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| ID | Type | Description | Link |
|---|---|---|---|
| HD041919-01, | |||
| HD041915-01, | |||
| HD041890, | |||
| HD041918-01, | |||
| HD041908-01, | |||
| HD041906-01, | |||
| M01RR000069 | U.S. NIH Grant/Contract | View source | |
| RR00059, | |||
| RR 06022, | |||
| RR00070-41 |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.
On the day of enrollment, a hemoglobin A1c level will be obtained, and potential subjects will be evaluated for study eligibility through the elicitation of a medical history and performance of a physical examination by a study investigator.
The subject will return for a second visit about 6 weeks after the enrollment visit. At this visit, quality of life questionnaires will be completed and a CGM sensor will be inserted. The monitor will be blinded so that the glucose values cannot be seen. The parent will be instructed on insertion, calibration, and care of the CGM.
The subject will return for a randomization visit 14 to 28 days after the blinded CGM was initiated.
Both groups will have follow-up visits at 1,4,8,13,19, and 26 weeks (+/- 1 week) plus one contact between each visit (including one phone contact between the second visit and the one week visit) to review their diabetes management.
In the 13th and 26th weeks, the Control Group will use a blinded CGM for one week. The CGM Group will continue to use the blinded CGM. The Control Group will return the blinded CGM to the clinic after a week. The data will be reviewed by personnel who are not involved in the care of the subject to determine if additional blinded sensor data are needed. The blinded data will not be reviewed by the study personnel for management decisions until the end of the first 6 months of the study.
Following the 26-week visit:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | continuous glucose monitoring |
|
| 2 | Active Comparator | Standard glucose monitoring with a home glucose meter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitor | Device | Daily use of a continuous glucose monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Severe Hypoglycemic Events Experienced by Participants | 26 weeks | |
| CGM Glucose Values (mg/dL) | Percentage of sensors values in range (71 mg/dL to 180 mg/dL) | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Diabetes diagnosed <6 months of age
Use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:
Home use of CGM in past 6 months.
Participation in an intervention study (including psychological studies) in past 6 weeks.
Another member of the same household is participating in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Roy W Beck, MD, PhD | Jaeb Center for Health Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Yale University, School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22210571 | Result | Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, White NH, Weinzimer SA, Tamborlane W, Kollman C; Diabetes Research in Children Network (DirecNet) Study Group. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. Diabetes Care. 2012 Feb;35(2):204-10. doi: 10.2337/dc11-1746. Epub 2011 Dec 30. | |
| 26895885 | Derived |
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Prior to randomization, enrolled participants had a run-in period of 6 weeks to optimize glycemic control prior to CGM use. A blinded CGM was then used for 2-4 weeks prior to randomization to familiarize participants and parents with the device and to collect data for assessment of baseline glycemic control.
Recruitment occurred between January 2009 and December 2010 at the 5 participating DirecNet clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Montoring | Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter >=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Home blood glucose monitor | Device | Home monitoring 3 or more times a day |
|
|
| Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL) | CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data. | 26 weeks |
| Measures of Variability: Standard Deviation (SD) | standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported. | 26 weeks |
| Measures of Variability: Mean Absolute Rate of Change | mean absolute rate of change | 26 weeks |
| Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE) | Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55 | 26 weeks |
| Parental Quality of Life Measures: Hypoglycemia Fear Survey | The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0-100 with higher score denoting more fear. The results reported below are the values at 26 weeks. | 26 weeks |
| Parental Quality of Life Measures: PAID (Problem Areas in Diabetes) | The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks. | 26 weeks |
| Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale | The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1-4. Higher score denotes fewer problems in the past month. | 26 weeks |
| Parental Quality of Life Measures: CGM Satisfaction Scale | Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis) JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679-684 | 26 weeks |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Children's Hospital of Iowa, Department of Pediatrics | Iowa City | Iowa | 52242 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Triolo TM, Maahs DM, Pyle L, Slover R, Buckingham B, Cheng P, DiMeglio LA, Bremer AA, Weinzimer SA, Chase HP; Diabetes Research in Children Network (DirecNet) and Type 1 Diabetes TrialNet Study Groups. Effects of Frequency of Sensor-Augmented Pump Use on HbA1c and C-Peptide Levels in the First Year of Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):e61-2. doi: 10.2337/dc15-2201. Epub 2016 Feb 19. No abstract available. |
| 24130350 | Derived | Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15. |
| FG001 | Standard Glucose Monitoring With Home Glucose Meter | Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Glucose Montoring | Treatment group |
| BG001 | Standard Glucose Monitoring With a Home Glucose Meter | Control Group |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events | Excludes five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models | Posted | Number | participants | 26 weeks |
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| Secondary | Number of Severe Hypoglycemic Events Experienced by Participants | Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization. | Posted | Number | events | 26 weeks |
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| Secondary | CGM Glucose Values (mg/dL) | Percentage of sensors values in range (71 mg/dL to 180 mg/dL) | CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data | Posted | Median | Inter-Quartile Range | percentage of sensor readings | 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL) | CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data. | Posted | Median | Inter-Quartile Range | percentage of sensor readings | 26 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measures of Variability: Standard Deviation (SD) | standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported. | CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data. | Posted | Median | Inter-Quartile Range | mg/dL | 26 weeks |
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| Secondary | Measures of Variability: Mean Absolute Rate of Change | mean absolute rate of change | CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data | Posted | Median | Inter-Quartile Range | mg/dL per minute | 26 weeks |
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| Secondary | Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE) | Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55 | CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data | Posted | Median | Inter-Quartile Range | percentage of median | 26 weeks |
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| Secondary | Parental Quality of Life Measures: Hypoglycemia Fear Survey | The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0-100 with higher score denoting more fear. The results reported below are the values at 26 weeks. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks |
|
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| Secondary | Parental Quality of Life Measures: PAID (Problem Areas in Diabetes) | The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks |
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| Secondary | Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale | The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1-4. Higher score denotes fewer problems in the past month. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks |
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| Secondary | Parental Quality of Life Measures: CGM Satisfaction Scale | Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis) JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679-684 | Posted | Mean | Standard Deviation | units on a scale | 26 weeks |
|
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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 Montoring | Treatment group | 6 | 74 | 3 | 74 | ||
| EG001 | Standard Glucose Monitoring With a Home Glucose Meter | Control Group | 6 | 72 | 6 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Infections and infestations |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Diabetic ketoacidosis | Metabolism and nutrition disorders |
| |||
| Homicidal ideation | Psychiatric disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hypoglycemia | Metabolism and nutrition disorders |
| |||
| Pharyngotonsillitis | Infections and infestations |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katrina Ruedy | Jaeb Center for Health Research | 813-975-8690 | direcnet@jaeb.org |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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