The effectiveness of insulin administration with an insulin pump using a fully closed-loop system on renal oxygenation in people with type 2 diabetes suffering from moderate chronic kidney disease

Switzerland (ICTRP)

ICTRP Studien-ID
NCT06925217 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
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 (CLICK study) (BASEC)

Wissenschaftlicher Titel
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 (ICTRP)

Öffentlicher Titel
Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes (ICTRP)

Untersuchte Krankheit(en)
Type 2 DiabetesChronic Kidney Disease Stage 3 (ICTRP)

Untersuchte Intervention
Device: CamAPS HXDevice: Standard insulin therapy with CGM (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Ein-/Ausschlusskriterien
Inclusion Criteria:

- 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

- CKD defined either as an eGFR 30-59 ml/min/1.73m or presence of albuminuria > 3
mg/mmol (stage A2 or A3 according to KDIGO) with an eGFR > 30 ml/min/1.73m. CKD
must be present for at least 6 months.

- HbA1c < 12% based on a 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 Criteria:

- 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 or more 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

- History of renal transplantation requiring ongoing immunosuppressive therapy

- 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 (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Cortical renal tissue oxygenation (R2*) (ICTRP)

Proportion of time spent in the target glucose range (3.9 to 10.0mmol/l);Glycated hemoglobin;Proportion of time spent above target glucose (>10.0mmol/l);Mean sensor glucose;Non-inferiority for time spent below target glucose (<3.9mmol/L);Standard deviation of sensor glucose;Coefficient of variation of sensor glucose;Proportion of time spent below target glucose (<3.5mmol/L);Proportion of time spent below target glucose (<3.0mmol/L);Proportion of time spent above target glucose (>13.9mmol/l);Proportion of time spent above target glucose (>16.7mmol/l);Proportion of time spent above target glucose (>20.0mmol/l);Per-kidney renal perfusion (ml/min);Kidney inflammation (T1, msec);Medullary renal tissue oxygenation (R2*);R2* slope;Serum creatinine (umol/l);Serum urea (umol/l);Urine albumin/creatinine ratio (ACR) (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
Swiss National Science Foundation, Switzerland;Institute of Primary Health Care (BIHAM), Switzerland (ICTRP)

Weitere Kontakte
Heba Al-Alwan, MD, PhDHeba Al-Alwan, MD, PhD, heba.al-alwan@chuv.chheba.al-alwan@chuv.ch, +4179 556 27 98+4179 556 27 98 (ICTRP)

Sekundäre IDs
CLICK (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06925217 (ICTRP)