Health TrialsbyHealthPanel

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

ConditionsType 2 DiabetesChronic Kidney Disease Stage 3
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeba Al-Alwan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CamAPS HX

    Device

    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.

  • Standard insulin therapy with CGM

    Device

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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Fully closed-loop insulin delivery (CamAPS HX)Experimental treatment 1 intervention
Group B: Standard insulin therapy with CGMActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cortical renal tissue oxygenation (R2*)

Measured using BOLD-MRI

Time frame
at 26 weeks

Secondary outcomes

1

Proportion of time spent in the target glucose range (3.9 to 10.0mmol/l)

Sensor glucose metric measured as a percentage

Time frame
over 26 weeks
2

Glycated hemoglobin

Time frame
at 26 weeks
3

Proportion of time spent above target glucose (>10.0mmol/l)

Sensor glucose metric measured as a percentage

Time frame
over 26 weeks
4

Mean sensor glucose

Sensor glucose metric measured in mmol/l

Time frame
over 26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heba Al-Alwan

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Sponsor institution

Swiss National Science Foundation

Collaborator

Institute of Primary Health Care (BIHAM), Switzerland

Collaborator

Source ClinicalTrials.gov
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