Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236607
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-01-24
Brief Title:
Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Minoritized individuals with type 1 diabetes T1D have approximately 2 higher average A1c levels and twice the rate of hospitalizations complications and mortality as their white counterparts However the efficacy trials establishing the benefits of hybrid closed loop HCL pump therapy in T1D have been in more socially advantaged and predominantly non-Hispanic white patients Use of this technology by individuals with T1D from underserved communities remains very low
The investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria including markedly elevated A1c and longer follow up than the previous HCL efficacy trials - to evaluate the benefits safety risks and treatment complications of HCL use in underserved adults with T1D A comprehensive mixed-methods approach will be implemented to capture information about the user experience
Participants will be randomized 31 ratio to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy Subjects will be followed for 9 months to collect data on effectiveness glucose time-in-range 70-180 mgdL and time 70 mgdL safety diabetic ketoacidosis and severe hypoglycemia events and patient experience using the systems including benefits and burdens the impact of life stressors on HCL use and how the match between HCL system functionality and the individuals needs and expectations impacts on user experience
The investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria including markedly elevated A1c and longer follow up than the previous HCL efficacy trials - to evaluate the benefits safety risks and treatment complications of HCL use in underserved adults with T1D A comprehensive mixed-methods approach will be implemented to capture information about the user experience
Participants will be randomized 31 ratio to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy Subjects will be followed for 9 months to collect data on effectiveness glucose time-in-range 70-180 mgdL and time 70 mgdL safety diabetic ketoacidosis and severe hypoglycemia events and patient experience using the systems including benefits and burdens the impact of life stressors on HCL use and how the match between HCL system functionality and the individuals needs and expectations impacts on user experience
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK138309-01 | NIH | None | httpsreporternihgovquickSearch1R01DK138309-01 |