A Study of the Clinical Experience and Acceptance of the Artificial Pancreas

Overview

About this study

The purpose of this study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and then assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
  2. Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
  3. Age 14.0 to <75.0 years
  4. HbA1c level <10.5% at screening
  5. For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  6. Have care partner committed to participating in all training activities, knowledgeable at all times of the participants location, and being present and available to provide assistance when the system is being used at night
  7. Willingness, if using the closed-loop system, to stop closed-loop when taking acetaminophen and avoid closed-loop for at least 4 hours afterward
  8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
  9. Willingness to establish network connectivity on a daily basis either via local Wi-Fi network or via a study-provided cellular service
  10. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
  11. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra)

Exclusion Criteria

  1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
  2. More than one episode of severe hypoglycemia involving seizure of loss of consciousness in the 6 months prior to enrollment
  3. Medical need for chronic acetaminophen
  4. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
  5. Hemophilia or any other bleeding disorder
  6. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
  7. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  8. Employed by, or having immediate family members employed by TypeZero Technologies, LLC

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Yogish Kudva, M.B.B.S.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20304529

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