Automated glucose control's effect on kidney health in diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of fully automated closed-loop glucose control on renal tissue oxygenation in adults with type 2 diabetes and stage 3 chronic kidney disease. It is a single-center, open-label parallel design study comparing 26 weeks of closed-loop therapy to standard insulin therapy with continuous glucose monitoring. Participants will undergo a series of assessments including medical history, blood tests, and renal MRI to measure outcomes such as renal oxygenation and glycated hemoglobin levels. The study aims to recruit up to 76 adults through outpatient clinics in the Lausanne area.

Why it matters

Who can join: the full rules

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

Where it's running

• Chuv
  Lausanne, Switzerland Recruiting
• Centre Hospitalier Universitaire Vaudois
  Lausanne, Canton of Vaud, Switzerland Not yet recruiting

Study contacts

• Study coordinator: Heba Al-Alwan, MD, PhD
• Email: heba.al-alwan@chuv.ch
• Phone: +4179 556 27 98

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.