The purpose of this pilot feasibility study is to provide continued CGM access to youth with type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose metrics and patient reported outcomes (PROs). The investigators will pilot and refine a program to test the hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose metrics and PROs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care
Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.
Stanford Children's Health
Palo Alto, California, United States
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use
Time frame: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)
Mean HbA1C
HbA1C through 12 months of CGM use
Time frame: baseline and months 2,3,6,9 and 12
Time With Glucose Values in Target Range of 70-180 mg/dL
Time frame: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)
PROMIS Global Health Overall Scale Score
PROMIS Global Health (7 questions, Minimum=1, maximum=5 for each question, higher score for physical health questions is better outcome, higher score for mental health is worse outcome). Scores for each question were summed then converted to a t-score (overall range 16 to 67.5, higher score = better health). A score of 50 is the average for the United States general population with a standard deviation of 10. A score below 22 in this study would result in a referral to social work or diabetes psychology.
Time frame: baseline, months 3 and 12
PedsQL 3.2 Overall Scale Score - Participant Rated
Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by participants to create an overall score range of 0 to 100, higher scores correspond to lower problems.
Time frame: baseline and months 3 and 12
PedsQL 3.2 Scale Score - Parent Rated
Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by parents to create an overall score range of 0 to 100, higher scores correspond to lower problems. Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.
Time frame: baseline and months 3 and 12
Diabetes Technology Attitudes (DTA) - Participant Rated
The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5
Time frame: 1 year (assessed at baseline, 3 months and 12 months)
Diabetes Technology Attitudes (DTA) - Parent Rated
The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5 Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.
Time frame: 1 year (assessed at baseline, 3 months and 12 months)
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated
Problem Areas in Diabetes - survey Teen version with 14 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 14 to 84 (higher score is worse outcome).
Time frame: baseline, months 3 and 12
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated
Problem Areas in Diabetes - survey Teen Parent version with 15 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 15 to 90 (higher score is worse outcome). Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.
Time frame: baseline, months 3 and 12
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