Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Staffing shortages
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this observational study is to test the Garmin Vivosmart in children and youth (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer are:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garmin physical activity tracker | Other | The Garmin physical activity tracker is worn like a watch on the user. The tracker assesses several physical states, indicates when the body is at optimal time for activity or when the body needs to rest. The tracker also monitors stress levels and prompts relaxation when appropriate. The tracker sets goals with participants based on previously completed activity. The tracker alerts participants after a period of inactivity, encourages regular movement throughout the day, and decreases the amount of time spent sedentary. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) Amount | Minutes per Day of MVPA | Up to 365 days +- 30 days |
| Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | 90 days +- 30 days |
| Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | 180 days +- 30 days |
| Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | 365 +-30 days |
| Change in Time in Range | Time where blood glucose is in an appropriate range (and other glucose measurements) | Over 90, 180, and 365 +- 30 days |
| Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | 90 +- 30 days |
| Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | 180 +- 30 days |
| Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range |
| Measure | Description | Time Frame |
|---|---|---|
| Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | 0 months |
| Self Reported Physical Activity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Youth (8-21 YO) diagnosed with T1D and parents of youth (8-17 YO)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Clements, MD | Children's Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34346318 | Background | Cescon M, Choudhary D, Pinsker JE, Dadlani V, Church MM, Kudva YC, Doyle Iii FJ, Dassau E. Activity detection and classification from wristband accelerometer data collected on people with type 1 diabetes in free-living conditions. Comput Biol Med. 2021 Aug;135:104633. doi: 10.1016/j.compbiomed.2021.104633. Epub 2021 Jul 12. | |
| 35297778 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Primary Analysis Arm | Youth (8-21 YO) diagnosed with T1D. |
| FG001 | Parent Arm | Parents of youth (8-18YO) diagnosed with T1D. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Primary Analysis Arm | Youth (8-21 YO) diagnosed with T1D |
| BG001 | Parent Arm | Parents of youth (8-18 YO) diagnosed with T1D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P). |
| 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 | Moderate to Vigorous Physical Activity (MVPA) Amount | Minutes per Day of MVPA | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | Up to 365 days +- 30 days |
|
|
1 year
Only adverse events were monitored for youth as parents only completed Hypoglycemic Fear Scale II for Parents (HFS-P) for the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Analysis Arm | Youth (8-21 YO) diagnosed with T1D. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priscilla Connell | Children's Mercy Research Institute | 8166014543 | Endocrine-RisingT1deAlliance@cmh.edu |
Not provided
| 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 | Mar 11, 2025 | Jul 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2025 | Jul 31, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 365 +- 30 days |
| Minutes of Sleep Per Day | Minutes of Sleep per Day | Up to 365 days +- 30 days |
Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. |
| 6 months |
| Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better. | 12 months |
| Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | 0 months |
| Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | 6 months |
| Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | 12 months |
| Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | 0 months |
| Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | 6 months |
| Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | 12 months |
| Change in Self Reported Physical Activity Levels | Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | Between 0, 6, and 12 months |
| Change in How Participants Feel About Episodes of Hypoglycemia | Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome | Between 0, 6, and 12 months |
| Change in How Parents Feel About Episodes of Hypoglycemia in Their Children | Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | Between 0, 6, and 12 months |
| Grimes A, Lightner JS, Eighmy K, Steel C, Shook RP, Carlson J. Decreased Physical Activity Among Youth Resulting From COVID-19 Pandemic-Related School Closures: Natural Experimental Study. JMIR Form Res. 2022 Apr 15;6(4):e35854. doi: 10.2196/35854. |
| 34682355 | Background | Jaggers JR, McKay T, King KM, Thrasher BJ, Wintergerst KA. Integration of Consumer-Based Activity Monitors into Clinical Practice for Children with Type 1 Diabetes: A Feasibility Study. Int J Environ Res Public Health. 2021 Oct 10;18(20):10611. doi: 10.3390/ijerph182010611. |
| 32105515 | Background | Ozaslan B, Patek SD, Breton MD. Impact of Daily Physical Activity as Measured by Commonly Available Wearables on Mealtime Glucose Control in Type 1 Diabetes. Diabetes Technol Ther. 2020 Oct;22(10):742-748. doi: 10.1089/dia.2019.0517. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P). | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P). | Count of Participants | Participants |
|
| Primary | Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 90 days +- 30 days |
|
|
| Primary | Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 180 days +- 30 days |
|
|
| Primary | Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 365 +-30 days |
|
|
| Primary | Change in Time in Range | Time where blood glucose is in an appropriate range (and other glucose measurements) | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | Over 90, 180, and 365 +- 30 days |
|
|
| Primary | Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 90 +- 30 days |
|
|
| Primary | Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 180 +- 30 days |
|
|
| Primary | Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 365 +- 30 days |
|
|
| Primary | Minutes of Sleep Per Day | Minutes of Sleep per Day | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | Up to 365 days +- 30 days |
|
|
| Secondary | Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 0 months |
|
|
| Secondary | Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 6 months |
|
|
| Secondary | Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better. | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 12 months |
|
|
| Secondary | Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 0 months |
|
|
| Secondary | Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 6 months |
|
|
| Secondary | Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 12 months |
|
|
| Secondary | Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 0 months |
|
|
| Secondary | Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 6 months |
|
|
| Secondary | Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | 12 months |
|
|
| Secondary | Change in Self Reported Physical Activity Levels | Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | Between 0, 6, and 12 months |
|
|
| Secondary | Change in How Participants Feel About Episodes of Hypoglycemia | Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | Between 0, 6, and 12 months |
|
|
| Secondary | Change in How Parents Feel About Episodes of Hypoglycemia in Their Children | Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data. | Posted | Between 0, 6, and 12 months |
|
|
| 24 |
| 0 |
| 24 |
| 3 |
| 24 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|