Type 1 DiabetesNCT07914621
Outpatient Pramlintide Study
A study testing MPC closed-loop system in insulin only mode and MPC closed-loop system in Insulin/Pramlintide mode in people with Type 1 Diabetes, run by Oregon Health and Science University.
Trial summary
The primary purpose of this study is to evaluate performance of a non-hybrid, fully automated closed loop system that does not require the person to announce meals to the system, and will utilize the hormone analog pramlintide in combination with insulin to potentially reduce the meal related hyperglycemia and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- MPC closed-loop system in insulin only mode and MPC closed-loop system in Insulin/Pramlintide mode
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 31 Jan 2027
- 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 70 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.
- 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.
- Uses a carbohydrate ratio, at least occasionally, to dose meal-time insulin
- HbA1c ≤ 10.5% at screening.
- Total daily insulin requirement is less than 139 units/day.
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- 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.
- 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
- 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 site 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 included in Appendix A. Participants will be excluded for four or more R responses.
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- 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.
- 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.
- Allergy or intolerance of pramlintide.
- 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).
- Current use of beta blockers or non-dihydropyridine calcium channel blockers.
- Current use of any medication that may lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin, empaglifozin etc) including the use of GLP1RA medications for weight loss (ex. Wegovy or Zepbound).
- Gastroparesis or history of chronic nausea and/or frequent emesis.
- Low carbohydrate diet at the time of screening defined as less than 50 grams of carbohydrate per day.
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Outpatient Crossover Study to Evaluate Insulin and Pramlintide Versus Insulin Alone Delivery Strategy
The primary purpose of this study is to evaluate performance of a non-hybrid, fully automated closed loop system that does not require the person to announce meals to the system, and will utilize the hormone analog pramlintide in combination with insulin to potentially reduce the meal related hyperglycemia and increase the time spent in target range during the daytime.
- Conditions
- Type 1 Diabetes
- Being tested
- MPC closed-loop system in insulin only mode, MPC closed-loop system in Insulin/Pramlintide mode
- 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 closed-loop system in insulin only modeDevice
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.
MPC closed-loop system in Insulin/Pramlintide modeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Only Arm | Experimental | Participants will use the closed loop system with insulin only for managing blood sugar for 1 week. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Receives: 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 for 1 week. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Receives: Device: MPC closed-loop system in Insulin/Pramlintide mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time with sensed glucose between 70-180 mg/dl
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.
Measured: 12 hours following in-clinic visit
Secondary outcomes (17)
Incremental area under the curve of postprandial glucose
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 observation period. Values shown are iAUC/1000.
Measured: 6 hours following the start of standarized in-clinic meal
Percent of time with sensed glucose <70 mg/dl
Measured: 12 hours following in-clinic visits
Percent of time with sensed glucose between 70 - 140 mg/dl
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.
Measured: 12 hours following in-clinic visits
Mean Sensed glucose
Measured: 12 hours following in-clinic visits
Coefficient of variation of glucose
Measured: 12 hours following in-clinic visits
Percent of time with sensed glucose <54 mg/dl
Measured: 12 hours following in-clinic visits
Percent of time with sensed glucose >180 mg/dl
Measured: 12 hours following in-clinic visits
Percent of time with sensed glucose >250 mg/dl
Measured: 12 hours following in-clinic visits
Mean amount of insulin delivered (in units and units/kg)
Measured: 12 hours following in-clinic visits
Mean amount of pramlintide delivered (in mcg and mcg/kg)
Measured: 12 hours following in-clinic visits
Percent of time with sensed glucose between 70-180 mg/dl
Measured: 12 hours following first meal in-clinic
Number of adverse events probably or possibly associated with Pramlintide administration
Measured: After the completion of study, an average of 2 weeks
Baxter Retching Faces VAS scale for standardized in-clinic meal
Measured: After the completion of study, an average of 2 weeks
Mean duration of gastrointestinal issues after standardized in-clinic meal as reported by participant on BARF VAS scale
Measured: After the completion of study, an average of 2 weeks
Episodes of carbohydrate intake to treat hypoglycemia
Measured: After the completion of study, an average of 2 weeks
Mean number of low glucose events / day whereby a single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements
Measured: After the completion of study, an average of 2 weeks
Mean amount of insulin delivered (in units and units/kg)
Measured: 12 hours following first meal in-clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Lester, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914621
- Sponsor's protocol ID
- STUDY00029226
- Other IDs
- 1R01DK129382-01
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outpatient Crossover Study to Evaluate Insulin and Pramlintide Versus Insulin Alone Delivery Strategy
- ClinicalTrials.gov ID
- NCT07914621
- Acronym / sponsor ID
- STUDY00029226
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 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
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
The primary purpose of this study is to evaluate performance of a non-hybrid, fully automated closed loop system that does not require the person to announce meals to the system, and will utilize the hormone analog pramlintide in combination with insulin to potentially reduce the meal related hyperglycemia and increase the time spent in target range during the daytime.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Only Arm | Experimental | Device: MPC closed-loop system in insulin only modeParticipants will use the closed loop system with insulin only for managing blood sugar for 1 week. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. |
| Insulin and Pramlintide Arm | Experimental | Device: MPC closed-loop system in Insulin/Pramlintide modeParticipants will use the closed loop system with insulin and pramlintide for managing blood sugar for 1 week. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Uses a carbohydrate ratio, at least occasionally, to dose meal-time insulin
- HbA1c ≤ 10.5% at screening.
Key exclusion criteria (26 listed)
- 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 site 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.
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 closed-loop system in insulin only modeThe 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. | Device | Insulin Only Arm |
| MPC closed-loop system in Insulin/Pramlintide modeThe 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. | Device | Insulin and Pramlintide Arm |
Primary outcome
Percent of time with sensed glucose between 70-180 mg/dl
Time frame: 12 hours following in-clinic visit
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.
17 secondary outcomes
Incremental area under the curve of postprandial glucose
Time frame: 6 hours following the start of standarized in-clinic meal
Percent of time with sensed glucose <70 mg/dl
Time frame: 12 hours following in-clinic visits
Percent of time with sensed glucose between 70 - 140 mg/dl
Time frame: 12 hours following in-clinic visits
Mean Sensed glucose
Time frame: 12 hours following in-clinic visits
Coefficient of variation of glucose
Time frame: 12 hours following in-clinic visits
Percent of time with sensed glucose <54 mg/dl
Time frame: 12 hours following in-clinic visits
Percent of time with sensed glucose >180 mg/dl
Time frame: 12 hours following in-clinic visits
Percent of time with sensed glucose >250 mg/dl
Time frame: 12 hours following in-clinic visits
Mean amount of insulin delivered (in units and units/kg)
Time frame: 12 hours following in-clinic visits
Mean amount of pramlintide delivered (in mcg and mcg/kg)
Time frame: 12 hours following in-clinic visits
Percent of time with sensed glucose between 70-180 mg/dl
Time frame: 12 hours following first meal in-clinic
Number of adverse events probably or possibly associated with Pramlintide administration
Time frame: After the completion of study, an average of 2 weeks
Baxter Retching Faces VAS scale for standardized in-clinic meal
Time frame: After the completion of study, an average of 2 weeks
Mean duration of gastrointestinal issues after standardized in-clinic meal as reported by participant on BARF VAS scale
Time frame: After the completion of study, an average of 2 weeks
Episodes of carbohydrate intake to treat hypoglycemia
Time frame: After the completion of study, an average of 2 weeks
Mean number of low glucose events / day whereby a single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements
Time frame: After the completion of study, an average of 2 weeks
Mean amount of insulin delivered (in units and units/kg)
Time frame: 12 hours following first meal in-clinic
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 3 Nov 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MPC closed-loop system in insulin only mode and MPC closed-loop system in Insulin/Pramlintide mode in people with Type 1 Diabetes, run by Oregon Health and Science University.
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 10 inclusion and 26 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Peter Jacobs, PhD (503-418-9331, jacobsp@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 sensed glucose between 70-180 mg/dl (time frame: 12 hours following in-clinic visit). 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 3 Nov 2026.