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.
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 and/or 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Continuous Glucose Monitor System for people with Type 2 Diabetes
University of California San Francisco (UCSF)
San Francisco, California, United States
Ability to use CGM
Use of CGM measured by number of hours participants in the intervention arm wear the CGM device and view data on the mobile application.
Time frame: Measured at 6 months
Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)
The perception that CGM use is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). Greater the score, higher the acceptability
Time frame: Measured at 6 months
Appropriateness of CGM use measured with Intervention Appropriateness Measure
The perceived fit of the CGM to improve diabetes related metrics measured with the 4-item Intervention Appropriateness Measure (IAM). Greater the score, higher the appropriateness of CGM use
Time frame: Measured at 6 months
Feasibility of CGM use measured with Feasibility of Intervention Measure.
The extent to which a CGM study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). The higher the score, the greater the feasibility of CGM use
Time frame: Measured at 6 months
Glycemic change
Change in HbA1C at 6 months adjusted for the baseline value youth with T2D.
Time frame: Baseline (0) to 6 months
Time in target glucose range
Time spent in target glucose range of 70 to 180 mg/dL
Time frame: Baseline (0) to 6 months
Time above high glucose range
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percent of readings and time \>250 mg/dL
Time frame: Baseline (0) to 6 months
Time above glucose range
percent of readings and time 181-250 mg/dL
Time frame: Baseline (0) to 6 months
Time below glucose range
percent of readings and time 54-69 mg/dL
Time frame: Baseline (0) to 6 months
Time below low glucose range
percent of readings and time \<54 mg/dl
Time frame: Baseline (0) to 6 months
Glucose management indicator
CGM metric that indicates average blood glucose
Time frame: Baseline (0) to 6 months
Co-efficient of variation of glucose
CGM metric that measures variability in CGM values
Time frame: Baseline (0) to 6 months
Change in BMI
Change in BMI SDS over the course of the study
Time frame: Baseline (0) to 6 months
Frequency of taking diabetes medications
Self-reported medication adherence in the past week before visit
Time frame: Baseline (0) to 6 months
Starting or stopping medications
Percentage of subjects with addition or removal of diabetes medications
Time frame: Baseline (0) to 6 months
Titration of insulin dosing by provider
Percentage of subjects who receive insulin dose titration
Time frame: Baseline (0) to 6 months
Dietary measures
Change in score on SEARCH for Diabetes in Youth food frequency questionnaire. This is a 85 question survey ( Mayer-Davis EJ, Nichols M, Liese AD et al. (2006) Dietary intake among youth with diabetes: the SEARCH for Diabetes in Youth Study. J Am Diet Assoc.2006)
Time frame: Baseline (0) to 6 months
Physical activity measures
Number of minutes of physical activity in the past week before visit. The greater the value the better the score.
Time frame: Baseline (0) to 6 months
Quality of Life score on survey
Pediatric Quality of Life Inventory Diabetes Module score. 33 item score. The greater the value the better the score.
Time frame: Baseline (0) to 6 months
Problem Areas in Diabetes
Problem Areas In Diabetes (PAID) Scale. 20 question survey. Higher the score, the worse the outcome
Time frame: Baseline (0) to 6 months