Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DEVICEContinuous Glucose Monitor
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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* public insurance * between ages 4-19.99 years inclusive * diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric Endocrinology clinic at Stanford Children's Health * HbA1C greater than 6.5% at enrollment * interested in starting on a continuous glucose monitor * have access to a mobile device that is compatible with CGM applications or willing to use CGM receiver provided
Exclusion criteria
* non-T2D diagnosis * HgA1C \< 6.5% * are not willing to wear CGM * have private health insurance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use | months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time With Glucose Values in Target Range of 70-180 mg/dL | months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit) | — |
| PROMIS Global Health Overall Scale Score | baseline, months 3 and 12 | 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. |
| PedsQL 3.2 Overall Scale Score - Participant Rated | baseline and months 3 and 12 | 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. |
| PedsQL 3.2 Scale Score - Parent Rated | baseline and months 3 and 12 | 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. |
| Mean HbA1C | baseline and months 2,3,6,9 and 12 | HbA1C through 12 months of CGM use |
| Diabetes Technology Attitudes (DTA) - Parent Rated | 1 year (assessed at baseline, 3 months and 12 months) | 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. |
| Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated | baseline, months 3 and 12 | 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). |
| Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated | baseline, months 3 and 12 | 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. |
| Diabetes Technology Attitudes (DTA) - Participant Rated | 1 year (assessed at baseline, 3 months and 12 months) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitor Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitor |
|---|---|
| Age, Continuous | 15.19 years STANDARD_DEVIATION 2.48 |
| Race/Ethnicity, Customized Asian and Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 27 Participants |
| Race/Ethnicity, Customized Non Hispanic Black | 1 Participants |
| Race/Ethnicity, Customized Non Hispanic White | 1 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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)
Population: Participants with available CGM data at each respective timepoint
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continuous Glucose Monitor | Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use | 2-month visit | 7 Participants |
| Continuous Glucose Monitor | Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use | 3-month visit | 2 Participants |
| Continuous Glucose Monitor | Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use | 6-month visit | 1 Participants |
| Continuous Glucose Monitor | Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use | 9-month visit | 0 Participants |
| Continuous Glucose Monitor | Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use | 12-month visit | 0 Participants |
Secondary
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)
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | Diabetes Technology Attitudes (DTA) - Parent Rated | baseline | 3.80 score on a scale |
| Continuous Glucose Monitor | Diabetes Technology Attitudes (DTA) - Parent Rated | 3-month visit | 4.00 score on a scale |
| Continuous Glucose Monitor | Diabetes Technology Attitudes (DTA) - Parent Rated | 12-month visit | 3.60 score on a scale |
Secondary
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)
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | Diabetes Technology Attitudes (DTA) - Participant Rated | 3-month visit | 4.50 score on a scale |
| Continuous Glucose Monitor | Diabetes Technology Attitudes (DTA) - Participant Rated | baseline | 3.78 score on a scale |
| Continuous Glucose Monitor | Diabetes Technology Attitudes (DTA) - Participant Rated | 12-month visit | 4.00 score on a scale |
Secondary
Mean HbA1C
HbA1C through 12 months of CGM use
Time frame: baseline and months 2,3,6,9 and 12
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Continuous Glucose Monitor | Mean HbA1C | 3-month visit | 8.95 percentage of glycosylated hemoglobin | Standard Deviation 2.91 |
| Continuous Glucose Monitor | Mean HbA1C | baseline | 10.18 percentage of glycosylated hemoglobin | Standard Deviation 2.65 |
| Continuous Glucose Monitor | Mean HbA1C | 2-month visit | 10.16 percentage of glycosylated hemoglobin | Standard Deviation 2.69 |
| Continuous Glucose Monitor | Mean HbA1C | 6-month visit | 9.27 percentage of glycosylated hemoglobin | Standard Deviation 2.71 |
| Continuous Glucose Monitor | Mean HbA1C | 9-month visit | 10.04 percentage of glycosylated hemoglobin | Standard Deviation 2.214 |
| Continuous Glucose Monitor | Mean HbA1C | 12-month visit | 9.77 percentage of glycosylated hemoglobin | Standard Deviation 1.22 |
Secondary
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
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | PedsQL 3.2 Overall Scale Score - Participant Rated | Peds QL Overall - month 3 | 59.85 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Overall Scale Score - Participant Rated | Peds QL Overall - baseline | 65.53 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Overall Scale Score - Participant Rated | Peds QL Diabetes - baseline | 58.33 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Overall Scale Score - Participant Rated | Peds QL Diabetes - month 3 | 65.00 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Overall Scale Score - Participant Rated | Peds QL Diabetes - month 12 | 58.33 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Overall Scale Score - Participant Rated | Peds QL Overall - month 12 | 55.30 score on a scale |
Secondary
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
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | PedsQL 3.2 Scale Score - Parent Rated | Peds QL Diabetes - baseline | 65.00 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Scale Score - Parent Rated | Peds QL Diabetes - month 3 | 60.00 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Scale Score - Parent Rated | Peds QL Diabetes - month 12 | 59.17 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Scale Score - Parent Rated | Peds QL Overall - baseline | 64.39 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Scale Score - Parent Rated | Peds QL Overall - month 3 | 59.85 score on a scale |
| Continuous Glucose Monitor | PedsQL 3.2 Scale Score - Parent Rated | Peds QL Overall - month 12 | 57.58 score on a scale |
Secondary
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
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated | baseline | 55.00 score on a scale |
| Continuous Glucose Monitor | Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated | 3-month visit | 59.00 score on a scale |
| Continuous Glucose Monitor | Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated | 12-month visit | 50.50 score on a scale |
Secondary
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
Population: Participants who completed the PAID Teen survey
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated | baseline | 43.50 score on a scale |
| Continuous Glucose Monitor | Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated | 3-month visit | 47.00 score on a scale |
| Continuous Glucose Monitor | Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated | 12-month visit | 52.00 score on a scale |
Secondary
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
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | PROMIS Global Health Overall Scale Score | baseline | 37.20 T-score |
| Continuous Glucose Monitor | PROMIS Global Health Overall Scale Score | 3-month visit | 35.60 T-score |
| Continuous Glucose Monitor | PROMIS Global Health Overall Scale Score | 12-month visit | 32.40 T-score |
Secondary
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)
Population: Participants with available CGM data at each respective timepoint
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Continuous Glucose Monitor | Time With Glucose Values in Target Range of 70-180 mg/dL | 2-month visit | 71 percentage of time |
| Continuous Glucose Monitor | Time With Glucose Values in Target Range of 70-180 mg/dL | 3-month visit | 45.5 percentage of time |
| Continuous Glucose Monitor | Time With Glucose Values in Target Range of 70-180 mg/dL | 6-month visit | 59 percentage of time |
| Continuous Glucose Monitor | Time With Glucose Values in Target Range of 70-180 mg/dL | 9-month visit | 28.5 percentage of time |
| Continuous Glucose Monitor | Time With Glucose Values in Target Range of 70-180 mg/dL | 12-month visit | 42 percentage of time |