Assessment of a Fully-closed Loop AID System With a Context-aware Hyperglycemia Pattern Detection and Dosing Algorithm in People With Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a high blood sugar detection and dosing algorithm for use within an AP control system. If a high blood sugar pattern is detected, correction insulin will be calculated and delivered. The investigators will test how well the new algorithm manages glucose compared to the AP control system without high blood sugar detection and dosing. This type of algorithm may improve glucose control for high risk patient populations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.

• Male or female participants 18 and older.

• HbA1c or GMI ≥ 7.0% at screening.

• Physically willing and able to perform 30 min of exercise (as determined by the investigator after reviewing the participant's activity level).

• Current use of an FDA-approved hybrid closed loop system for ≥3 months.

• Lives with another person age 18 or older who will sleep in the house at night and that can attend the training on using the system.

• Lives within 40 miles of OHSU

• Total daily insulin requirement is less than 139 units/day.

• Able to read, write and understand spoken English

• Current use of a smartphone so can be contacted by study staff off-campus.

• Willingness to follow all study procedures, including attending all clinic visits.

• Willingness to sign informed consent and HIPAA documents.

Locations
United States
Oregon
Oregon Health and Science University
RECRUITING
Portland
Contact Information
Primary
Leah Wilson, MD
wilsolea@ohsu.edu
503-494-3273
Backup
Deborah Branigan
branigad@ohsu.edu
5034189070
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 10
Treatments
Experimental: iPancreas automated insulin delivery system
Participants will use the iPancreas automated insulin delivery system for 4 weeks at home. After 3 weeks of collecting high blood sugar pattern data, the high blood sugar pattern detection and dosing feature will be turned on.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov