Artificial Pancreas With Different Stress Assessments in the Outpatient Setting
NCT ID: NCT04142229
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2019-10-25
2020-11-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Automated Insulin Delivery
Participants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting, and come to the clinical center twice for supervised stress assessments.
iAPS
The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.
SAP/PLGS
Participants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting, and come to the clinical center twice for supervised stress assessments.
Sensor-Augmented Pump
Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor.
Interventions
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iAPS
The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.
Sensor-Augmented Pump
Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Laboratory results:
* HbA1c \> 10.5%
* Abnormal liver or renal function (Transaminase \>2 times the upper limit of normal, creatinine\> 1.5 mg/dL)
* Labs drawn at screening visit or within three months prior to screening (for other purposes) will suffice for enrollment purposes
* Subject has skin conditions that, in the determination of the investigator, would preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.
* Currently on long-term treatment using prednisone or other steroid
* If subject had been on short term treatment of prednisone, defer enrollment until underlying condition and prednisone treatment have resolved.
* Allergy to study drug, food or other study material.
* Clinically significant physical examination, laboratory test, or vital sign abnormality.
* Exposure to any investigational drug within 30 days.
* History of malignancy within the 5 years before screening (other than basal cell carcinoma).
* Participation in another pharmaceutical or device trial at the time of enrollment or during the study
* Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Harvard University
OTHER
Sansum Diabetes Research Institute
OTHER
Responsible Party
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Principal Investigators
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Yogish Kudva, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Eyal Dassau, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard University
Jordan Pinsker, MD
Role: PRINCIPAL_INVESTIGATOR
Sansum Diabetes Research Institute
Locations
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Sansum Diabetes Research Institute
Santa Barbara, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Pinsker JE, Deshpande S, McCrady-Spitzer S, Church MM, Kaur RJ, Perez J, Desjardins D, Piper M, Reid C, Doyle FJ 3rd, Kudva YC, Dassau E. Use of the Interoperable Artificial Pancreas System for Type 1 Diabetes Management During Psychological Stress. J Diabetes Sci Technol. 2021 Jan;15(1):184-185. doi: 10.1177/1932296820948566. Epub 2020 Aug 12. No abstract available.
Kaur RJ, Deshpande S, Pinsker JE, Gilliam WP, McCrady-Spitzer S, Zaniletti I, Desjardins D, Church MM, Doyle Iii FJ, Kremers WK, Dassau E, Kudva YC. Outpatient Randomized Crossover Automated Insulin Delivery Versus Conventional Therapy with Induced Stress Challenges. Diabetes Technol Ther. 2022 May;24(5):338-349. doi: 10.1089/dia.2021.0436. Epub 2022 Apr 25.
Other Identifiers
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19-006965
Identifier Type: -
Identifier Source: org_study_id