Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600776
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study Comparing the Efficacy of Dosing Ultra Rapid Insulin Lispro in a Medtronic 780G Hybrid Closed Loop System At Mealtime or Postmeal
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This is a pilot study to compare premeal to postmeal dosing of ultra rapid lispro insulin URLi used in a MiniMed 780G system hybrid closed loop system Subjects with type 1 diabetes mellitus T1DM already using a 780G hybrid closed loop system with URLi will be included After signing a remote digital informed consent a baseline record of the MiniMed 780G system will be downloaded from the Medtronic digital platform Carelink system 1 and subjects will be asked to fill an online questionnaire regarding their time of insulin dosing preferences and a 3-day online food diary 2 During the intervention period subjects will be asked to provide a bolus dose of insulin only at the end of meals for up to 4 weeks During the last week of the intervention period subjects will be asked to fill out a 3-day online food diary 2 At the end of the intervention period- a Carelink report 1 will be collected remotely and subjects will be asked to fill again the online questionnaire regarding their time of dosing preferences
1 Primary Objective To assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring
2 Secondary Objective To assess patient dosing preferences and the effect of premeal dosing vs post-meal dosing on patient reported outcomes
Ref
1 carelinkmedtroniceu
2 NutRatiocom
1 Primary Objective To assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring
2 Secondary Objective To assess patient dosing preferences and the effect of premeal dosing vs post-meal dosing on patient reported outcomes
Ref
1 carelinkmedtroniceu
2 NutRatiocom
Detailed Description:
None
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