Two Way Crossover Closed Loop Study R-AP vs MPC

NCT05083559 | Completed Results FDA Device

• 2 other identifiers: 233435R01DK120367-04
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. The robust R-AP system used in this protocol has been designed to handle a variety of real-world scenarios that are critical to a high-risk patient population. The investigators will test how well the new algorithm handles missed or inaccurate meal announcements. This type of algorithm may significantly improve glucose control over the standard model predictive control (MPC) closed-loop algorithm without these new algorithm features for patients with type 1 diabetes.

Conditions

Type 1 Diabetes

Keywords

glucose sensor; automated insulin delivery systems

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve (AUC) of Postprandial Glucose

  Incremental AUC of postprandial glucose in the 4 hours following the start of first meal. AUC (mg/dL\*hr) will be calculated using a trapezoidal method, which sums all CGM values taken every 5 minutes in the 4 hour period following the meal above the starting glucose. This yields a maximum of 48 data points for the calculation.

  4 hour period following the first meal

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

  Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor for the four hour period following the first meal.

  4 hour period following the first meal

Secondary Outcomes (8)

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

  4 hour period following the first meal

• Number of Carbohydrate Treatments

  4 hour period following the first meal

• Number of Provider-administered Insulin Injections

  4 hour period following the first meal

• Mean Sensed Glucose

  4 hour period following the first meal

• Percent of Time With Sensed Glucose <54 mg/dl

  4 hour period following the first meal

Study Arms (2)

MPC AP system

EXPERIMENTAL

Participants will use the MPC AP system for automated insulin delivery for a 9 hour study visit.

Device: MPC AP algorithm

Robust R-AP system

EXPERIMENTAL

Participants will use the Robust R-AP system for automated insulin delivery for a 9 hour study visit.

Device: Robust R-AP algorithm

Interventions

MPC AP algorithm 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

Robust R-AP algorithm DEVICE

The R-AP is a modified MPC algorithm. A new feature in the algorithm includes a model for missed meal insulin detection. The model includes estimations for carbohydrate consumption based glucose patterns to determine if that person has consumed a meal without announcing it to the system.

Robust R-AP system

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Male or female participants 18 to 65 years of age.
• Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks.
• HbA1c ≤ 10.5% at screening.
• Total daily insulin requirement is less than 139 units/day.
• 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 intra-uterine device (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 Modification of Diet in Renal Disease (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.
• 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.
• Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

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

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: October 6, 2021
• First Posted: October 19, 2021
• Study Start: December 8, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: January 20, 2023
• Results First Posted: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)