Status:
NOT_YET_RECRUITING
Assessment of an Integrated Continuous Glucose Monitor and Insulin Injection Port in Type 2 Diabetes
Lead Sponsor:
Pacific Diabetes Technologies
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
THE GOALS of the STUDY are: (1) Determine if this novel continuous glucose monitoring (CGM) - multiple daily injection (MDI) port functions for 7 days in persons with Type 2 diabetes (T2D); (2) Measur...
Detailed Description
Study Goal: Carry out 7-day study in 18 subjects with T2D who use MDI. Compare use of the PDT CGM injection port with standard site-rotated MDI injections; test potential insulin incompatibility of lo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Type 2 diabetes with duration \> 6 months and age over 20;
- sufficient manual dexterity and visual acuity;
- willingness to wear two CGM devices and perform BG tests for 7 days.
- Exclusion criteria:
- untreated proliferative retinopathy;
- untreated mental illness that precludes study adherence
- untreated cardiovascular disorder such as unstable angina, severe heart failure,
- infectious diseases such untreated hepatitis, HIV, or active Covid-19;
- other severe body system disease.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05185518
Start Date
September 1 2025
End Date
February 1 2026
Last Update
January 11 2022
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