Closed Loop Context Aware AID

NCT06676657 | Recruiting FDA Device

• 2 other identifiers: 26005R01DK122583-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a high blood sugar detection and dosing algorithm for use within an AP control system. If a high blood sugar pattern is detected, correction insulin will be calculated and delivered. The investigators will test how well the new algorithm manages glucose compared to the AP control system without high blood sugar detection and dosing. This type of algorithm may improve glucose control for high risk patient populations.

Conditions

Type 1 Diabetes

Keywords

automated insulin delivery systems; glucose sensor

Outcome Measures

Primary Outcomes (4)

• Percent of time with sensor glucose less than 70 mg/dl

  Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl comparing first 3 weeks vs. last week

  entire 4 week study

• Percent of time with sensor glucose less than 54 mg/dl

  Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl comparing first 3 weeks vs. last week

  entire 4 week study

• Percent of time the pattern evaluation windows occurred

  To assess the hyperglycemia pattern detection and dosing feature by evaluating the percent time that the feature is active in detecting hyperglycemic patterns during the pattern evaluation windows calculated as: (minutes in pattern evaluation window) / (total minutes) \* 100

  entire 4 week study

• Percent of time with sensor glucose greater than 250 mg/dl

  Assess the percent of time that the Dexcom G6 reported sensor glucose values more than 250 mg/dl comparing first 3 weeks vs. last week

  entire 4 week study

Secondary Outcomes (6)

• Percent of time with sensor glucose 70 to 180 mg/dl

  entire 4 week study

• Percent of time with sensor glucose 70 to 140 mg/dl

  entire 4 week study

• Percent of time with sensor glucose greater than 180 mg/dl

  entire 4 week study

• Coefficient of variation of glucose

  entire 4 week study

• Insulin delivered

  entire 4 week study

Study Arms (1)

iPancreas automated insulin delivery system

EXPERIMENTAL

Participants will use the iPancreas automated insulin delivery system for 4 weeks at home. After 3 weeks of collecting high blood sugar pattern data, the high blood sugar pattern detection and dosing feature will be turned on.

Device: iPancreas automated insulin delivery system

Interventions

iPancreas automated insulin delivery 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 in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs 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. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The MPC has a new feature called hyperglycemia pattern detection and dosing algorithm that will analyze problem patterns associated with high blood sugar and automatically calculate and deliver a correction dose.

iPancreas automated insulin delivery system

Eligibility Criteria

• Age: 18 Years - 100 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 and older.
• HbA1c or GMI ≥ 7.0% at screening.
• Physically willing and able to perform 30 min of exercise (as determined by the investigator after reviewing the participant's activity level).
• Current use of an FDA-approved hybrid closed loop system for ≥3 months.
• Lives with another person age 18 or older who will sleep in the house at night and that can attend the training on using the system.
• Lives within 40 miles of OHSU
• Total daily insulin requirement is less than 139 units/day.
• Able to read, write and understand spoken English
• Current use of a smartphone 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:

• GMI or A1c \<6.5% or \>10.5%
• Sensor glucose shows \< 2% of time above 250 mg/dl in last 30 days.
• Individual 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.
• History of severe hypoglycemia during the past 6 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 (example skin infection requiring antibiotics)
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Seizure disorder.
• Active foot ulceration.
• Peripheral arterial disease.
• 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
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

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

• Leah Wilson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Wilson, MD

CONTACT

503-494-3273; wilsolea@ohsu.edu

Deborah Branigan

CONTACT

5034189070; branigad@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: November 22, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

US (1)