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Assessment of an Integrated Continuous Glucose Monitor and Insulin Injection Port in Type 2 Diabetes

NCT05185518 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-01-11

No results posted yet for this study

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) Measure the duration of glucose measurement errors that result from injecting liquid into the tissue. It is believed that these errors will be small and will not exceed 15-20 min in duration; (3) Determine how safe this device is; (4) In a survey given to subjects and other subjects after the study, to assess satisfaction and convenience vs standard MDI; (5) Assess accuracy of the glucose sensor; and (6) Compare how well subjects' glucose is controlled with the new device compared to the comparison (control) period in which subjects use standard MDI, during which the injections will be far away from the CGM.

Conditions

  • Type 2 Diabetes Treated With Insulin

Interventions

DEVICE

Use of novel insulin injection port

use subcutaneous port into which glucose monitor is embedded

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Pacific Diabetes Technologies

    lead INDUSTRY

Principal Investigators

  • William K. Ward, MD · Pacific Diabetes Technologies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-12-31
Completion
2026-02-28
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05185518 on ClinicalTrials.gov