Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

NCT06422325 | Completed Results FDA Device

• 1 other identifier: 25279
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 continuous glucose monitoring (CGM) and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.

Conditions

Type 1 Diabetes

Keywords

automated insulin delivery systems; glucose sensor; pramlintide

Outcome Measures

Primary Outcomes (2)

• Incremental Area Under the Curve of Postprandial Glucose Following the First Meal

  Incremental area under the curve (iAUC) of postprandial glucose (mg/dL\*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL\*min)/1000.

  6 hours following first meal

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

  Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

  6 hours following first meal

Secondary Outcomes (46)

• Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal

  6 hours following second meal

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

  6 hours following second meal

• Net Area Under the Curve of Postprandial Glucose Following the First Meal

  6 hours following first meal

• Net Area Under the Curve of Postprandial Glucose Following the Second Meal

  6 hours following second meal

• Net Area Under the Curve of Postprandial Glucose

  12 hour clinic visit

Study Arms (2)

Insulin Only Arm

EXPERIMENTAL

Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

Device: MPC closed-loop system in insulin only mode

Insulin and Pramlintide Arm

EXPERIMENTAL

Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

Device: MPC closed-loop system in insulin/pramlintide mode

Interventions

MPC closed-loop system in insulin only mode 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 device in this mode will administer insulin continuously for managing blood sugar.

Insulin Only Arm

MPC closed-loop system in insulin/pramlintide mode 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 device in this mode will administer both insulin and pramlintide continuously for managing blood sugar. The system will deliver pramlintide in a fixed ratio to insulin at 6 mcg of pramlintide delivered for every 1 unit of insulin.

Insulin and Pramlintide Arm

Eligibility Criteria

• Age: 18 Years - 70 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.
• Participants 18 to 70 years of age.
• Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks.
• Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin.
• 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:

• 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 3 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 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
• Adrenal insufficiency.
• Any active infection requiring treatment (example soft tissue infection requiring antibiotics).
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Seizure disorder.
• Active foot ulceration.
• 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).
• Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
• Allergy to aspart insulin.

Sponsors & Collaborators

• Oregon Health and Science University: lead

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: Leah Wilson
• Organization: Oregon Health & Science University

wilsolea@ohsu.edu

5034943273

Study Officials

• Leah Wilson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 15, 2024
• First Posted: May 20, 2024
• Study Start: July 12, 2024
• Primary Completion: January 4, 2025
• Study Completion: January 28, 2025
• Last Updated: March 5, 2026
• Results First Posted: March 5, 2026

Record last verified: 2026-02

Locations

US (1)