- Difference in Percent Time-in-tight-range(2 weeks)
研究者
Marc Breton
Professor
University of Virginia