Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes

Summary

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.

Eligibility

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Conditions3

Browse More Trials