Efficacy and Safety of Medtronic 780G Automated Insulin Delivery System in Adults With Type 1 Diabetes and Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The primary efficacy endpoint is the change in percentage of time in range (TIR; sensor glucose 70-180 mg/dL) from baseline to 3 months. The main comparison focuses on the between-group difference in this change from baseline.
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of Medtronic 780G automated insulin delivery system in adult persons with type 1 diabetes and gastroparesis.
详细描述
STUDY OBJECTIVE To evaluate efficacy (change in time spent in 70-180 mg/dL, TIR) and safety of Medtronic 780 G compared to usual care in adults with T1D and gastroparesis.
OUTCOMES
Primary outcome Time spent in sensor glucose of 70-180 mg/dL
Secondary outcomes
- HbA1c
- Mean glucose
- Percent time spent in sensor glucose range of 70-140 mg/dL (time in tight target range; TTIR)
- Percent time spent in sensor glucose >180 mg/dL and >250 mg/dL
- Percent time spent in sensor glucose<70 mg/dL and <54 mg/dL
- Glucose variability (standard deviation (SD) of glucose)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of T1D for at least 12 months with stable insulin regimen for at least 2 months
- •HbA1c ≥8.0%
- •Diagnosis of gastroparesis per National Institute of Health (NIH) definition
- •Willing to use Medtronic 780G system either with Simplera CGM.
- •Ability to provide informed consent before any trial-related activities
- •If randomized to usual care group and on an insulin pump already, should be willing to use pump in manual mode only for the duration of the study
排除标准
- •Age <18 years
- •Current use of inhaled insulin (Afrezza)
- •Patients with T1D using any glucose lowering medications other than insulin at the time of screening
- •Pregnancy, breast feeding, or wanting to become pregnant
- •Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period
- •History of gastric outlet obstruction or other gastrointestinal structural abnormalities
- •Estimated glomerular filtration rate (eGFR) <30 or on dialysis
- •History of SH in the previous 3 months
- •History of two or more episodes DKA requiring hospitalization in the past 12 months
- •Any medical (such as severe cardiovascular disease, malignancy, chronic liver disease) or psychosocial conditions that make a person unfit for the study at the discretion of investigators
- •Use of investigational drugs within 5 half-lives prior to screening
- •Current use of cannabis or history of cannabinoid hyperemesis syndrome
研究组 & 干预措施
Medtronic 780G group
干预措施: Medtronic 780G AID (Device)
Usual care
Participants will continue either multiple daily injections or non-AID insulin pumps
结局指标
主要结局
The primary efficacy endpoint is the change in percentage of time in range (TIR; sensor glucose 70-180 mg/dL) from baseline to 3 months. The main comparison focuses on the between-group difference in this change from baseline.
时间窗: 3months
Time in Range (70-180 mg/dL)
时间窗: Baseline to 3 months
Percentage of time that sensor glucose values are within the target range of 70-180 mg/dL, as measured by continuous glucose monitoring (CGM).
次要结局
- Glucose Variability(Baseline to 3 months)
- HbA1c(Baseline to 3 months)
- Mean Sensor Glucose(Baseline to 3 months)
- Time in Tight Target Range (70-140 mg/dL)(Baseline to 3 months)
- Time Above Range(Baseline to 3 months)
- Time Below Range(Baseline to 3 months)
研究者
Viral N. Shah
Principal Investigator
Indiana University School of Medicine