- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05083559
Two Way Crossover Closed Loop Study R-AP vs MPC
January 3, 2023 updated by: Jessica Castle, Oregon Health and Science University
A Crossover Study to Assess the Efficacy of a Robust AP Closed Loop System vs MPC Closed Loop System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will undergo two visits at Oregon Health and Science University (OHSU) that will evaluate missed meal bolus detection.
Participants will arrive at approximately 7am for all visits, be monitored through the afternoon and discharged before dinner.
During each of these intervention visits, participants will wear an Omnipod to deliver insulin and a Dexcom G6 Continuous Glucose Monitoring System (CGM) to measure glucose.
The closed loop system will receive activity data through a Polar M600 watch worn by the participant.
The studies will test the ability of the system to adapt to a missed meal bolus.
Participants will eat self selected meals at 10 am and 2pm, both meals with a missed bolus, and these meals will be repeated across both study arms.
For one missed meal bolus study, glucose will be controlled using the Robust R-AP closed-loop mode.
During the other missed meal bolus study, glucose will be controlled using the MPC closed-loop mode.
Participants will complete frequent glucose and ketone checks for safety.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- 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).
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- Allergy to aspart insulin.
- Current administration of oral or parenteral corticosteroids.
- Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- Beta blockers or non-dihydropyridine calcium channel blockers.
- Current use of any medication intended to lower glucose other than insulin (ex. use of liraglutide).
- Gastroparesis
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MPC AP system
Participants will use the MPC AP system for automated insulin delivery for a 9 hour study visit.
|
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.
|
Experimental: Robust R-AP system
Participants will use the Robust R-AP system for automated insulin delivery for a 9 hour study visit.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC) of Postprandial Glucose
Time Frame: 4 hour period following the first meal
|
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
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Percent of Time With Sensed Glucose Between 70-180 mg/dl
Time Frame: 4 hour period following the first meal
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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.
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4 hour period following the first meal
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Time With Sensed Glucose <70 mg/dl
Time Frame: 4 hour period following the first meal
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor for the 4 hour period following the first meal.
|
4 hour period following the first meal
|
Number of Carbohydrate Treatments
Time Frame: 4 hour period following the first meal
|
Assess the cumulative number of carbohydrate treatments (defined as 15 or 20 grams of carbohydrate) for the four hour period following the first meal.
|
4 hour period following the first meal
|
Number of Provider-administered Insulin Injections
Time Frame: 4 hour period following the first meal
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Assess the cumulative number of provider-administered insulin injections to treat hyperglycemia in the 4 hour period following the first meal.
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4 hour period following the first meal
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Mean Sensed Glucose
Time Frame: 4 hour period following the first meal
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Assess the mean sensed glucose from the Dexcom G6 reported sensor glucose values for the four hour period following the first meal.
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4 hour period following the first meal
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Percent of Time With Sensed Glucose <54 mg/dl
Time Frame: 4 hour period following the first meal
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Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor for the four hour period following the first meal.
|
4 hour period following the first meal
|
Percent of Time With Sensed Glucose >180 mg/dl
Time Frame: 4 hour period following the first meal
|
Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor for the four hour period following the first meal.
|
4 hour period following the first meal
|
Percent of Time With Sensed Glucose >250 mg/dl
Time Frame: 4 hour period following the first meal
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Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor for the four hour period following the first meal.
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4 hour period following the first meal
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Mean Amount of Insulin Delivered Per Day (in Units)
Time Frame: 4 hour period following the first meal
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Assess the mean amount of insulin delivered per day by the Omnipod through the AP system study in units for the four hour period following the first meal.
|
4 hour period following the first meal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 8, 2021
Primary Completion (Actual)
March 3, 2022
Study Completion (Actual)
March 3, 2022
Study Registration Dates
First Submitted
October 6, 2021
First Submitted That Met QC Criteria
October 6, 2021
First Posted (Actual)
October 19, 2021
Study Record Updates
Last Update Posted (Actual)
January 20, 2023
Last Update Submitted That Met QC Criteria
January 3, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23343 (Other Identifier: City of Hope Medical Center)
- 5R01DK120367-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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