Artificial Pancreas With Different Stress Assessments in the Outpatient Setting

NCT04142229 | Completed FDA Device

• 1 other identifier: 19-006965
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; automated insulin delivery; artificial pancreas; stress

Outcome Measures

Primary Outcomes (1)

• Time in target glucose range

  Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system

  4 weeks

Secondary Outcomes (16)

• Change in glucose levels with stress induction

  4 weeks

• Change in insulin requirements with stress induction

  4 weeks

• EDA stress detection

  4 weeks

• Postprandial Time in Target Range

  4 weeks

• Glucose < 70 mg/dL

  4 weeks

Other Outcomes (7)

• Closed-Loop Active Time

  2 weeks

• Sensor Use Time

  4 weeks

• Device Issues

  4 weeks

Study Arms (2)

Automated Insulin Delivery

EXPERIMENTAL

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.

Device: iAPS

SAP/PLGS

ACTIVE COMPARATOR

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.

Other: Sensor-Augmented Pump

Interventions

iAPS DEVICE

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.

Automated Insulin Delivery

Sensor-Augmented Pump OTHER

Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor.

SAP/PLGS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Mayo Clinic: collaborator
• Harvard University: collaborator

Study Sites (2)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 32783473 RESULT

• 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.

  PMID: 35049354 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yogish Kudva, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Eyal Dassau, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Jordan Pinsker, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: October 25, 2019
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)