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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ entire 7 day study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entire 7 day study
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 30 days.I have had diabetic ketoacidosis in the last 6 months.I am not on long-term immunosuppressive medication.I have a significant heart condition or history of major heart issues.I have been using a t:slim X2 insulin pump with Dexcom G6 and Control IQ for at least 12 weeks.You have experienced severe low blood sugar in the past year, or have trouble recognizing when your blood sugar is low.I am not pregnant, planning to become pregnant, or breastfeeding, and I use effective birth control.I currently have an infection.I have a seizure disorder.I have a bleeding disorder, am on warfarin, or have low platelets.I am allergic to Fiasp insulin.I have been diagnosed with type 1 diabetes for over a year.I am 18 years old or older.Your HbA1c level is higher than 7.5% at the screening.I have severe leg pain due to poor blood flow even when at rest.I currently have an open sore on my foot.I use a smartphone and can be contacted by the study team.My kidney function is reduced.I have gastroparesis.I have been diagnosed with adrenal insufficiency.Your HbA1c level is higher than 10% at the screening.My liver is healthy and functions well.I am currently taking steroids in pill form or by injection.I use less than 139 units of insulin daily.I have not had any life-threatening diseases or cancer, except for skin cancer, in the last 5 years.You are currently eating a diet with less than 50 grams of carbohydrates per day.You have a history of using alcohol, drugs, or illegal substances in a harmful way.I am currently taking medication other than insulin to lower my blood sugar.I am currently taking beta blockers or certain types of blood pressure medicine.I am willing to use Fiasp insulin during the study.
Research Study Groups:
This trial has the following groups:- Group 1: MPC Arm
- Group 2: Control IQ arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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