RECRUITINGINTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - willing to sign a consent form 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

CamAPS HX

The CamAPS HX fully closed-loop system consists of an insulin pump, a continuous glucose monitoring (CGM) sensor, as well as the CamAPS HX app, which resides on a smartphone and communicates wirelessly with the insulin pump.

DEVICE

Standard insulin therapy with CGM

Participants will continue their standard insulin therapy with a Freestyle Libre 3 CGM

Locations (2)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

CHUV

Lausanne, Switzerland