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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
NOT_YET_RECRUITING
Lausanne
CHUV
RECRUITING
Lausanne
Contact Information
Primary
Heba Al-Alwan, MD, PhD
heba.al-alwan@chuv.ch
+4179 556 27 98
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2027-05
Participants
Target number of participants: 76
Treatments
Experimental: Fully closed-loop insulin delivery (CamAPS HX)
The CamAPS HX closed-loop system will consist of :~* mylife Ypsopump insulin pump (Ypsomed, Switzerland)~* FreeStyle Libre 3 CGM (Abbott, USA)~* Cambridge model predictive control algorithm on a smartphone (CamAPS, UK)~* Cloud upload system to review CGM/insulin data
Active_comparator: Standard insulin therapy with CGM
Participants in the control arm will continue their standard insulin therapy. They will also receive a Freestyle Libre 3 glucose sensor (Abbott, USA).
Related Therapeutic Areas
Sponsors
Collaborators: Swiss National Science Foundation, Switzerland, Institute of Primary Health Care (BIHAM), Switzerland
Leads: Heba Al-Alwan

This content was sourced from clinicaltrials.gov

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