CompletedNot Applicable

Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

United States33 participantsStarted 2024-07-12

Plain-language summary

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 continuous glucose monitoring (CGM) and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks. * Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin. * 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: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested adding pramlintide to a closed-loop insulin system specifically to control blood sugar spikes after the first meal of the day — since I use or am considering a closed-loop system, is combining it with pramlintide something that might be worth discussing for my post-meal glucose control?
2The trial measured how much time glucose stayed between 70 and 180 mg/dl after the first meal, which is a standard 'time in range' target — based on how my own post-meal numbers look, would the kind of improvement this approach aimed for actually be meaningful for my situation?
3Since this study is completed but listed as Phase NA, meaning it may be a smaller or exploratory study rather than a large Phase 3 trial, how much weight should I give its findings when thinking about my own treatment options compared to more established evidence?
4Pramlintide is already FDA-approved for Type 1 diabetes but isn't commonly used — are there specific risks or side effects, like nausea or hypoglycemia, that become more of a concern when it's paired with a closed-loop system rather than used on its own?
5If the results from this crossover trial seem promising, are there larger or ongoing studies I should know about, or is standard closed-loop therapy alone still the better-supported path for someone in my position?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incremental Area Under the Curve of Postprandial Glucose Following the First Meal

Timeframe: 6 hours following first meal

Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal

Timeframe: 6 hours following first meal

Trial details

NCT IDNCT06422325

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-04

Results submitted2026-01-04

View on ClinicalTrials.gov More Type 1 Diabetes trials