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Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes

NCT06925217 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-02-12

No results posted yet for this study

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 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

Interventions

DEVICE

CamAPS HX

The CamAPS HX fully closed-loop system consists of an insulin pump, a continuous glucose monitoring (CGM) sensor, as well as the CamAPS HX app, which resides on a smartphone and communicates wirelessly with the insulin pump.

DEVICE

Standard insulin therapy with CGM

Participants will continue their standard insulin therapy with a Freestyle Libre 3 CGM

Sponsors & Collaborators

  • Swiss National Science Foundation, Switzerland

    collaborator UNKNOWN

  • Institute of Primary Health Care (BIHAM), Switzerland

    collaborator UNKNOWN

  • Heba Al-Alwan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06925217 on ClinicalTrials.gov