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Closed Loop System

Artificial Pancreas Systems for Type 1 Diabetes

N/A
Recruiting
Led By Leah Wilson, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current use of a t:slim X2 insulin pump with Dexcom G6 with the use of Control IQ for at least 12 weeks
Diagnosis of type 1 diabetes mellitus for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entire 7 day study
Awards & highlights

Study Summary

This trial tests an algorithm for an artificial pancreas to detect missed meals and better control glucose levels for people at risk.

Who is the study for?
Adults over 18 with Type 1 Diabetes, living within 40 miles of the study site, who have been using a t:slim X2 insulin pump and Dexcom G6 CGM with Control IQ for at least 12 weeks. They must not be pregnant or planning pregnancy without proper contraception, have an HbA1c between ≥7.5% and ≤10%, no severe liver disease, infections, seizure disorders, recent drug trials participation, bleeding issues or allergies to Fiasp insulin.Check my eligibility
What is being tested?
The trial is testing a new missed meal bolus detection algorithm in an artificial pancreas system against usual care involving the t:slim X2 pump with Control IQ technology. The goal is to see if this new feature can better manage glucose levels in high-risk patients by automatically delivering insulin when meals are detected but not reported by users.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with insulin therapy such as low blood sugar (hypoglycemia), skin reactions at the infusion site, and possible allergic reactions to Fiasp insulin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been using a t:slim X2 insulin pump with Dexcom G6 and Control IQ for at least 12 weeks.
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I have been diagnosed with type 1 diabetes for over a year.
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I am 18 years old or older.
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I use a smartphone and can be contacted by the study team.
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I use less than 139 units of insulin daily.
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I am willing to use Fiasp insulin during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entire 7 day study
This trial's timeline: 3 weeks for screening, Varies for treatment, and entire 7 day study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of time with sensed glucose between 70-180 mg/dl
Secondary outcome measures
Coefficient of variation of glucose
Mean amount of insulin delivered per day
Mean sensed glucose
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MPC ArmExperimental Treatment1 Intervention
Participants will use the MPC closed-loop system for 7 days using Fiasp insulin. The first 6 hours will be spent in clinic being trained on the system, then eating a meal. Then the participant will take the system home to continue using for 7 days.
Group II: Control IQ armActive Control1 Intervention
Participants will continue their normal diabetes regimen which includes the t:slim X2 pump with Dexcom G6 CGM and Control IQ for 7 days. Participants will share their pump download and Dexcom Clarity data with study staff after the 7 days is complete.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
967 Previous Clinical Trials
6,845,646 Total Patients Enrolled
University of WashingtonOTHER
1,732 Previous Clinical Trials
1,842,084 Total Patients Enrolled
MultiCare Rockwood Northpointe Specialty CenterUNKNOWN

Media Library

MPC closed-loop system (Closed Loop System) Clinical Trial Eligibility Overview. Trial Name: NCT05799781 — N/A
Type 1 Diabetes Research Study Groups: MPC Arm, Control IQ arm
Type 1 Diabetes Clinical Trial 2023: MPC closed-loop system Highlights & Side Effects. Trial Name: NCT05799781 — N/A
MPC closed-loop system (Closed Loop System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05799781 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for individuals to join this research endeavor?

"On clinicaltrials.gov, this trial is flagged as actively seeking applicants with the initial post dating back to March 13th 2023 and last revised on March 23rd of the same year."

Answered by AI

What is the cap on how many individuals can join this research program?

"Affirmative. Per the clinicaltrials.gov record, this medical trial is presently looking for volunteers. The study was initially published on March 13th 2023 and has since been updated on March 23rd 2023 to search for 30 individuals across 3 sites."

Answered by AI
~2 spots leftby Apr 2024