Artificial Pancreas With Different Stress Assessments in the Outpatient Setting

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

This feasibility study is a randomized crossover trial that will compare the efficacy and safety of an automated insulin delivery (AID) system in patients with type 1 diabetes using a Model Predictive Control (MPC) algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS), and will include different stress induction and assessments over a 4 week period.

Key facts

Study ID

NCT04142229

Run by

Sansum Diabetes Research Institute

People needed

14

Starts

2019-10-25

Expected to finish

2020-11-06

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 at the time of screening. Insulin pump use includes use of automated features, to include predictive or threshold low-glucose suspend or hybrid closed-loop with or without a Dexcom sensor.
• Familiarity and use of a carbohydrate ratio for meal boluses.
• Age ≥18.0 years old
• HbA1c < 10.5%, as performed by point of care or central laboratory testing. HbA1c will be assessed at the screening visit, or if already completed within 2 weeks of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
• 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 and up to one month afterwards. 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.
• Willingness to switch home pump to PLGS or full manual mode if using hybrid - Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
• 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.

You may not qualify if…

• Use of an unapproved closed-loop insulin delivery system within 2 weeks before screening or during the study is not allowed.
• Have a blood pressure at screening outside the range of 160 mmHg systolic blood pressure and/or greater than 100 mmHg for diastolic blood pressure (if repeated measurements are within this range, the patient may be included in the study)
• Have coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
• Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• Hemophilia or any other bleeding disorder
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk, to include:
• Pregnancy, or planning pregnancy within 1 month of completing the clinical trial.
• Allergy or hypersensitivity to hydrocortisone, or any component of the formulation
• Presence of a known adrenal disorder
• Systemic fungal infections
• Active infection of any kind, or at risk of infection (susceptibility to infection) from known immunosuppression or underlying immunosuppressed condition
• Idiopathic thrombocytopenia purpura (ITP)
• Varicella
• Glaucoma or other chronic ocular condition that could be adversely affected by steroids (e.g., cataracts, increased ocular pressure from other causes, exophthalmos)
• Hypertension requiring treatment with one or more antihypertensive medications
• Congestive heart failure
• Current treatment for a seizure disorder
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write
• Known coronary artery disease
• Active gastroparesis
• Cystic fibrosis
• Uncontrolled thyroid disease (TSH undetectable or > 10 mIU/L)
• Known abuse of alcohol
• A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
• Current use of a beta blocker medication

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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