Diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
Each study arm will involve the use of CE-marked Continuous Glucose Monitoring (CGM) systems. Adults with Type 1 or Type 2 diabetes will wear between one and three sensors for a period of up to 31 day
Sponsors
Abbott Diabetes Care Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years old. 2. Have type 1 or type 2 diabetes. 3. Is willing to provide a minimum of 4 and no more than 12 capillary fingerprick blood samples for each day of sensor wear. 4. Is able to read and understand English. 5. In the investigator’s opinion, the participant is willing to wear the sensor(s), to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. 6. Agrees to continue using their current method of glucose monitoring for duration of study.
Exclusion criteria
Exclusion criteria: 1. Has participated in the same study event. 2. Is a member of the study staff. 3. Is pregnant, planning to become pregnant within the study event duration, or becomes pregnant during the study. 4. Has known (or suspected) allergy to medical grade adhesive at enrolment. 5. Has a skin abnormality at the application sites. 6. Is currently participating in another clinical study that could affect their glucose management. 7. Has a known concomitant medical condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the participant or study staff. 8. Has a pacemaker or any other neurostimulators. 9. Is unsuitable for participation due to any other cause as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of system readings that are within ±20% for glucose levels =70 mg/dL and within ±20 mg/dL for glucose levels <70 mg/dL compared to capillary fingerstick blood glucose (BG) values, over the duration of sensor wear | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcomes (AEs/ DIs) will be recorded, over the duration of sensor wear | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactPamela Reid
Outcome results
None listed