Actively Recruiting
Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes
Led by Heba Al-Alwan · Updated on 2026-02-12
76
Participants Needed
2
Research Sites
97 weeks
Total Duration
On this page
Sponsors
H
Heba Al-Alwan
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years and older
- Diagnosed with type 2 diabetes for at least 12 months
- Treated with insulin therapy for at least 6 months
- Chronic kidney disease stage 3 defined by eGFR 30-59 ml/min/1.73m² or albuminuria > 3 mg/mmol with eGFR > 30, present for at least 6 months
- HbA1c less than 12% based on screening blood test
- Receiving SGLT2 inhibitor and/or GLP-1 receptor agonist treatment for at least 3 months, or previously offered these treatments, or have contraindications/intolerance to them
- Willing to wear study devices and follow study instructions
- Able to provide informed consent
You will not qualify if you...
- Diagnosis of type 1 diabetes
- Current use of an insulin pump
- Current use of any closed-loop insulin delivery system
- Alternative causes of chronic kidney disease such as polycystic kidney disease, glomerulonephritis, congenital urogenital tract diseases
- Known or suspected allergy to insulin
- Pregnancy, planned pregnancy, or breastfeeding
- Severe visual or hearing impairment
- Two or more severe hypoglycemia episodes in the last 6 months
- Allergy to adhesive used on glucose sensors
- Serious skin diseases at sites for glucose sensor placement
- Physical or psychological conditions or medications interfering with study conduct or results as judged by the clinician
- Recent history (less than 3 months) of heart attack, stroke, coronary intervention, or hospitalization for heart failure
- History of kidney transplant requiring immunosuppressive therapy
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow study procedures due to language or other issues
- Unable to give informed consent
- Contraindications for MRI such as pacemaker, metallic devices, or severe claustrophobia
- Refusal to be informed of incidental health findings during the study
- Participation in another investigational study within 30 days before or during this study
- Previous enrollment in this study
- Enrollment of the principal investigator, family members, employees, or dependents in the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
Not Yet Recruiting
2
CHUV
Lausanne, Switzerland
Actively Recruiting
Research Team
H
Heba Al-Alwan, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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