A study to evaluate the performance of a continuous glucose monitoring device in people with diabetes

Not Applicable

Completed

• Conditions: Diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN89358739
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-18
• Study Completion: 2023-11-16
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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