Medical device study to evaluate the performance of a continuous glucose monitoring device by comparing device-generated data with capillary blood glucose comparison values in people with diabetes over a 14-day wearing period

F. Hoffmann-La Roche Ltd0 个研究点目标入组 48 人开始时间: 2023年9月18日最近更新: 2024年9月9日

适应症

试验速览

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39158986/ (added 29/08/2024)

•1. Diabetes mellitus type 1 or type 2 with insulin therapy diagnosed at least 12 months prior to screening
•2. Participants using automated insulin delivery (AID) systems: Willingness to stop its algorithm during the course of the Sampling Days (SDs)
•3. Acceptance to inject insulin or wearing an insulin pump infusion set minimum of 7.5 centimeter (cm) away from the CGM Sensor application site

•1. Potential participant older than 45 years with all three cardiovascular risks factors (smoker, arterial hypertension, glycated haemoglobin (HbA1c) >9.0%)
•2. Serious acute or chronic concomitant disease or an anamnesis which might, in the opinion of the investigator, pose a risk to the participant
•3. Severe diabetes related complications
•4. Significantly impaired awareness of hypoglycemia
•5. Severe hypoglycemia resulting in seizure or loss of consciousness in the three months prior to screening
•6. HbA1c >9.5% / 80.3 millimoles per mole (mmol/mol)
•7. Hematocrit greater than 10% below the lower limit of normal at screening
•8. History of adhesive incompatibility and/or allergy
•9. Skin alterations at the insertion sites (e.g., psoriasis vulgaris, scars, lipodystrophy)
•10. History of frequent catheter abscesses in the past year associated with insulin pump therapy, as per investigator’s discretion
•11. Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
•12. Anticoagulant treatment and platelet inhibition (with the exception of acetylsalicylic acid, daily dose rate <300 mg), phenprocoumon (e.g., marcumar), novel oral anticoagulants for atrial fibrillation (NOAK) (e.g., dabigatran, rivaroxaban)

发起方