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
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
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.
Recruitment:
The investigators aim to recruit 76 participants through the Service of Endocrinology, Diabetes, and Metabolism and through the Nephrology and Hypertension Service at the University Hospital of Lausanne (CHUV), as well as other outpatient diabetes clinics in the canton of Vaud if needed.
Screening visit:
Potential participants will have the opportunity to ask questions and will give written informed consent if interested in participating in the study. A screening blood test, a urine analysis, and urine pregnancy test will be done at this visit.
Baseline visit:
The baseline assessment will consist of a medical history, height and weight measurement, waist-hip ratio measurement and blood pressure measurement. Participants will also answer questionnaires to assess patient-reported outcome measures and undergo a renal MRI. A masked glucose sensor will be worn for 14 days.
Visit 3:
Randomisation will occur in a 1:1 ratio using REDCap to the use of fully closed-loop therapy or standard insulin therapy with continuous glucose monitoring (CGM) for 26 weeks once the participants complete the masked CGM period. Participants will attend the research center and receive training on study devices (closed-loop system or CGM) and study devices will be initiated.
Visit 4:
Participants will attend the research center around two days after initiation of the study arm to discuss potential issues related to use of study devices. This visit can also be conducted by phone.
Telephone contacts:
Participants in both arms will be contacted by telephone 1 week after initiation of the study arm, as well as at one, two, four, and five months after initiation of study arm to discuss any issues with devices, adverse events, or changes to medications.
Visit 5 (3 month visit):
Participants will attend the research center and fill-out questionnaires and a blood test and urine analysis will be performed.
Visit 6 (6 month visit):
Participants will attend the research center and fill-out questionnaires and a blood test and urine analysis will be performed. A renal MRI will be repeated at this visit. Study devices will be returned, and participants will resume their usual diabetes care.
Patient-reported outcomes:
Patient-reported outcome measures will be assessed using five validated questionnaires: Diabetes Distress Scale, Hypoglycemia Attitudes and Behavior Scale, Audit of Diabetes-Dependent Quality of Life, Diabetes Treatment Satisfaction Questionnaire - status version, Diabetes Treatment Satisfaction Questionnaire - change version
Safety outcomes:
Safety outcomes will include the number of severe hypoglycemia episodes, as well as the nature and severity of other adverse events including serious adverse events.
Inclusion Criteria:
Exclusion Criteria:
heba.al-alwan@chuv.ch+4179 556 27 98
heba.al-alwan@chuv.ch41795562798