Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05481034
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2022-07-28
Brief Title:
Simplified Meal Approach Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes
Sponsor:
Lia Bally
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Simplified Meal Approach Study Using Hybrid Closed-loop Insulin Delivery in Youth and Young Adults With Type 1 Diabetes - a Randomised Controlled Two-centre Crossover Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
SMASH
Brief Summary:
The purpose of the study is to examine whether a simplified meal approach as compared to exact carbohydrate counting can alleviate the need of carbohydrate counting without worsening postprandial control in youth and young adults with type 1 diabetes using hybrid closed-loop insulin delivery with the Cambridge Artificial Pancreas FX System CamAPS FX system
Detailed Description:
Optimal glycaemic control is the aim of diabetes care and critical in the prevention of diabetes-related complications Despite advances in diabetes technologies and medications many current youth and young adults YYA with type 1 diabetes T1D are not meeting desired glycaemic targets representing a missed opportunity for improving lifetime outcomes
A variety of factors including peer group influences importance of body image less parental oversight greater risk-taking and performance pressure challenge daily self-management in YYA with T1D Disengagement from care and barriers for optimal glycaemic management in YYA have been mainly shown to be substantially influenced by perceived burden of daily tasks
Although the recently introduced closed-loop systems which link insulin delivery to sensor glucose levels offer promising opportunities to improve glucose control in YYA with T1D they still require the user to estimate carbohydrates The perceived burden of exact carbohydrate counting ECC the limited evidence supporting its glycaemic benefit and corrective potential of algorithm-driven background insulin titration question its necessity during hybrid-closed loop insulin treatment Instead a simplified meal approach SMA which only requires the user to select the meal carbohydrate category smallmediumlarge has the potential to alleviate the burden of ECC during hybrid closed-loop insulin therapy whilst resulting in similar glycaemic benefits
The investigators therefore hypothesize that a simplified meal approach SMA using the CamAPS FX system would achieve comparable glucose control compared with the use of the CamAPS FX system with ECC in YYA with T1D
A variety of factors including peer group influences importance of body image less parental oversight greater risk-taking and performance pressure challenge daily self-management in YYA with T1D Disengagement from care and barriers for optimal glycaemic management in YYA have been mainly shown to be substantially influenced by perceived burden of daily tasks
Although the recently introduced closed-loop systems which link insulin delivery to sensor glucose levels offer promising opportunities to improve glucose control in YYA with T1D they still require the user to estimate carbohydrates The perceived burden of exact carbohydrate counting ECC the limited evidence supporting its glycaemic benefit and corrective potential of algorithm-driven background insulin titration question its necessity during hybrid-closed loop insulin treatment Instead a simplified meal approach SMA which only requires the user to select the meal carbohydrate category smallmediumlarge has the potential to alleviate the burden of ECC during hybrid closed-loop insulin therapy whilst resulting in similar glycaemic benefits
The investigators therefore hypothesize that a simplified meal approach SMA using the CamAPS FX system would achieve comparable glucose control compared with the use of the CamAPS FX system with ECC in YYA with T1D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None