IRB #

STUDY00023343

Title

A crossover study to assess the efficacy of a Robust AP closed loop system vs MPC closed loop system

Principal Investigator

Jessica Castle

Study Purpose

The purpose of this study is to test how well a new insulin glucose control system manages your blood sugar when you forget meal boluses. We are trying to determine if we can improve the amount of time that your blood sugar is in the target range. You will come to the clinic for two ~9 hour studies that will begin at 7am. You will eat two meals during the day without inputting any meal boluses in order to test the systems’ ability to adjust your insulin accordingly. We will monitor your glucose and ketones every 30 minutes for safety. A study coordinator will be present during the visits with the study investigator on call.

Medical Condition(s)

Type 1 diabetes

Eligibility Criteria

Inclusion Criteria:
-type 1 diabetic age 18-65 using an insulin pump
-A1c less than 10.5

Exclusion Criteria:
-Pregnancy
-Cardiovascular disease
-Renal or adrenal insufficiency
-Liver disease
-Anemia
-Hypoglycemia unawareness
-Bleeding disorder
-Use of immunosuppressive medication.
-Gastroparesis

Healthy Volunteers Needed

No

Placebo Chance

NA

Duration of Participation

8 weeks

Minors Included

No

Contact

Deborah Branigan
branigad@ohsu.edu

Sponsor

This study is funded by NIH.

Recruitment End

12/31/2021

Compensation Provided

Yes

Compensation

You will receive $340 for completion of all study visits. If you withdraw early from the study, compensation will be given as follows: $40 for the run-in visit and $150 for each of the 2 study visits. There is no compensation for the screening visit. If you are asked to repeat one of the four 9 hour studies due to technical problems, you will receive an additional $150.


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