Diabetes Mellitus, Type 1
Conditions
Keywords
Continuous Glucose Monitor
Brief summary
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.
Detailed description
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. * Subjects who have been compliant with use of the CGM and HGM will be randomized to one of two treatment groups: CGM Group or Control Group * For the CGM Group, the CGM, HGM, and pump data (if applicable) will be reviewed and changes will be made to diabetes management as needed. Parents will be taught to use the protocol-developed instructions for changes to diabetes management to be used in real time based on CGM and HGM data. Instructions for downloading the CGM and HGM will be provided to subjects with a home computer. * For the Control Group, a HGM and test strips will be provided. The HGM and pump data (if applicable) will be reviewed and changes will be made in diabetes management as needed. The blinded CGM data will be downloaded but will not be reviewed by study personnel until the end of the first 6 months of the study. Parents will be taught to use the protocol-developed instructions for how to make changes to diabetes management based on HGM data. 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. * Both groups will download device data on a weekly basis (if the subject has a computer). Subjects with email access will be instructed to email the downloaded data to the clinical center prior to each phone contact. * For both groups, at each visit, the HGM and pump (if applicable) will be downloaded and for the CGM group, the CGM will be downloaded. 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: * Subjects in the RT-CGM Group will continue to use the CGM. * Subjects in the Control Group will be provided with a CGM and sensors after the week of blinded use and will have visits after 1 week and 4 weeks, with a phone contact during the first and second weeks. * Both groups will have visits after 13 weeks and 26 weeks
Interventions
DEVICEContinuous glucose monitor
Daily use of a continuous glucose monitor
DEVICEHome blood glucose monitor
Home monitoring 3 or more times a day
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months 2. Age \>4.0 to \<10.0 years 3. HbA1c \>= 7.0% 4. Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)
Exclusion criteria
1. Diabetes diagnosed \<6 months of age 2. 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. 3. The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol: * Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment) * Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not exclude subjects from enrollment) 4. Home use of CGM in past 6 months. 5. Participation in an intervention study (including psychological studies) in past 6 weeks. 6. Another member of the same household is participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events | 26 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Severe Hypoglycemic Events Experienced by Participants | 26 weeks | — |
| CGM Glucose Values (mg/dL) | 26 weeks | Percentage of sensors values in range (71 mg/dL to 180 mg/dL) |
| Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL) | 26 weeks | 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. |
| Measures of Variability: Standard Deviation (SD) | 26 weeks | 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. |
| Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale | 26 weeks | 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. |
| Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE) | 26 weeks | 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 |
| Parental Quality of Life Measures: Hypoglycemia Fear Survey | 26 weeks | 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. |
| Parental Quality of Life Measures: PAID (Problem Areas in Diabetes) | 26 weeks | 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. |
| Parental Quality of Life Measures: CGM Satisfaction Scale | 26 weeks | 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 |
| Measures of Variability: Mean Absolute Rate of Change | 26 weeks | mean absolute rate of change |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between January 2009 and December 2010 at the 5 participating DirecNet clinical centers.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Montoring Treatment group | 74 |
| Standard Glucose Monitoring With a Home Glucose Meter Control Group | 72 |
| Total | 146 |
Baseline characteristics
| Characteristic | Standard Glucose Monitoring With a Home Glucose Meter | Continuous Glucose Montoring | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 72 Participants | 74 Participants | 146 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.5 years STANDARD_DEVIATION 1.7 | 7.5 years STANDARD_DEVIATION 1.8 | 7.5 years STANDARD_DEVIATION 1.7 |
| Region of Enrollment United States | 72 participants | 74 participants | 146 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 67 Participants |
| Sex: Female, Male Male | 39 Participants | 40 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 74 | 6 / 72 |
| serious Total, serious adverse events | 6 / 74 | 6 / 72 |
Outcome results
Primary
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
Time frame: 26 weeks
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Glucose Montoring | Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events | 13 participants |
| Standard Glucose Monitoring With a Home Glucose Meter | Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events | 19 participants |
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.
Time frame: 26 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Montoring | Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL) | 1.5 percentage of sensor readings |
| Standard Glucose Monitoring With a Home Glucose Meter | Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL) | 2.1 percentage of sensor readings |
Secondary
CGM Glucose Values (mg/dL)
Percentage of sensors values in range (71 mg/dL to 180 mg/dL)
Time frame: 26 weeks
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Montoring | CGM Glucose Values (mg/dL) | 48 percentage of sensor readings |
| Standard Glucose Monitoring With a Home Glucose Meter | CGM Glucose Values (mg/dL) | 49 percentage of sensor readings |
Secondary
Measures of Variability: Mean Absolute Rate of Change
mean absolute rate of change
Time frame: 26 weeks
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Montoring | Measures of Variability: Mean Absolute Rate of Change | 0.91 mg/dL per minute |
| Standard Glucose Monitoring With a Home Glucose Meter | Measures of Variability: Mean Absolute Rate of Change | 0.90 mg/dL per minute |
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
Time frame: 26 weeks
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Montoring | Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE) | 144 percentage of median |
| Standard Glucose Monitoring With a Home Glucose Meter | Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE) | 145 percentage of median |
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.
Time frame: 26 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Montoring | Measures of Variability: Standard Deviation (SD) | 73 mg/dL |
| Standard Glucose Monitoring With a Home Glucose Meter | Measures of Variability: Standard Deviation (SD) | 81 mg/dL |
Secondary
Number of Severe Hypoglycemic Events Experienced by Participants
Time frame: 26 weeks
Population: Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Glucose Montoring | Number of Severe Hypoglycemic Events Experienced by Participants | 3 events |
| Standard Glucose Monitoring With a Home Glucose Meter | Number of Severe Hypoglycemic Events Experienced by Participants | 6 events |
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.
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Montoring | Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale | 2.7 units on a scale | Standard Deviation 0.5 |
| Standard Glucose Monitoring With a Home Glucose Meter | Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale | 2.4 units on a scale | Standard Deviation 0.5 |
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
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Montoring | Parental Quality of Life Measures: CGM Satisfaction Scale | 3.9 units on a scale | Standard Deviation 0.5 |
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.
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Montoring | Parental Quality of Life Measures: Hypoglycemia Fear Survey | 38 units on a scale | Standard Deviation 17 |
| Standard Glucose Monitoring With a Home Glucose Meter | Parental Quality of Life Measures: Hypoglycemia Fear Survey | 42 units on a scale | Standard Deviation 19 |
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.
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Montoring | Parental Quality of Life Measures: PAID (Problem Areas in Diabetes) | 44 units on a scale | Standard Deviation 17 |
| Standard Glucose Monitoring With a Home Glucose Meter | Parental Quality of Life Measures: PAID (Problem Areas in Diabetes) | 49 units on a scale | Standard Deviation 16 |