Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089070
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-10-12
Brief Title:
Continuous Glucose Monitoring System Feasibility in Youth With T2D
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes FREE_CGM
Status:
RECRUITING
Status Verified Date:
2024-01
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:
FREE_CGM
Brief Summary:
The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor CGM system and whether this will influence behavior and management decisions There will be 30 participants enrolled in the study 20 in the treatment arm and 10 in the control The length of study participation will be 6 months for each participant
Detailed Description:
At the beginning of the study participants will be asked to complete surveys where demographic clinical and behavioral data will be collected We will ask participants to wear a glucose sensor that is blinded for 14-days so that we can gather baseline data about blood sugar levels
Participants must wear the CGM sensor for at least 10 days out of the 14 days of the blinding period to move on to the next part of the study After wearing the blinded sensor the study team will place participants in one of two groups
One group intervention group will be shown how to use the sensors along with the FreeStyle Libre App and the other group control group will continue with their standard diabetes care without using the CGM system Participants will be randomized into one of the study groups described below Participants will have a 2 in 3 chance of being placed in the group who receives the glucose sensor and will have access to the data
Group 1 participants will receive the FreeStyle Libre 3 sensor and have access to the data on their smartphone during the study
Group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer Participants will be asked to perform 2 checks a day fasting and 2 hours post dinner as is standard practice
If randomized to group 1 participants will receive the FreeStyle Libre 3 system with education from the study coordinator on how to insert sensors and view data on the connected mobile app
Standardized study education materials with suggestions on how to react to the data such as avoidance of sugary beverages or increased physical activity will also be provided
Participants will be asked to wear the sensor for the rest of the 6-month participation in the study
If randomized to group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer Participants will also receive standardized study education materials about reacting to glucose values Participants will be asked to perform 2 glucose checks a day fasting and 2 hours after a meal as is standard practice
As a part of usual care participants will come to clinic 3 months after starting the study to meet with their usual diabetes provider and a diabetes educator We will also have a phone check-in visit with participants at 1 month 2 months 4 months and 5 months after starting the study
For month 3 and month 6 of the study participants will already be in clinic to see their regular diabetes provider and we can combine their clinic and research visit At the end of the study participants will be invited to come to an optional online focus group to talk about the technology that you used with the study researchers
Participants will be able to share the things that they liked or did not like about the technology The researchers will speak with approximately 5-7 participants at a time in a group The conversation will be recorded via a secure videoconference so that the researchers can remember everything that was said The audio files will be stored in secure locations and participants full names will not be used in the sessions
Additional notes
If participants do not have the appropriate device to download the app a reader will be provided by the study team
Diagnoses medication history medical history and lab results will be collected from the medical record for research purposes
A Random number generator will be used for randomization
The study coordinators andor the investigators will distribute the participant surveys
The study coordinators and the investigators will conduct the focus groups
There are no in patient procedures
For younger participants who may not be able to complete surveys by themselves parents or guardians may assist younger participants to complete the surveys
Parents will be requested to complete the parent reports
Participants must wear the CGM sensor for at least 10 days out of the 14 days of the blinding period to move on to the next part of the study After wearing the blinded sensor the study team will place participants in one of two groups
One group intervention group will be shown how to use the sensors along with the FreeStyle Libre App and the other group control group will continue with their standard diabetes care without using the CGM system Participants will be randomized into one of the study groups described below Participants will have a 2 in 3 chance of being placed in the group who receives the glucose sensor and will have access to the data
Group 1 participants will receive the FreeStyle Libre 3 sensor and have access to the data on their smartphone during the study
Group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer Participants will be asked to perform 2 checks a day fasting and 2 hours post dinner as is standard practice
If randomized to group 1 participants will receive the FreeStyle Libre 3 system with education from the study coordinator on how to insert sensors and view data on the connected mobile app
Standardized study education materials with suggestions on how to react to the data such as avoidance of sugary beverages or increased physical activity will also be provided
Participants will be asked to wear the sensor for the rest of the 6-month participation in the study
If randomized to group 2 participants will be asked to continue standard blood glucose monitoring with a glucometer Participants will also receive standardized study education materials about reacting to glucose values Participants will be asked to perform 2 glucose checks a day fasting and 2 hours after a meal as is standard practice
As a part of usual care participants will come to clinic 3 months after starting the study to meet with their usual diabetes provider and a diabetes educator We will also have a phone check-in visit with participants at 1 month 2 months 4 months and 5 months after starting the study
For month 3 and month 6 of the study participants will already be in clinic to see their regular diabetes provider and we can combine their clinic and research visit At the end of the study participants will be invited to come to an optional online focus group to talk about the technology that you used with the study researchers
Participants will be able to share the things that they liked or did not like about the technology The researchers will speak with approximately 5-7 participants at a time in a group The conversation will be recorded via a secure videoconference so that the researchers can remember everything that was said The audio files will be stored in secure locations and participants full names will not be used in the sessions
Additional notes
If participants do not have the appropriate device to download the app a reader will be provided by the study team
Diagnoses medication history medical history and lab results will be collected from the medical record for research purposes
A Random number generator will be used for randomization
The study coordinators andor the investigators will distribute the participant surveys
The study coordinators and the investigators will conduct the focus groups
There are no in patient procedures
For younger participants who may not be able to complete surveys by themselves parents or guardians may assist younger participants to complete the surveys
Parents will be requested to complete the parent reports
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None