Two Way Crossover Closed Loop Study MPC vs FMPD

NCT04771403 | Completed Results FDA Device

• 1 other identifier: 19973
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

An artificial pancreas (AP) is a control system for automatic insulin delivery. Our group has implemented a fading memory proportional derivative controller (FMPD) for use within an AP control system which has been evaluated in clinical studies. However, the long action of insulin (90 minutes for peak action) makes it challenging to control insulin with a classical proportional derivative system. The study described within this protocol is designed to test the effectiveness of a new model-predictive control (MPC) AP that modulates insulin delivery based on estimated activity level. The potential benefit of this type of AP is that it handles exercise not as a discrete event, but it automatically adjusts insulin delivery based on estimated activity level calculated at every 5 minute cycle. This type of algorithm may significantly improve glucose control over our FMPD AP, which is designed only to detect exercise when activity level goes above a threshold for a specific duration of 45 minutes.

Conditions

Type 1 Diabetes

Keywords

glucose sensor; automated insulin delivery systems

Outcome Measures

Primary Outcomes (1)

• Percent of Time With Sensed Glucose <70 mg/dl

  Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across the duration of the 12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD).

  12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD)

Secondary Outcomes (10)

• Percent of Time With Sensed Glucose Between 70-180 mg/dl

  During each 76 hour intervention study (2 total)

• Percent of Time With Sensed Glucose Between 70 - 180 mg/dl

  12 hour inpatient stay (either Day 3 or Day 1 MPC vs. Day 1 FMPD)

• Percent of Time With Sensed Glucose Between 70 - 180 mg/dl After Exercise

  start of the in-clinic exercise session until the start of the next meal, approximately 1 hour

• Percent of Time With Sensed Glucose <70 mg/dl After Exercise

  start of the in-clinic exercise session until the start of the next meal, approximately 1 hour

• Number of Carbohydrate Treatments

  During each 76 hour intervention study (2 total)

Study Arms (3)

FMPD AP system

EXPERIMENTAL

Participants will use the FMPD AP system for automated insulin delivery for a 76 hour study visit.

Device: FMPD AP algorithm

MPC AP System

EXPERIMENTAL

Participants will use the MPC AP system for automated insulin delivery for a 76 hour study visit.

Device: MPC AP system

Dexcom G6 Training Arm

EXPERIMENTAL

Participants will use the Dexcom G6 CGM system within the MPC AP system to generate sensor glucose data during a 7 day period.

Device: Dexcom G6 Continuous Glucose Monitoring (CGM) System

Interventions

FMPD AP algorithm DEVICE

The Fading Memory Proportional Derivative (FMPD) insulin infusion algorithm determines insulin delivery rates based on proportional error, defined as the difference between the current CGM level and the target CGM level, and the derivative error, defined as the rate of change of the CGM. The FMPD algorithm utilizes derivative and proportional glucose errors to determine delivery rates of insulin.

FMPD AP system

MPC AP system DEVICE

The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal inputs. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure. The metabolic expenditure then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM.

MPC AP System

Dexcom G6 Continuous Glucose Monitoring (CGM) System DEVICE

The Dexcom G6 CGM measures interstitial glucose through a sensor transmitter. This glucose value is reported to the MPC algorithm during this intervention.

Dexcom G6 Training Arm

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Male or female participants 21 to 50 years of age.
• Physically willing and able to perform aerobic exercise (as determined by the investigator after reviewing the participant's activity level)
• Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks.
• Lives with another person age 18 or older who will be present while participant exercises at home and that can attend the training on using the system.
• Lives within 40 miles of OHSU main campus.
• HbA1c ≤ 10% at screening.
• Total daily insulin requirement is less than 139 units/day.
• Current use of a phone or other device so can be contacted by study staff off-campus
• Willingness to follow all study procedures, including attending all clinic visits.
• Willingness to sign informed consent and HIPAA documents.

You may not qualify if:

• Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
• Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
• Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
• Hematocrit of less than 36% for men, less than 32% for women.
• Hypertensive participants with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite treatment or who have treatment-refractory hypertension (e.g. requiring four or more medications).
• History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
• History of diabetes ketoacidosis during the prior 6 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
• Adrenal insufficiency.
• Any active infection.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Seizure disorder.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Major surgical operation within 30 days prior to screening.
• Use of an investigational drug within 30 days prior to screening.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Juvenile Diabetes Research Foundation: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Jacobs PG, Resalat N, Hilts W, Young GM, Leitschuh J, Pinsonault J, El Youssef J, Branigan D, Gabo V, Eom J, Ramsey K, Dodier R, Mosquera-Lopez C, Wilson LM, Castle JR. Integrating metabolic expenditure information from wearable fitness sensors into an AI-augmented automated insulin delivery system: a randomised clinical trial. Lancet Digit Health. 2023 Sep;5(9):e607-e617. doi: 10.1016/S2589-7500(23)00112-7. Epub 2023 Aug 3.

  PMID: 37543512 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring; Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Jessica Castle
• Organization: Oregon Health and Science University

castleje@ohsu.edu

503-494-7072

Study Officials

• Peter Jacobs, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Jessica Castle, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 25, 2021
• Study Start: February 23, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)