Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT06782568
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and above
* Any type of diabetes of at least 1-year duration managed with multiple daily injections (MDI \[ie separate rapid-acting and basal insulin injections\]) or insulin pump therapy (CSII)
* Currently using any form of continuous glucose monitoring (CGM) with use \>70% in the last 4 weeks
* No anticipated changes to diabetes treatment in the next 6 months such as introduction of novel agents like GLP-1, SGLT2 or introduction (Tupe 2 diabetes) or AID (Type 1 diabetes)
* Coefficient of variation (CV) of CGM glucose \>36% and Time in the range between 3.9 to 10.0 mmol/l is \<70%
* The participant is willing and able to implement the study requirements and undergo two ultrasound scans of the insulin injection sites
* Participants is able understand English sufficiently for safe study conduct
Exclusion Criteria:
* Any other physical disease or people with known severe mental illness that are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Known to have any form of lipodystrophy disorder either primary or secondary to other medical conditions
* Dercum's disease
* Women who are pregnant or planning pregnancy
* The participant has an active major life-threatening illness limiting the participants life-expectancy to \<6 months
* Estimated Glomerular Filtration Rate (e-GFR) \< 25
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06782568
Study Brief:
Protocol Section:
NCT06782568