Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy (PANORAMA): Randomized Controlled Crossover Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time in range
研究概览
简要总结
In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.
The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, [IQR 71.05%-82.61%] vs. 57.38% [IQR 52.38%-81.35%], p=0.03).
Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.
The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over.
详细描述
Rationale:
Insulin dependent diabetes after total pancreatectomy (TP) is difficult to manage due to the complete absence of alfa and beta cells. In a recent pilot study in 10 patients after total pancreatectomy, treatment with a bihormonal closed loop system was safe and resulted in better glucose control compared to current open loop therapy.
Objective:
To assess the efficacy of a 3-month treatment with a bihormonal artificial pancreas (BIHAP) in patients after total pancreatectomy compared to current diabetes care.
Secondary objectives are to assess the safety of BIHAP treatment; quality of life during BIHAP treatment and additional efficacy parameters.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Age ≥18 years
- •Insulin dependent diabetes after total pancreatectomy (patients who previously participated in APPEL 5+ are allowed to be included)
- •At least three months after total pancreatectomy
- •Patients using flash or continuous glucose sensor (Free Style Libre, Guardian or Medtronic) ,willing to scan this sensor at least three times per day during the control period and to remove this sensor during BIHAP treatment
- •Undergoing treatment with CSII or subcutaneous insulin injections.
排除标准
- •Known or suspected allergy to trial product(s) or related products;
- •Suboptimal clinical condition, for instance due to active postoperative surgical complications, including skin condition prohibiting needle insertion;
- •Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment;
- •Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening for other clinical trial related purposes;
- •Current treatment with chemotherapy or when used less than 3 months prior to screening;
- •BMI > 35 kg/m2;
- •HbA1c > 97 mmol/ml (=11.0 %);
- •Use of oral glucose-lowering medication;
- •Limited ability to see, and to hear or feel alarms signals of the BIHAP;
- •Use of acetaminophen (paracetamol) during the use of the BIHAP, as this may influence the sensor glucose measurements.
- •Current pregnancy, breast feeding or planning to become pregnant during the trial or using ineffective birth control methods;
- •Patients with a concomitant disease affecting metabolic control;
- •Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handing over diabetes control to a device or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant.
结局指标
主要结局
Time in range
时间窗: During open and closed loop treatment (both 3 months)
Time spent in euglycemia (glucose value 3.9-10.0 mmol/l or 70-180mg/dL) during BIHAP treatment
次要结局
- Efficacy of open and closed loop system(During open and closed loop treatment (both 3 months))
- Adverse events and device issues associated with closed loop system with BIHAP(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - HFS-II(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - WHO-5(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - EQ-5D-5L(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - DTSQc andDTSQs(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - PAID-20(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - PSQI(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - INSPIRE(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - Hypoglycaemia unawareness(During open and closed loop treatment (both 3 months))
- Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment(During open and closed loop treatment (both 3 months))
研究者
M.G. Besselink
Marc Besselink, Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)