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New treatment option for Type 2 Diabetes
Official title Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes
ClinicalTrials.gov ID: NCT06925217
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Known or suspected allergy against insulin
- Pregnancy, planned pregnancy, or breast feeding
See the full eligibility 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/1.73m² 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
- Lausanne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland; Lausanne, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.