The International Diabetes Closed Loop Trial DCLP4

Overview

About this study

The purpose of this study is to compare the effectiveness and safety of an automated insulin delivery (AID) study system using a Model Predictive Control (MPC) algorithm versus Sensor Augmented Pump (SAP) (which may or may not include PLGS; to be referred to as SAP) therapy in people with type 1 diabetes. A Pilot Phase involving up to 7 participants using the study system for 10-14 days will be conducted prior to the crossover 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:

  • Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
  • Using an insulin pump for at least 3 months (which may include use of automated features).
  • Familiarity and use of a carbohydrate ratio for meal boluses.
  • Age ≥ 18 years old.
  • 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 females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  • If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal CGM use during the study.
  • Willing not to begin use of, or not to continue use of if currently using, a personal AID (closed loop control) system during the study; note if the system offers an open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom G6, the system may be used during the study in these modes only.
  • Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
  • Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial, and not to use Afrezza during the trial.
  • Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol.

Exclusion Criteria:

  • Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial.
  • Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months.
  • Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months.
  • Hemophilia or any other bleeding disorder.
  • A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk.
  • History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment.
  • Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yogish Kudva, M.B.B.S.

Open for enrollment

Contact information:

Shelly McCrady-Spitzer M.S.

(507) 255-5916

McCradySpitzer.Shelly@mayo.edu

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-20503089

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