Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469593
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-11
Brief Title:
Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
AID-BEYOND Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics
Status:
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:
AID-BEYOND
Brief Summary:
The goal of this clinical trial is to determine if transitioning to automated insulin delivery AID systems can improve objectively measured sleep quality and quantity and alleviate cardiovascular risk factors in both children and adults diagnosed with type 1 diabetes The main questions it aims to answer are
Does the intervention improve sleep efficiency as measured by the HomeSleepTest EEG based device 4 months after initiation
Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability HRV blood pressure and inflammatory markers
Researchers will compare AID systems to usual treatment including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison Participants will be randomized 11 to either start AID treatment or to continue their usual care The study will be open label
Participants will at baseline and after 4 months
Have taken blood and urine samples to measure metabolic and inflammatory parameters
Perform digital cognitive testing using the CANTAB software
Fill out questionnaires related to quality of life fear of hypoglycemia hypoglycemia awareness eating habits and sleep quality
Wear a blinded CGM for 10 days
Monitor sleep at home using the HomeSleepTest for 3 consecutive nights
Wear a Holter monitor for 24 hours to determine HRV parameters
Measure blood pressure for 24 hours at 30 min intervals
Wear an ActiGraph for 7 days to assess sleep and activity supported by daily electronic sleep diaries
Participants randomized to AID treatment will receive education in the use of the systems
Virtual follow-up visits are scheduled at week 1 5 and 9 for both control and intervention groups during the study following baseline examinations
Does the intervention improve sleep efficiency as measured by the HomeSleepTest EEG based device 4 months after initiation
Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability HRV blood pressure and inflammatory markers
Researchers will compare AID systems to usual treatment including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison Participants will be randomized 11 to either start AID treatment or to continue their usual care The study will be open label
Participants will at baseline and after 4 months
Have taken blood and urine samples to measure metabolic and inflammatory parameters
Perform digital cognitive testing using the CANTAB software
Fill out questionnaires related to quality of life fear of hypoglycemia hypoglycemia awareness eating habits and sleep quality
Wear a blinded CGM for 10 days
Monitor sleep at home using the HomeSleepTest for 3 consecutive nights
Wear a Holter monitor for 24 hours to determine HRV parameters
Measure blood pressure for 24 hours at 30 min intervals
Wear an ActiGraph for 7 days to assess sleep and activity supported by daily electronic sleep diaries
Participants randomized to AID treatment will receive education in the use of the systems
Virtual follow-up visits are scheduled at week 1 5 and 9 for both control and intervention groups during the study following baseline examinations
Detailed Description:
None
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