Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422325
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-15
Brief Title:
Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
A Crossover Study to Evaluate InsulinPramlintide Versus Insulin Alone Delivery Strategy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Participants will undergo two 125 hour clinic visits Participants will complete a training on how to start the Dexcom G6 sensor at home Participants will start the G6 sensor the day before each study visit For one visit the system will use insulin only for managing blood sugar For the other study the system will use both insulin and pramlintide The order of the visits will be randomly chosen For 3 days before the insulin and pramlintide visit participants will dose with pramlintide before each meal During the visits participants will wear one or two Omnipods to delivery insulin and insulinpramlintide and a Dexcom G6 CGM The CGM system will provide sensor glucose data every 5 minutes Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy BTLE from the Dexcom G6 to the smartphone master controller every 5 minutes The smartphone will communicate via BTLE to an Omnipod for insulin delivery The closed loop system will receive activity data through a Polar M600 watch worn by the participant Participants will eat breakfast and lunch in clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None