Status:
RECRUITING
Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes
Lead Sponsor:
Heba Al-Alwan
Collaborating Sponsors:
Swiss National Science Foundation, Switzerland
Institute of Primary Health Care (BIHAM), Switzerland
Conditions:
Type 2 Diabetes
Chronic Kidney Disease Stage 3
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 stage 3 chronic kidney disea...
Detailed Description
Recruitment: The investigators aim to recruit 76 participants through the Service of Endocrinology, Diabetes, and Metabolism and through the Nephrology and Hypertension Service at the University Hosp...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Type 2 diabetes diagnosed for at least 12 months
- Treatment with insulin therapy for at least 6 months
- Stage 3 CKD (eGFR 30-59 ml/min/1.73m²) for at least 6 months
- HbA1c \< 12% based on 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
- 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 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
- Active cancer : primary tumour or metastatic
- Treatment with immunosuppressants within 3 months prior to screening
- 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
Key Trial Info
Start Date :
June 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06925217
Start Date
June 16 2025
End Date
May 1 2027
Last Update
July 11 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
2
CHUV
Lausanne, Switzerland