Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04149262
Status:
UNKNOWN
Last Update Posted:
2019-11-04
First Post:
2019-10-26
Brief Title:
Fiasp Versus NovoRapid in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
An Open Label Single-center Randomized Cross-over Trial Comparing the Efficacy and Safety of Faster-acting Insulin Aspart Fiasp Compared to Insulin Aspart NovoRapid Used in the Medtronic MiniMed 640G Insulin Pump Equipped With Sensor
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
NOT_YET_RECRUITING
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:
This is an exploratory single-center open label randomized complete cross-over trial comparing safety and efficacy of Fiasp versus NovoRapid when used in the Medtronic MiniMed 640G system in pediatric subjects with Type 1 Diabetes Mellitus
Detailed Description:
This study is designed to compare Fiasp to NovoRapid in children with T1DM wearing MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter in terms of glycemic control with a focus on post-prandial ½-hour and 1-hour plasma glucose levels The investigators hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp treatment period
Half randomized subjects will have a 4 weeks screening period using NovoRapid and then 4 weeks treatment period with Fiasp whereas the rest of the participants will start the trial period with 4 weeks using Fiasp followed by 4 weeks in NovoRapid
Half randomized subjects will have a 4 weeks screening period using NovoRapid and then 4 weeks treatment period with Fiasp whereas the rest of the participants will start the trial period with 4 weeks using Fiasp followed by 4 weeks in NovoRapid
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?:
False
Is an FDA AA801 Violation?:
None