Clinical performance evaluation of three continuous glucose monitoring systems in adults with diabetes mellitus using a newly proposed testing procedure

Not Applicable

• Conditions: E14; Unspecified diabetes mellitus

• Registration Number: DRKS00033697
• Lead Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-26
• Study Completion: 2024-07-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Clinical diagnosis of type 1 or type 2 diabetes mellitus
2. Age = 18 years
3. Intensive insulin therapy established for at least six months
4. An understanding of and willingness to follow the protocol
5. Signed informed consent

Exclusion Criteria

1. HbA1c > 10%
2. Hypoglycemia unawareness
3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
4. Severe acute or severe chronic illness (at the physician’s discretion)
5. Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives
6. Skin alteration at the insertion sites (e.g., severe psoriasis vulgaris, severe scaring, severe lipodystrophia, severe rash)
7. Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy)
8. Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental or visual incapacity, language barriers, alcohol or drug misuse
9. Dependency from the sponsor or the clinical investigator
10. Intake of substances known to affect the performance of the investigational CGM systems, i.e., hydroxyurea, acetaminophen, and nutritional supplementation of ascorbic acid (vitamin C)
11. Planned medical procedures during the core study period that could affect the performance of the investigational CGM systems, including magnetic resonance imaging, computer tomography scan, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound
12. Infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immuno-deficiency virus (HIV) or other chronic infectious disease
13. Body mass index (BMI) <20 kg/m²
14. Intake of anticoagulants, except for acetylsalicylic acid in doses up to 100 mg

Study & Design

• Study Type: interventional
• Study Design: Not specified