Metabolic Effects of Hybrid Closed-loop Insulin Delivery in People With Diabetes After Pancreatectomy: a Randomized Cross-over Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Percentage of time in range
研究概览
简要总结
Individuals with diabetes secondary to pancreatectomy experience impaired quality of life, partly due to the challenges of managing highly variable blood glucose levels. Hybrid closed-loop (HCL) automated insulin delivery (AID) systems, widely evaluated in type 1 diabetes, may improve both metabolic outcomes and quality of life in this population.
A review of the literature identified a few observational studies reporting promising results with HCL systems in the context of post-pancreatectomy diabetes. Only one randomized trial has evaluated AID in this population, showing excellent outcomes, but using a complex bihormonal system that is not yet commercially available worldwide. Consequently, there remains a lack of confirmatory evidence regarding the efficacy of commercially available monohormonal HCL systems in individuals with diabetes secondary to pancreatectomy, evidence that is crucial to support broader access to this technology.
The intervention will consist in a 3-month AID treatment combining MiniMed 780 and Simplera.
The control period will consist in 3 months using the Simplera for continuous glucose monitoring, alongside participant usual diabetes treatment.
The primary outcome is the percentage of time that interstitial glucose levels remain within the target range (70-180 mg/dL), as measured by continuous glucose monitoring (CGM, Simplera), over a 3-month period using the MiniMed 780 hybrid closed-loop system, compared to a 3-month period under the participant's usual diabetes treatment.
详细描述
The MiniMed 780G system comprises an external insulin pump with a subcutaneous infusion catheter inserted by the participant using a dedicated insertion kit. The infusion set is placed in the abdomen, buttocks, thighs, or upper arms, following standard hygiene procedures.
The Simplera system consists of an all-in-one external continuous glucose sensor inserted subcutaneously in the back of the upper arm via a dedicated insertion device.
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 from 18 years
- •History of total or partial pancreatectomy with random C-peptide < 0.3 ng/mL and concomitant blood glucose between 120 and 225 mg/dL (no minimum delay required since surgery)
- •Total daily insulin dose between 6 units and 250 units
- •Be affiliated to a French social security scheme
- •Individual able and willing to provide written informed consent
排除标准
- •Presence of diabetic retinopathy at or beyond severe non-proliferative diabetic retinopathy, not stabilized by ophthalmologic treatment
- •Usual diabetes treatment with an insulin pump coupled with continuous glucose monitoring with a "suspend before hypoglycemia" system
- •Pregnant woman or planned pregnancy within the next 6 months
- •Ongoing or planned chemotherapy that interferes or is expected to interfere with glycemic control or nutritional intake, particularly in cases of clinically significant gastrointestinal toxicity and/or associated systemic corticosteroid therapy, after consultation with the treating oncologist.
- •Enteral or parenteral nutrition
- •Estimated life expectancy less than 12 months
- •Cognitive or psychiatric disorders compromising the individual's autonomy to manage automated insulin delivery
- •Person taking part in another research study or with an exclusion period still in progress
- •Individual under legal guardianship or curatorship
- •Any contraindication mentioned in the instructions for use of the MiniMed 780 - Simplera
- •Imprisoned or otherwise deprived of liberty
研究组 & 干预措施
Sequence 1: MiniMed 780 then usual diabetes treatment
干预措施: MiniMed 780 associated with Simplera (Device)
Sequence 2: Usual diabetes treatment then MiniMed 780
干预措施: MiniMed 780 associated with Simplera (Device)
结局指标
主要结局
Percentage of time in range
时间窗: At 3 months
Percentage of time that interstitial glucose levels remain within the target range (70-180 mg/dL), as measured by continuous glucose monitoring (CGM, Simplera), over a 3-month period using the MiniMed 780 hybrid closed-loop system compared to a 3-month period with participant's usual diabetes treatment.
次要结局
- HbA1c(At 3 months)
- Percentage of time below range(At 3 months)
- Glucose coefficient of variation(At 3 months)
- Frequency of acute metabolic events(At 3 months)