NCT06925217Toboroz
Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 12.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 76 (tervezett)
- Első benyújtás
- 2025. márc. 30.
- Kezdés
- 2025. jún. 16.
- Elsődleges befejezés
- 2027. máj.
- Fő szponzor
- Heba Al-Alwan
- Betegségek
- 2-es típusú cukorbetegség, Krónikus vesebetegség
- NCT-szám
- NCT06925217
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 76
- 2025. jún. 16. és az elsődleges befejezés (2027. máj.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Known or suspected non-compliance, drug or alcohol abuse
- 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
Más betegség
- Type 1 diabetes
- 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
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters
- 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
- History of renal transplantation requiring ongoing immunosuppressive therapy
Laborértékek
- Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- Recent (less than three months) history of myocardial infarction, percutaneous coronary intervention, stroke, or hospitalization for heart failure with reduced ejection fraction
Egyéb
- Current use of insulin pump
- Current use of any closed-loop system
- Pregnancy, planned pregnancy, or breast feeding
- Two or more episodes of severe hypoglycemia in the last 6 months
- 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
- Enrolment of the PI, his/her family members, employees and other dependent persons
Kiket keres a vizsgálat
- 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/1.73m² or presence of albuminuria > 3 mg/mmol (stage A2 or A3 according to KDIGO) with an eGFR > 30 ml/min/1.73m². 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHUV | Lausanne | Svájc | Toboroz |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Svájc | Toborzás még nem indult |
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