Type 1 DiabetesNCT06676657
Closed Loop Context Aware AID
A study testing iPancreas automated insulin delivery system 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 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- iPancreas automated insulin delivery system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 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 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.
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- 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.
Who cannot join
- 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.
- 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 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.
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- 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.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Bleeding disorder or platelet count below 50,000.
- Allergy to Fiasp 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).
- Use of beta blockers or non-dihydropyridine calcium channel blockers.
- Current use of any medication that can lower glucose other than insulin (ex. Wegovy, Jardiance) with the exception of metformin if dose has been stable for ≥3 months and patient willing to not change dose during study.
- Gastroparesis
- Diet consisting of less than 50 grams of carbohydrates per day.
- A positive response to any of the questions from the Physical Activity Readiness Questionnaire with one exception: participant will not be excluded if he/she takes a single blood pressure medication that doesn't impact heart rate and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).
- Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Leah Wilson, MD, 503-494-3273, wilsolea@ohsu.edu
Deborah Branigan, 503-418-9070, branigad@ohsu.edu
About this study
Official title: Assessment of a Fully-closed Loop AID System With a Context-aware Hyperglycemia Pattern Detection and Dosing Algorithm in People With Type 1 Diabetes
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.
Read the detailed description
Participants will be on study for approximately 4 weeks. During the study, participants will wear an Omnipod to deliver insulin. Participants will also wear a Dexcom G6 CGM. The CGM system will send sensed glucose data every 5 minutes wirelessly via Bluetooth Low Energy (BTLE) to an Android smartphone running the iPancreas app. The closed-loop system will receive activity data through an activity watch worn by the participant. Participants will complete system training on Day 1 in clinic and then spend the rest of the 4 weeks under free-living conditions. The first 3 weeks of the study will be the training period when the system will collect patterns from the glucose sensor, insulin, and fitness data that lead to high blood sugar. After the 3-week training period, participants will complete a virtual visit to train the participant on the high blood sugar detection and dosing algorithm, then continue to use for an additional week. Participants will complete meal and exercise challenges.
- Conditions
- Type 1 Diabetes
- Being tested
- iPancreas automated insulin delivery system
- Keywords
- automated insulin delivery systems, glucose sensor
- 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.
iPancreas automated insulin delivery systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iPancreas automated insulin delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: entire 4 week study
Secondary outcomes (6)
Percent of time with sensor glucose 70 to 180 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl comparing first 3 weeks vs. last week
Measured: entire 4 week study
Percent of time with sensor glucose 70 to 140 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-140 mg/dl comparing first 3 weeks vs. last week
Measured: entire 4 week study
Percent of time with sensor glucose greater than 180 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values more than 180 mg/dl
Measured: entire 4 week study
Coefficient of variation of glucose
Assess the coefficient of variation of sensor glucose reported from the Dexcom G6 CGM comparing first 3 weeks vs. last week
Measured: entire 4 week study
Insulin delivered
Assess the insulin delivered in units/kg/day comparing first 3 weeks vs. last week
Measured: entire 4 week study
Hypoglycemia treatments
Assess the number of hypoglycemia treatments (counted as 15 grams of oral carbohydrate) per day comparing first 3 weeks vs. last week
Measured: entire 4 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start22 Nov 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leah Wilson, Oregon Health and Science University
- Investigators
- Leah Wilson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676657
- Sponsor's protocol ID
- 26005
- Other IDs
- R01DK122583-01
- Status last verified
- Apr 2025
- First submitted
- 4 Nov 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Fully-closed Loop AID System With a Context-aware Hyperglycemia Pattern Detection and Dosing Algorithm in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06676657
- Acronym / sponsor ID
- 26005
- Conditions
- Type 1 Diabetes
- Keywords
- automated insulin delivery systems, glucose sensor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
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 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.
Detailed description
Participants will be on study for approximately 4 weeks. During the study, participants will wear an Omnipod to deliver insulin. Participants will also wear a Dexcom G6 CGM. The CGM system will send sensed glucose data every 5 minutes wirelessly via Bluetooth Low Energy (BTLE) to an Android smartphone running the iPancreas app. The closed-loop system will receive activity data through an activity watch worn by the participant. Participants will complete system training on Day 1 in clinic and then spend the rest of the 4 weeks under free-living conditions. The first 3 weeks of the study will be the training period when the system will collect patterns from the glucose sensor, insulin, and fitness data that lead to high blood sugar. After the 3-week training period, participants will complete a virtual visit to train the participant on the high blood sugar detection and dosing algorithm, then continue to use for an additional week. Participants will complete meal and exercise challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iPancreas automated insulin delivery system | Experimental | Device: iPancreas automated insulin delivery systemParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
- 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 MDRD equation as reported by the OHSU laboratory).
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 |
|---|---|---|
| iPancreas automated insulin delivery systemThe 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. | Device | iPancreas automated insulin delivery system |
Primary outcome
Percent of time with sensor glucose less than 70 mg/dl
Time frame: entire 4 week study
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
Percent of time with sensor glucose less than 54 mg/dl
Time frame: entire 4 week study
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
Percent of time the pattern evaluation windows occurred
Time frame: entire 4 week study
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
Percent of time with sensor glucose greater than 250 mg/dl
Time frame: entire 4 week study
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
6 secondary outcomes
Percent of time with sensor glucose 70 to 180 mg/dl
Time frame: entire 4 week study
Percent of time with sensor glucose 70 to 140 mg/dl
Time frame: entire 4 week study
Percent of time with sensor glucose greater than 180 mg/dl
Time frame: entire 4 week study
Coefficient of variation of glucose
Time frame: entire 4 week study
Insulin delivered
Time frame: entire 4 week study
Hypoglycemia treatments
Time frame: entire 4 week study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Leah Wilson, 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 iPancreas automated insulin delivery system 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 12 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leah Wilson, MD (503-494-3273, wilsolea@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of time with sensor glucose less than 70 mg/dl (time frame: entire 4 week study). The study lists 4 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 11 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.