Type 1 DiabetesNCT05083559
Two Way Crossover Closed Loop Study R-AP vs MPC
A study testing MPC AP algorithm and Robust R-AP algorithm in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- MPC AP algorithm and Robust R-AP algorithm
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2021to 3 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- MPC AP algorithm, Robust R-AP algorithm
- Keywords
- glucose sensor, automated insulin delivery systems
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPC AP algorithmDevice
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.
Robust R-AP algorithmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MPC AP system | Experimental | Participants will use the MPC AP system for automated insulin delivery for a 9 hour study visit. Receives: 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. Receives: Device: Robust R-AP algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 hour period following the first meal
Secondary outcomes (8)
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 for the 4 hour period following the first meal.
Measured: 4 hour period following the first meal
Number of Carbohydrate Treatments
Assess the cumulative number of carbohydrate treatments (defined as 15 or 20 grams of carbohydrate) for the four hour period following the first meal.
Measured: 4 hour period following the first meal
Number of Provider-administered Insulin Injections
Assess the cumulative number of provider-administered insulin injections to treat hyperglycemia in the 4 hour period following the first meal.
Measured: 4 hour period following the first meal
Mean Sensed Glucose
Assess the mean sensed glucose from the Dexcom G6 reported sensor glucose values for the four hour period following the first meal.
Measured: 4 hour period following the first meal
Percent of Time With Sensed Glucose <54 mg/dl
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.
Measured: 4 hour period following the first meal
Percent of Time With Sensed Glucose >180 mg/dl
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.
Measured: 4 hour period following the first meal
Percent of Time With Sensed Glucose >250 mg/dl
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.
Measured: 4 hour period following the first meal
Mean Amount of Insulin Delivered Per Day (in Units)
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.
Measured: 4 hour period following the first meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start8 Dec 2021
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Castle, Oregon Health and Science University
- Investigators
- Peter Jacobs, PhD, Principal investigator, Oregon Health and Science UniversityJessica Castle, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083559
- Sponsor's protocol ID
- 23343
- Other IDs
- 5R01DK120367-04
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2021
- Last updated
- 20 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study to Assess the Efficacy of a Robust AP Closed Loop System vs MPC Closed Loop System
- ClinicalTrials.gov ID
- NCT05083559
- Acronym / sponsor ID
- 23343
- Conditions
- Type 1 Diabetes
- Keywords
- glucose sensor, automated insulin delivery systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Posted 20 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPC AP system | Experimental | Device: MPC AP algorithmParticipants will use the MPC AP system for automated insulin delivery for a 9 hour study visit. |
| Robust R-AP system | Experimental | Device: Robust R-AP algorithmParticipants will use the Robust R-AP system for automated insulin delivery for a 9 hour study visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPC AP algorithmThe 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. | Device | MPC AP system |
| Robust R-AP algorithmThe 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. | Device | Robust R-AP system |
Primary outcome
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.
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Time frame: 4 hour period following the first meal
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor for the four hour period following the first meal.
8 secondary outcomes
Percent of Time With Sensed Glucose <70 mg/dl
Time frame: 4 hour period following the first meal
Number of Carbohydrate Treatments
Time frame: 4 hour period following the first meal
Number of Provider-administered Insulin Injections
Time frame: 4 hour period following the first meal
Mean Sensed Glucose
Time frame: 4 hour period following the first meal
Percent of Time With Sensed Glucose <54 mg/dl
Time frame: 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
Percent of Time With Sensed Glucose >250 mg/dl
Time frame: 4 hour period following the first meal
Mean Amount of Insulin Delivered Per Day (in Units)
Time frame: 4 hour period following the first meal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Jacobs, PhD principal investigator
Oregon Health and Science University
Jessica Castle, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPC AP algorithm and Robust R-AP algorithm in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of Postprandial Glucose (time frame: 4 hour period following the first meal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023; AzTrials last refreshed its copy on 29 Oct 2026.