Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575790
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Simplified Meal Boluses Versus Carbohydrate Counting in Adolescents With Hybrid Closed Loop Systems A Randomized Crossover Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial is to evaluate blood sugar control in patients with type 1 diabetes when using a simple meal bolus strategy small medium large meals compared to carbohydrate counting when on a hybrid closed loop system The main question it aims to answer are
What is the blood sugar time in range when using simple meal boluses versus carbohydrate counting
Participants will
Use the simple meal bolus plan for 4 weeks Do precise carbohydrate counting for 4 weeks Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study
What is the blood sugar time in range when using simple meal boluses versus carbohydrate counting
Participants will
Use the simple meal bolus plan for 4 weeks Do precise carbohydrate counting for 4 weeks Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study
Detailed Description:
This is a prospective randomized crossover trial in adolescents and adults on HCL systems at the Barbara Davis Center for Childhood Diabetes BDC with the objective of testing a new simple meal bolus strategy that would not require carbohydrate counting Given the clear benefit of HCL systems on glycemic control the ability to use an alternative meal bolus strategy may make HCL systems more accessible This is a fixed dose of insulin given at meals for small medium or large meals that would eliminate the need for precise carbohydrate counting and increase access to patients with low numeracy or difficulty with carbohydrate counting Although HCL systems cannot yet provide automatic meal bolus insulin such systems can minimize hyperglycemia through basal modulation and automated correction dosing and should be able to mitigate some of the impact of non-precise carbohydrate coverage The systems can also help prevent hypoglycemia through basal modulation and pausing insulin delivery This study will evaluate glycemic control while using the simple meal bolus strategy as compared to traditional precise carbohydrate counting in addition to assessing feasibility acceptability and impact on meal-related diabetes burden of each meal bolus strategy
The proposed study will be a prospective randomized crossover trial at a single site Study participants will be randomized via REDCap 11 to Group A or Group B with plan for up to a max of 60 total participants to account for drop-out Neither the participants nor the investigators will be blinded to group assignments due to the nature of the study
After enrollment groups will have a 2-week run-in period of usual care At the first study visit patients will upload their pumpCGM data take pre-study surveys and review carbohydrate counting or simple meal boluses Pump settings may be adjusted per provider discretion and typical clinical care Both groups will be instructed to use their systems as they typically would for 4 weeks with the exception of what is entered for carbohydrates for meal boluses Group B will enter the precise carbohydrate count to the best of their ability while the Group A will be instructed to enter an assigned number of carbohydrates based on if the meal is small medium or large Participants will have a follow-up visit in-person virtual or by phone after 4 weeks to provide pump and CGM data adjust insulin dosing as needed and review the new strategy They will have 1 week of usual care as a wash-out period followed by 4 weeks using the opposite strategy Participants will have a final study visit to upload data and take post-study surveys
The proposed study will be a prospective randomized crossover trial at a single site Study participants will be randomized via REDCap 11 to Group A or Group B with plan for up to a max of 60 total participants to account for drop-out Neither the participants nor the investigators will be blinded to group assignments due to the nature of the study
After enrollment groups will have a 2-week run-in period of usual care At the first study visit patients will upload their pumpCGM data take pre-study surveys and review carbohydrate counting or simple meal boluses Pump settings may be adjusted per provider discretion and typical clinical care Both groups will be instructed to use their systems as they typically would for 4 weeks with the exception of what is entered for carbohydrates for meal boluses Group B will enter the precise carbohydrate count to the best of their ability while the Group A will be instructed to enter an assigned number of carbohydrates based on if the meal is small medium or large Participants will have a follow-up visit in-person virtual or by phone after 4 weeks to provide pump and CGM data adjust insulin dosing as needed and review the new strategy They will have 1 week of usual care as a wash-out period followed by 4 weeks using the opposite strategy Participants will have a final study visit to upload data and take post-study surveys
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None