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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitor | Other | All participants will be included in this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean HbA1C | HbA1C through 12 months of CGM use | baseline and months 2,3,6,9 and 12 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sejal Shah, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Children's Health | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40974209 | Derived | Shah S, Tanenbaum ML, Loyola A, Sala NGL, Darji H, Hanes S, Bishop FK, Hood KK, Maahs DM. Use of Continuous Glucose Monitors in Publicly Insured Youth With Type 2 Diabetes: A 12-month Pilot and Feasibility Study. J Diabetes Sci Technol. 2025 Sep 20:19322968251368366. doi: 10.1177/19322968251368366. Online ahead of print. |
| Label | URL |
|---|---|
| PROMIS scoring manual | View source |
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All of the individual participant data collected during the trial after deidentification
immediately following publication. No end date.
Researchers who provide a methodologically sound proposal, for purpose of achieving aims in the approved proposal. Proposals should be directed to the protocol director and data sharing requests will need to follow current protocols in place at Stanford University.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use | Participants with available CGM data at each respective timepoint | Posted | Count of Participants | Participants | months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit) |
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12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sejal Shah, MD | Stanford University | 650-498-7351 | sshah2@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2021 | Jun 7, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2022 | Oct 12, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Patient Reported Outcome Questionnaires | Other | Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points. |
|
| 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. | 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. | 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. | 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 | 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. | 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). | 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. | baseline, months 3 and 12 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Mean HbA1C | HbA1C through 12 months of CGM use | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | baseline and months 2,3,6,9 and 12 |
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| Secondary | Time With Glucose Values in Target Range of 70-180 mg/dL | Participants with available CGM data at each respective timepoint | Posted | Median | Inter-Quartile Range | percentage of time | months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit) |
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| 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. | Participants with available data at each respective timepoint | Posted | Median | Inter-Quartile Range | T-score | baseline, months 3 and 12 |
|
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| 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. | Participants with available data at each respective timepoint | Posted | Median | Inter-Quartile Range | score on a scale | baseline and months 3 and 12 |
|
|
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| 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. | Participants with available data at each respective timepoint | Posted | Median | Inter-Quartile Range | score on a scale | baseline and months 3 and 12 |
|
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|
| 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 | Participants with available data at each respective timepoint | Posted | Median | Inter-Quartile Range | score on a scale | 1 year (assessed at baseline, 3 months and 12 months) |
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| 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. | Participants with available data at each respective timepoint | Posted | Median | Inter-Quartile Range | score on a scale | 1 year (assessed at baseline, 3 months and 12 months) |
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| 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). | Participants who completed the PAID Teen survey | Posted | Median | Inter-Quartile Range | score on a scale | baseline, months 3 and 12 |
|
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| 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. | Participants with available data at each respective timepoint | Posted | Median | Inter-Quartile Range | score on a scale | baseline, months 3 and 12 |
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| 1 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D004700 | Endocrine System Diseases |
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| 3-month visit |
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| 6-month visit |
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| 9-month visit |
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| 12-month visit |
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| 6-month visit |
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| 9-month visit |
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| 12-month visit |
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| 12-month visit |
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| Peds QL Diabetes - month 12 |
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| Peds QL Overall - baseline |
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| Peds QL Overall - month 3 |
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| Peds QL Overall - month 12 |
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| Peds QL Diabetes - month 12 |
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| Peds QL Overall - baseline |
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| Peds QL Overall - month 3 |
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| Peds QL Overall - month 12 |
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| 12-month visit |
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| 12-month visit |
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| Title | Measurements |
|---|---|
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| 12-month visit |
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