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The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.
Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c > = 8 % who are also naive to CGMS use will be recruited from the diabetes outpatient population followed at Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20 subjects will be assigned to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose Meter | Experimental | Continuing Glucose Monitoring Device |
|
| No Glucose Meter | Active Comparator | Average Blood glucose measure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGMS Device | Device |
|
| |
| No Device |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months | The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months. | Baseline, 3 Months |
| Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months | HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change. | Baseline, 3 Months |
| Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months | Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline. | Baseline, 3 Months |
| Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months | There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score. | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonita Franklin, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Medical Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glucose Meter | Continuing Glucose Monitoring Device CGMS Device |
| FG001 | No Glucose Meter | Average Blood glucose measure No Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glucose Meter | Continuing Glucose Monitoring Device CGMS Device |
| BG001 | No Glucose Meter | Average Blood glucose measure No Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months | The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months. | Posted | Mean | Full Range | score on a scale | Baseline, 3 Months |
|
For 3 months after randomization
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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 | Glucose Meter | Continuing Glucose Monitoring Device CGMS Device | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeniece Ilkowitz RN, MA, CDE | NYU Langone Health | 212-263-9910 | Jeniece.ilkowitz@nyulangone.org |
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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 | Apr 26, 2018 | Feb 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Average Blood glucose measure No Device |
|
|
| Primary | Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months | HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change. | Posted | Mean | Full Range | mmol/mol | Baseline, 3 Months |
|
|
|
| Primary | Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months | Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline. | Posted | Mean | Full Range | mg/dl | Baseline, 3 Months |
|
|
|
| Primary | Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months | There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score. | Posted | Mean | Full Range | units on a scale | Baseline, 3 months |
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | No Glucose Meter | Average Blood glucose measure No Device | 0 | 3 | 0 | 3 | 0 | 3 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |