The Effect of Fully Closed-loop Insulin Delivery on Renal Oxygenation in People With Type 2 Diabetes and Chronic Kidney Disease: an Open-label, Single-center, Randomized Two-arm Parallel Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Cortical renal tissue oxygenation (R2*)
研究概览
简要总结
The main objective of this study is to evaluate the effect of fully automated closed-loop glucose control on renal tissue oxygenation among people with type 2 diabetes and chronic kidney disease.
This is a single-center, open-label parallel design study that will compare 26 weeks of fully-automated closed-loop glucose control with standard insulin therapy and continuous glucose monitoring, following a run-in period. A total of up to 76 adults with type 2 diabetes and chronic kidney disease will be recruited through outpatient diabetes and nephrology clinics.
The primary outcome is renal tissue oxygenation measured using blood oxygenation level-dependent magnetic resonance imaging at 26 weeks. Other key outcomes include glycated hemoglobin at 26 weeks and time spent with glucose levels within and above the target glucose range (3.9-10.0mmol/L). Other glycemic and renal outcomes (including renal function) will also be assessed, as well as patient-reported outcome measures using validated questionnaires. Safety evaluations include severe hypoglycemic episodes and other adverse and serious adverse events.
详细描述
Recruitment:
The investigators aim to recruit 76 participants through the Service of Endocrinology, Diabetes, and Metabolism and through the Nephrology and Hypertension Service at the University Hospital of Lausanne (CHUV), as well as other outpatient diabetes clinics in the canton of Vaud if needed.
Screening visit:
Potential participants will have the opportunity to ask questions and will give written informed consent if interested in participating in the study. A screening blood test, a urine analysis, and urine pregnancy test will be done at this visit.
Baseline visit:
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
- Single (Outcomes Assessor)
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
- •Informed consent signed by the subject
- •Age 18 years and older
- •Type 2 diabetes diagnosed for at least 12 months
- •Treatment with insulin therapy for at least 6 months
- •CKD defined either as an eGFR 30-59 ml/min/1.73m² or presence of albuminuria > 3 mg/mmol (stage A2 or A3 according to KDIGO) with an eGFR > 30 ml/min/1.73m². CKD must be present for at least 6 months.
- •HbA1c < 12% based on a venous blood sample from the screening visit
- •Receiving treatment with an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, have been offered these therapies previously, or contraindication/intolerance to receiving these therapies
- •Willing to wear study devices and follow study instructions
- •Capable of giving an informed consent
排除标准
- •Type 1 diabetes
- •Current use of insulin pump
- •Current use of any closed-loop system
- •Alternative cause of CKD according to medical records such as polycystic kidney disease, glomerulonephritis, congenital urogenital tract diseases, etc.
- •Known or suspected allergy against insulin
- •Pregnancy, planned pregnancy, or breast feeding
- •Severe visual impairment
- •Severe hearing impairment
- •Two or more episodes of severe hypoglycemia in the last 6 months
- •Medically documented allergy towards the adhesive (glue) of plasters
- •Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- •Any physical/psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician
- •Recent (less than three months) history of myocardial infarction, percutaneous coronary intervention, stroke, or hospitalization for heart failure with reduced ejection fraction
- •History of renal transplantation requiring ongoing immunosuppressive therapy
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the investigation, e.g. due to language problems
- •Incapacity to give informed consent
- •Contra-indication to undergo MR-imaging according to a standard checklist such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia.
- •Subject refuses to be informed of incidental findings related to their health discovered during imaging or other study-related exams
- •Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
- •Previous enrolment into the current investigation
- •Enrolment of the PI, his/her family members, employees and other dependent persons
研究组 & 干预措施
Fully closed-loop insulin delivery (CamAPS HX)
The CamAPS HX closed-loop system will consist of :
- mylife Ypsopump insulin pump (Ypsomed, Switzerland)
- FreeStyle Libre 3 CGM (Abbott, USA)
- Cambridge model predictive control algorithm on a smartphone (CamAPS, UK)
- Cloud upload system to review CGM/insulin data
干预措施: CamAPS HX (Device)
Standard insulin therapy with CGM
Participants in the control arm will continue their standard insulin therapy. They will also receive a Freestyle Libre 3 glucose sensor (Abbott, USA).
干预措施: Standard insulin therapy with CGM (Device)
结局指标
主要结局
Cortical renal tissue oxygenation (R2*)
时间窗: at 26 weeks
Measured using BOLD-MRI
次要结局
- Glycated hemoglobin(at 26 weeks)
- Serum urea (umol/l)(at 26 weeks)
- R2* slope(at 26 weeks)
- Serum creatinine (umol/l)(at 26 weeks)
- Urine albumin/creatinine ratio (ACR)(at 26 weeks)
- Proportion of time spent above target glucose (>10.0mmol/l)(over 26 weeks)
- Proportion of time spent above target glucose (>20.0mmol/l)(over 26 weeks)
- Per-kidney renal perfusion (ml/min)(at 26 weeks)
- Kidney inflammation (T1, msec)(at 26 weeks)
- Medullary renal tissue oxygenation (R2*)(at 26 weeks)
- Mean sensor glucose(over 26 weeks)
- Non-inferiority for time spent below target glucose (<3.9mmol/L)(over 26 weeks)
- Standard deviation of sensor glucose(over 26 weeks)
- Coefficient of variation of sensor glucose(over 26 weeks)
- Proportion of time spent below target glucose (<3.5mmol/L)(over 26 weeks)
- Proportion of time spent below target glucose (<3.0mmol/L)(over 26 weeks)
- Proportion of time spent above target glucose (>13.9mmol/l)(over 26 weeks)
- Proportion of time spent above target glucose (>16.7mmol/l)(over 26 weeks)
- Proportion of time spent in the target glucose range (3.9 to 10.0mmol/l)(over 26 weeks)
研究者
Heba Al-Alwan
Medical doctor
Centre Hospitalier Universitaire Vaudois