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Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide - Trial NCT06422325

Access comprehensive clinical trial information for NCT06422325 through Pure Global AI's free database. This phase not specified trial is sponsored by Oregon Health and Science University and is currently Not yet recruiting. The study focuses on Type 1 Diabetes. Target enrollment is 35 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.gov โ€ข NCT06422325
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Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide
A Crossover Study to Evaluate Insulin/Pramlintide Versus Insulin Alone Delivery Strategy

Study Focus

Type 1 Diabetes

MPC closed-loop system in insulin only mode

Interventional

device

Sponsor & Location

Oregon Health and Science University

Timeline & Enrollment

N/A

Jun 01, 2024

Dec 30, 2024

35 participants

Primary Outcome

Incremental area under the curve of postprandial glucose following the first meal,Percent of time with sensed glucose between 70 - 180 mg/dl following first meal

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 CGM and automatically send commands to one Omnipod for insulin and one Omnipod
 for pramlintide delivery.

ICD-10 Classifications

Type 1 diabetes mellitus
Type 1 diabetes mellitus without complications
Type 1 diabetes mellitus with unspecified complications
Type 1 diabetes mellitus with other specified complications
Type 1 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06422325

Device Trial