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RECRUITING

NCT06925217

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

Sponsor: Heba Al-Alwan

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-16

Completion Date

2027-05

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Type 2 Diabetes Chronic Kidney Disease Stage 3

Interventions

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

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

Locations (2)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

CHUV

Lausanne, Switzerland