Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes
Recruiting now · Not applicable
Conditions studied: Type 2 Diabetes, Chronic Kidney Disease Stage 3
In brief
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.
Key facts
- Study ID
- NCT06925217
- Run by
- Heba Al-Alwan
- People needed
- 76
- Starts
- 2025-06-16
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHUV — Lausanne, Switzerland (enrolling)
- Centre Hospitalier Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland
Full record on ClinicalTrials.gov
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