Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024928
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-08-29
Brief Title:
Automated Insulin Delivery AID for Basal Insulin Titration in Type 2 Diabetes
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Short Use of Automated Insulin Delivery AID for Basal Insulin Titration in Type 2 Diabetes A Pilot Study
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:
AID-BIT
Brief Summary:
The purpose of this clinical trial is to test the safety and feasibility of using an Automated Insulin Device AID in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration Participants will be randomized to either the control group or the experimental group If in the experimental group the participant will use an insulin pump with Control-IQ Technology Tandem Diabetes Care for ten days Researchers will compare the glycemic control of the experimental group to the control group
Detailed Description:
The study will involve 20 people with Type 2 Diabetes who are 18 years or older The study will be performed at the University of Virginia UVA with screening procedures taking place either virtually or at the Clinical Research Unit CRU at UVA All participants will undergo a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor CGM Participants will be randomized 11 to either the Control CTR Group or the Experimental EXP Group In the EXP Group participants will use an Automated Insulin Device AID for 10 days in the Basal Insulin Titration BIT Phase then return to their original therapy basal insulin using pen using the new setting in the Maintenance Phase MP The total daily insulin TDI requirement during the BIT Phase will be translated to a basal insulin dose During the same 10 days in the CTR group participants will use an unblinded CGM and will be contacted by a study physician as per standard care to adjust their insulin doses if needed Both groups will then go into a 10-days maintenance period using a blinded CGM Outcomes will be measured in the last 7 days of the BIT and Maintenance Phases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None