E10
Conditions
Interventions
Group 1: Single-arm, monocentric study. After screening, all participants undergo placement of a continuous glucose monitoring system (CGM) followed by a hypoglycemic–hyperglycemic clamp procedure wit
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Participant must be 18 to 64 years of age, both inclusive, at the time of signing the informed consent. 2. Have been diagnosed with T1D and treated with continuous subcutaneous insulin infusion (CSII) for at least 12 months prior to screening. 3. Have a HbA1c value of =8.5% (=69 mmol/mol) at screening. 4. Have venous access sufficient to allow for blood sampling as per the protocol. 5. Have clinical laboratory test results within normal reference range for the population or results with acceptable deviations that are judged to be not clinically significant by the Investigator. 6. Have a body mass index (BMI) within the range 18.5 kg/m2 and 30.0 kg/m2 (both inclusive). 7. Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. 8. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing potential (WOCBP) who are pregnant, breast-feeding, or intend to become pregnant during the study, or who are not using adequate contraceptive methods. 2. Current enrolment or past participation in another investigational study in which an investigational intervention (e.g. drug, vaccine, invasive device) was administered within 30 days before signing informed consent for this study. 3. Significant acute or chronic illness that might interfere with participant safety or integrity of results as judged by the investigator. 4. Treated with any medication known to interfere with glucose metabolism, i.e. non-selective beta-blockers, systemic glucocorticoid therapy (excluding topical, intraarticular or inhaled preparations not reaching circulation), monoamine oxidase (MAO) inhibitors within 30 days or 5 half-lives (whichever is longer) before screening. Stable therapy with hormonal contraceptives (2 months) is allowed. 5. Treatment with thyroid hormones, unless stable use during the past 3 months before screening. 6. Smoke more than 10 cigarettes, or cigarette equivalent (as determined by Investigator), per day or are unable to abide by the study site’s tobacco and nicotine containing product restrictions. 7. Having a history of alcohol abuse within 1 year prior to screening, or positive alcohol breath test at screening. 8. History of drug abuse or positive result on urine drug test for drugs of abuse at screening. 9. Have had an episode of severe hypoglycaemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycaemia unawareness or poor recognition of hypoglycaemic symptoms. 10. Have had an episode of ketoacidosis or hyperosmolar state/coma requiring hospitalisation within the 6 months prior to screening. 11. Proliferative retinopathy or maculopathy and/or severe neuropathy (stage 3 and higher), in particular autonomic neuropathy (stage 2 – symptomatic autonomic neuropathy), as judged by the Investigator. 12. Have impaired renal estimated glomerular filtration rate <60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology. 13. Show evidence of possible chronic or active hepatitis B, including hepatitis B core antibody and/or hepatitis B surface antigen positivity (confirmed by PCR test, if serology test is positive). 14. Have a positive HCV antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV RNA test is negative. 15. Have evidence of HIV infection (positive HIV antibodies confirmed by PCR test). 16. Have a history of - acute myocardial infarction, - peripheral artery disease, - ischemic heart disease, - congestive heart failure, New York Heart Association class III or IV, - cerebrovascular accident (stroke [including transient ischemic attack]), - coronary artery revascularization, - hospitalization for unstable angina, and/or - hospitalization due to congestive heart failure. 17. Have a history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalaemia, family history of Long QT Syndrome). 18. Have a 12-lead ECG abnormality at screening that, in the opinion of the Investigator, increases the risks associated with participating in the study. 19. Have the following sustained measurements at screening for at least 3 months: systolic blood pressure of greater than 160 mm Hg, diastolic blood pressure of greater than 100
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of non-invasive glucose measurements using the DIROS technology across different glycaemic ranges in people with type 1 diabetes compared to venous plasma glucose as the gold standard, assessed during the hypoglycaemic–hyperglycaemic clamp procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Accuracy of non-invasive glucose measurements using the DIROS technology across different glycaemic ranges compared to a conventional continuous glucose monitoring (CGM) system. 2. Accuracy of non-invasive glucose measurements using the DIROS technology compared to reference values (venous plasma glucose and CGM) according to ISO 15197:2013. 3. Analysis of systematic measurement bias between glucose values obtained with the DIROS technology and reference measurements. 4. Safety of the DIROS technology, assessed by the frequency and type of adverse events (AE) and adverse device effects (ADE). | — |
Countries
Austria
Contacts
Public ContactThomas Pieber
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klinische Abteilung für Endokrinologie und Diabetologie
Outcome results
None listed