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Not yet recruitingNCT07914621Updated Nov 3, 2026

Outpatient Pramlintide Study

An interventional study of MPC closed-loop system in insulin only mode and MPC closed-loop system in Insulin/Pramlintide mode in Type 1 Diabetes, sponsored by Oregon Health and Science University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Health services research

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 increase the time spent in target range during the daytime.

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,619 studies on the registry are indexed under Diabetes Mellitus, Type 1; 587 are open to participants now.

This study's planned enrollment of 26 is below the median of 40 across 2,721 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.

Browse Oregon Health and Science University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Insulin Only Arm

    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.

    Device: MPC closed-loop system in insulin only mode

  • Experimental
    Insulin and Pramlintide Arm

    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.

    Device: MPC closed-loop system in Insulin/Pramlintide mode

Interventions

  • DeviceMPC closed-loop system in insulin only mode

    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.

  • DeviceMPC closed-loop system in Insulin/Pramlintide mode

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 hours following in-clinic visit

Secondary outcomes

  1. 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.

    Time frame: 6 hours following the start of standarized in-clinic meal

  2. Percent of time with sensed glucose <70 mg/dl

    Time frame: 12 hours following in-clinic visits

  3. 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.

    Time frame: 12 hours following in-clinic visits

  4. Mean Sensed glucose

    Time frame: 12 hours following in-clinic visits

  5. Coefficient of variation of glucose

    Time frame: 12 hours following in-clinic visits

  6. Percent of time with sensed glucose <54 mg/dl

    Time frame: 12 hours following in-clinic visits

  7. Percent of time with sensed glucose >180 mg/dl

    Time frame: 12 hours following in-clinic visits

  8. Percent of time with sensed glucose >250 mg/dl

    Time frame: 12 hours following in-clinic visits

  9. Mean amount of insulin delivered (in units and units/kg)

    Time frame: 12 hours following in-clinic visits

  10. Mean amount of pramlintide delivered (in mcg and mcg/kg)

    Time frame: 12 hours following in-clinic visits

  11. Percent of time with sensed glucose between 70-180 mg/dl

    Time frame: 12 hours following first meal in-clinic

  12. Number of adverse events probably or possibly associated with Pramlintide administration

    Time frame: After the completion of study, an average of 2 weeks

  13. Baxter Retching Faces VAS scale for standardized in-clinic meal

    Time frame: After the completion of study, an average of 2 weeks

  14. 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

  15. Episodes of carbohydrate intake to treat hypoglycemia

    Time frame: After the completion of study, an average of 2 weeks

  16. 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

  17. Mean amount of insulin delivered (in units and units/kg)

    Time frame: 12 hours following first meal in-clinic

Other outcomes

  1. Mean amount of pramlintide delivered (in mcg and mcg/kg)

    Time frame: 12 hours following first meal in-clinic

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.

Of 822 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 2 months is below that.

Counting every sponsor, half of 922 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Nov 3, 2026
StartEst.
Nov 2, 2026
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07914621
Lead sponsor
Oregon Health and Science University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Linda Lester (Associate Professor, Oregon Health and Science University) — Principal investigator
First posted
Nov 3, 2026
Start date
Nov 2, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Peter Jacobs, PhD
Contact
jacobsp@ohsu.edu
503-418-9331
Samrita Thapa, MPH
Contact
thapasa@ohsu.edu
503-494-8421

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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