Diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will have three CGM sensors applied in both upper arms for continuous measurement of glucose levels in the subcutaneous interstitial fluid. CGM sensors will be paired with a CGM mobile ap
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Performance of the CGM sensor assessed as an agreement rate of >83% falling within ±20 milligrams per decilitre (mg/dL) (<100 mg/dL) and ±20% (=100 mg/dL) of paired capillary blood glucose values measured using SMBG measurements on multiple days up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Performance of the CGM sensor assessed as an agreement rate between paired CGM and SMBG values expressed as percentage falling within ±15/15, ±20/20, ±30/30, ±40/40 (mg/dL <100 mg/dL, % =100 mg/dL) for different glucose levels/ranges and for periods with stable and dynamic blood glucose levels measured using pairwise comparison on multiple days from Day 1 up to Day 14 2. Overall mean absolute relative difference (MARD) measured based on SMBG values across all CGM sensors, different glucose levels/ranges and for periods with stable and dynamic blood glucose levels from Day 1 up to Day 14 3. Availability of valid glucose values transmitted using CGM sensors measured from Day 1 up to Day 14 4. Consensus error grid (CEG) assessed based on the CGM sensor wear time up to Day 14 5. Comparison between the performance of two CGM sensors assessed as paired absolute relative difference (PARD) in one participant over 10 and 14 days 6. Classification of application pain measured using Numeric Pain Scale (NRS) on Day 1 7. Classification of bleeding after application measured on a scale of “no, mild, moderate, or severe” assessed on Day 1 8. Failure rate of investigational devices reported using device deficiency report from Day 1 up to Day 22 9. Number of adverse events (AEs), serious AEs (SAEs) adverse device effects (ADEs)/serious ADEs (SADEs) reported in accordance with Regulation (EU) 2017/745 on medical devices from Day 1 up to Day 22 10. Usability of the investigational device assessed using questionnaires for participants and the health care professionals (HCPs) on Day 1 and Day 15 | — |
Countries
Austria, Germany
Outcome results
None listed