Type 1 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.
Detailed description
Synopsis of study protocol This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on CGM (the intervention group) versus those who are not (the control group). The investigators will examine group differences over a 6-month period (Phase 1) on two sets of outcomes: psychosocial variables and glycemic variables. After the initial comparison of intervention to control across the first six months after diagnosis, the investigators will conduct a longitudinal follow-up (Phase 2) of glycemic and psychosocial variables for an additional 18 months. The CGM system used in this study is the Dexcom G5 System with the Share function (FDA Approved). An IDE was obtained to use this system in a non-adjunctive manner. Participants will complete Phase 1 in six months. Phase 2 includes 3 more assessments conducted every six months until participants are two years post-diagnosis. Study Procedures Participants will be recruited at two centers: Stanford University and the Barbara Davis Center for Diabetes, University of Colorado. Participants will be enrolled while inpatient or within 1 month of diagnosis. Once identified, study staff will approach potential participants to explain the study, determine eligibility, and obtain informed consent. Once enrolled in the study, participants will be randomized. Participants will be randomized at a 2:1 ratio, intervention to control. The investigators will also stratify by age group to ensure equal representation of ages across groups. The age groups (in years) are 2-6, 7-11, and 12-17. To ensure safety in the youngest group, recruitment of participants in the age 2-6 years group will not begin until the investigators have at least 2 weeks of non-adjunctive CGM use data in at least 3 participants aged 7-17 years. Data will be reviewed by the DSMB on these 3 participants and if deemed safe by the DSMB, the investigators will start enrolling participants in the youngest age group.
Interventions
DEVICECGM at diagnosis of T1D
Initiation of non-adjunctive CGM use at diagnosis of T1D
Sponsors
University of Colorado, Denver
Korey Hood
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for the study, a child must meet the following criteria: 1. Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria 2. Time since diagnosis of no longer than one month 3. Age between 2 and 17 years 4. Parental consent (and assent from the child where applicable) to participate in the study 5. No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial. To be eligible for the study, a parent must meet the following criteria: 1. Parent or legal guardian of a child with type 1 diabetes meeting the child criteria outlined above 2. Age of 18.0 years or older 3. Parent comprehends written English 4. Parent understands the study protocol and signs the informed consent document
Exclusion criteria
The presence of any of the following is an exclusion for the study: 1. Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application). 2. Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol 3. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study 4. Child is unable to completely avoid acetaminophen for duration of study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent in Blood Glucose Range (70-180mg/dL) | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point | Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point. |
| Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Baseline, 24 months | The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction. |
| Time Spent in Hypoglycemia (< 70 mg/dL) | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point | Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire 9 | Baseline, 24 months | This is a widely used measure that captures depressive symptoms, and was used to assess health symptoms in parents. Score range: 0-24. Higher scores indicate greater severity of symptoms. |
| State-Trait Anxiety Inventory | Baseline, 24 months | This is a widely used measure of anxiety symptoms, and was used to assess anxiety symptoms in parents. Score range for both state-anxiety is: 20-80. Higher scores indicate greater anxiety. |
| Pittsburgh Sleep Quality Index | Baseline, 24 months | This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants, and was used to assess sleep quality in parents. Score range is: 0-21. Higher scores indicate lower sleep quality. |
| Hypoglycemic Fear Survey | Baseline, 24 months | People with diabetes worry about hypoglycemia, and was used to assess parent's worry about their child. This measure captures those worries. Score range: 0-72. Higher scores indicate greater fear and worry of hypoglycemia. |
| Hypoglycemic Confidence Questionnaire | Baseline, 24 months | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations, and was used to assess parent's confidence. Score range: 8-32. Higher scores indicate greater confidence to manage hypoglycemia. |
| Pediatric Quality of Life Inventory | Baseline, 24 months | This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. Scores range from 0 to 100. Higher scores indicate greater quality of life. |
| Center for Epidemiologic Studies Depression Measure | Baseline, 24 months | This is a widely used measure of depression, and was used to assess depression symptoms in youths. Score range: 0-60. Higher scores indicate greater symptoms. |
| Child Health Utility 9D | Baseline, 24 months | Widely used measure of quality of life that is used to generate quality-adjusted life years, and was used to assess health symptoms in youth. Each score scale is 0 to 4, with scores of 3 or 4 denoting more severe problems. The count of participants responding 3 or higher for each parameter are presented. |
| Hemoglobin A1c | Baseline, 24 months | The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of control of diabetes. Collected through a blood sample. |
| C-peptide | Baseline, 24 months | This is a biologic measure of endogenous production and is collected through a blood sample. |
| General and Diabetes-specific Technology Use | Baseline, 24 months | This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. Score range: 5-25. Higher scores indicate more positive attitudes about technology. |
| Problem Areas in Diabetes Score | Baseline, 24 months | Participants in the study report on daily problems with diabetes via this measure. Respondents indicate the degree to which each of the items is currently a problem for them. Score range: 0 to 4, higher scores correspond to more serious problems. |
| Diabetes Distress Scale | Baseline, 24 months | This measure is widely used to capture the psychological distress experienced in relation to diabetes. Parent scale score range: 0-4. Youth scale score range: 1-6. Higher scores indicate greater diabetes-related distress. |
Countries
United States
Participant flow
Recruitment details
Both youth and parent were enrolled; parents were enrolled for assessments of surveys only, youth under 11 years of age did not complete surveys.
Participants by arm
| Arm | Count |
|---|---|
| CGM at Diagnosis of T1D Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months.
CGM at diagnosis of T1D: Initiation of non-adjunctive CGM use at diagnosis of T1D
Both groups followed through for up to 24 months | 42 |
| Usual Care Participants receive usual care for T1D for 6 months post diagnosis.
Both groups followed through for up to 24 months | 18 |
| Total | 60 |
Baseline characteristics
| Characteristic | Usual Care | Total | CGM at Diagnosis of T1D |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 60 Participants | 42 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 | 10.30 years STANDARD_DEVIATION 3.51 | 10.95 years STANDARD_DEVIATION 3.56 | 11.23 years STANDARD_DEVIATION 3.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 54 Participants | 38 Participants |
| Region of Enrollment United States | 18 Participants | 60 Participants | 42 Participants |
| Sex: Female, Male Female | 4 Participants | 28 Participants | 24 Participants |
| Sex: Female, Male Male | 14 Participants | 32 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 18 |
| other Total, other adverse events | 0 / 42 | 0 / 18 |
| serious Total, serious adverse events | 0 / 42 | 0 / 18 |
Outcome results
Primary
Glucose Monitoring Satisfaction Survey (GMSS) - Parent
The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction.
Time frame: Baseline, 24 months
Population: Participants with complete data (by youth and parent) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Parent - 24 months | 3.91 score on a scale | Standard Deviation 0.66 |
| CGM at Diagnosis of T1D | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Youth - baseline | 3.52 score on a scale | Standard Deviation 0.5 |
| CGM at Diagnosis of T1D | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Youth - 24 months | 3.76 score on a scale | Standard Deviation 0.6 |
| CGM at Diagnosis of T1D | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Parent - baseline | 3.65 score on a scale | Standard Deviation 0.59 |
| Usual Care | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Parent - baseline | 3.28 score on a scale | Standard Deviation 0.68 |
| Usual Care | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Parent - 24 months | 3.75 score on a scale | Standard Deviation 0.77 |
| Usual Care | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Youth - 24 months | 3.82 score on a scale | Standard Deviation 0.54 |
| Usual Care | Glucose Monitoring Satisfaction Survey (GMSS) - Parent | Youth - baseline | 3.54 score on a scale | Standard Deviation 0.27 |
p-value: 0.013Regression, Linear
Primary
Time Spent in Blood Glucose Range (70-180mg/dL)
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point.
Time frame: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
Population: This outcome was assessed in youths only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM at Diagnosis of T1D | Time Spent in Blood Glucose Range (70-180mg/dL) | 64.99 percentage of time | Standard Deviation 18.39 |
| Usual Care | Time Spent in Blood Glucose Range (70-180mg/dL) | 62.54 percentage of time | Standard Deviation 19.1 |
p-value: 0.64Regression, Linear
Primary
Time Spent in Hypoglycemia (< 70 mg/dL)
Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point.
Time frame: Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
Population: This outcome was assessed in youths only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM at Diagnosis of T1D | Time Spent in Hypoglycemia (< 70 mg/dL) | 1.87 percentage of time | Standard Deviation 1.65 |
| Usual Care | Time Spent in Hypoglycemia (< 70 mg/dL) | 5.06 percentage of time | Standard Deviation 5.13 |
p-value: 0.003Regression, Linear
Secondary
Center for Epidemiologic Studies Depression Measure
This is a widely used measure of depression, and was used to assess depression symptoms in youths. Score range: 0-60. Higher scores indicate greater symptoms.
Time frame: Baseline, 24 months
Population: Youth participants with complete data are included in the analysis. Parents did not complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Center for Epidemiologic Studies Depression Measure | Youth - baseline | 15.35 score on a scale | Standard Deviation 10.28 |
| CGM at Diagnosis of T1D | Center for Epidemiologic Studies Depression Measure | Youth - 24 months | 13.76 score on a scale | Standard Deviation 12.44 |
| Usual Care | Center for Epidemiologic Studies Depression Measure | Youth - baseline | 9.57 score on a scale | Standard Deviation 5.91 |
| Usual Care | Center for Epidemiologic Studies Depression Measure | Youth - 24 months | 10.64 score on a scale | Standard Deviation 7.44 |
Secondary
Child Health Utility 9D
Widely used measure of quality of life that is used to generate quality-adjusted life years, and was used to assess health symptoms in youth. Each score scale is 0 to 4, with scores of 3 or 4 denoting more severe problems. The count of participants responding 3 or higher for each parameter are presented.
Time frame: Baseline, 24 months
Population: Youth participants with complete data are included in the analysis. Parents did not complete this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months tired | 3 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months worried | 0 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline annoyed | 2 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months pain | 1 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months annoyed | 1 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline sad | 2 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline schoolwork | 2 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months routine | 0 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline sleep | 1 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months sad | 1 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months sleep | 0 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline tired | 4 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline routine | 0 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline pain | 0 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline activities | 1 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - baseline worried | 2 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months activities | 1 Participants |
| CGM at Diagnosis of T1D | Child Health Utility 9D | Youth - 24 months schoolwork | 1 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months activities | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline schoolwork | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months pain | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline worried | 1 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months worried | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline sad | 1 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months sad | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline pain | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline tired | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months tired | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline annoyed | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months annoyed | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months schoolwork | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline sleep | 1 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months sleep | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - 24 months routine | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline activities | 0 Participants |
| Usual Care | Child Health Utility 9D | Youth - baseline routine | 0 Participants |
Secondary
C-peptide
This is a biologic measure of endogenous production and is collected through a blood sample.
Time frame: Baseline, 24 months
Population: Youth participants with complete data are included in the analysis. Parent data was not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | C-peptide | Youth - baseline | 0.66 ng/mL | Standard Deviation 0.43 |
| CGM at Diagnosis of T1D | C-peptide | Youth - 24 months | 0.14 ng/mL | Standard Deviation 0.22 |
| Usual Care | C-peptide | Youth - baseline | 0.55 ng/mL | Standard Deviation 0.29 |
| Usual Care | C-peptide | Youth - 24 months | 0.15 ng/mL | Standard Deviation 0.17 |
Secondary
Diabetes Distress Scale
This measure is widely used to capture the psychological distress experienced in relation to diabetes. Parent scale score range: 0-4. Youth scale score range: 1-6. Higher scores indicate greater diabetes-related distress.
Time frame: Baseline, 24 months
Population: Participants with complete data (by youth and parent) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Diabetes Distress Scale | Parent - baseline | 1.19 score on a scale | Standard Deviation 0.7 |
| CGM at Diagnosis of T1D | Diabetes Distress Scale | Youth - baseline | 1.87 score on a scale | Standard Deviation 0.65 |
| CGM at Diagnosis of T1D | Diabetes Distress Scale | Parent - 24 months | 1.32 score on a scale | Standard Deviation 0.96 |
| CGM at Diagnosis of T1D | Diabetes Distress Scale | Youth - 24 months | 1.85 score on a scale | Standard Deviation 0.83 |
| Usual Care | Diabetes Distress Scale | Parent - 24 months | 1.32 score on a scale | Standard Deviation 1.05 |
| Usual Care | Diabetes Distress Scale | Youth - 24 months | 1.52 score on a scale | Standard Deviation 0.46 |
| Usual Care | Diabetes Distress Scale | Youth - baseline | 1.85 score on a scale | Standard Deviation 0.67 |
| Usual Care | Diabetes Distress Scale | Parent - baseline | 1.3 score on a scale | Standard Deviation 0.6 |
Secondary
General and Diabetes-specific Technology Use
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. Score range: 5-25. Higher scores indicate more positive attitudes about technology.
Time frame: Baseline, 24 months
Population: Participants with complete data (by youth and parent) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | General and Diabetes-specific Technology Use | Parent - baseline | 21.19 score on a scale | Standard Deviation 3.04 |
| CGM at Diagnosis of T1D | General and Diabetes-specific Technology Use | Youth - baseline | 21 score on a scale | Standard Deviation 2.4 |
| CGM at Diagnosis of T1D | General and Diabetes-specific Technology Use | Parent - 24 months | 21.19 score on a scale | Standard Deviation 3.8 |
| CGM at Diagnosis of T1D | General and Diabetes-specific Technology Use | Youth - 24 months | 21.59 score on a scale | Standard Deviation 2.7 |
| Usual Care | General and Diabetes-specific Technology Use | Parent - baseline | 20 score on a scale | Standard Deviation 3.19 |
| Usual Care | General and Diabetes-specific Technology Use | Youth - 24 months | 21 score on a scale | Standard Deviation 5.66 |
| Usual Care | General and Diabetes-specific Technology Use | Parent - 24 months | 21.92 score on a scale | Standard Deviation 2.87 |
| Usual Care | General and Diabetes-specific Technology Use | Youth - baseline | 19.71 score on a scale | Standard Deviation 4.03 |
Secondary
Hemoglobin A1c
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of control of diabetes. Collected through a blood sample.
Time frame: Baseline, 24 months
Population: Youth participants with complete data are included in the analysis. Parents are not included in this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Hemoglobin A1c | Youth - baseline | 10.61 mg/dL | Standard Deviation 2.02 |
| CGM at Diagnosis of T1D | Hemoglobin A1c | Youth - 24 months | 8.17 mg/dL | Standard Deviation 1.77 |
| Usual Care | Hemoglobin A1c | Youth - baseline | 10.64 mg/dL | Standard Deviation 2.5 |
| Usual Care | Hemoglobin A1c | Youth - 24 months | 7.5 mg/dL | Standard Deviation 1.54 |
Secondary
Hypoglycemic Confidence Questionnaire
Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations, and was used to assess parent's confidence. Score range: 8-32. Higher scores indicate greater confidence to manage hypoglycemia.
Time frame: Baseline, 24 months
Population: Participants with complete data (by youth and parent) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Hypoglycemic Confidence Questionnaire | Parent - 24 months | 24.9 score on a scale | Standard Deviation 4.32 |
| CGM at Diagnosis of T1D | Hypoglycemic Confidence Questionnaire | Youth - 24 months | 26.92 score on a scale | Standard Deviation 4.43 |
| CGM at Diagnosis of T1D | Hypoglycemic Confidence Questionnaire | Youth - baseline | 23.65 score on a scale | Standard Deviation 4.93 |
| CGM at Diagnosis of T1D | Hypoglycemic Confidence Questionnaire | Parent - baseline | 19.46 score on a scale | Standard Deviation 5.93 |
| Usual Care | Hypoglycemic Confidence Questionnaire | Parent - 24 months | 23.25 score on a scale | Standard Deviation 5.31 |
| Usual Care | Hypoglycemic Confidence Questionnaire | Parent - baseline | 16.11 score on a scale | Standard Deviation 6.21 |
| Usual Care | Hypoglycemic Confidence Questionnaire | Youth - baseline | 21.18 score on a scale | Standard Deviation 5.55 |
| Usual Care | Hypoglycemic Confidence Questionnaire | Youth - 24 months | 27.67 score on a scale | Standard Deviation 8.81 |
Secondary
Hypoglycemic Fear Survey
People with diabetes worry about hypoglycemia, and was used to assess parent's worry about their child. This measure captures those worries. Score range: 0-72. Higher scores indicate greater fear and worry of hypoglycemia.
Time frame: Baseline, 24 months
Population: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Hypoglycemic Fear Survey | Parent - 24 months | 21.45 score on a scale | Standard Deviation 15.42 |
| CGM at Diagnosis of T1D | Hypoglycemic Fear Survey | Parent - baseline | 23.67 score on a scale | Standard Deviation 12.56 |
| Usual Care | Hypoglycemic Fear Survey | Parent - baseline | 23.86 score on a scale | Standard Deviation 16.04 |
| Usual Care | Hypoglycemic Fear Survey | Parent - 24 months | 19.62 score on a scale | Standard Deviation 14.5 |
Secondary
Patient Health Questionnaire 9
This is a widely used measure that captures depressive symptoms, and was used to assess health symptoms in parents. Score range: 0-24. Higher scores indicate greater severity of symptoms.
Time frame: Baseline, 24 months
Population: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Patient Health Questionnaire 9 | Parent - baseline | 6.22 score on a scale | Standard Deviation 5.52 |
| CGM at Diagnosis of T1D | Patient Health Questionnaire 9 | Parent - month 24 | 4.53 score on a scale | Standard Deviation 4.53 |
| Usual Care | Patient Health Questionnaire 9 | Parent - baseline | 9.22 score on a scale | Standard Deviation 7.41 |
| Usual Care | Patient Health Questionnaire 9 | Parent - month 24 | 3.71 score on a scale | Standard Deviation 5.06 |
Secondary
Pediatric Quality of Life Inventory
This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. Scores range from 0 to 100. Higher scores indicate greater quality of life.
Time frame: Baseline, 24 months
Population: Participants with complete data (by youth and parent) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Pediatric Quality of Life Inventory | Youth - baseline | 75.38 score on a scale | Standard Deviation 13.48 |
| CGM at Diagnosis of T1D | Pediatric Quality of Life Inventory | Youth - 24 months | 82.67 score on a scale | Standard Deviation 14.49 |
| CGM at Diagnosis of T1D | Pediatric Quality of Life Inventory | Parent - baseline | 75.27 score on a scale | Standard Deviation 14.79 |
| CGM at Diagnosis of T1D | Pediatric Quality of Life Inventory | Parent - 24 months | 81.23 score on a scale | Standard Deviation 18.89 |
| Usual Care | Pediatric Quality of Life Inventory | Parent - 24 months | 87.89 score on a scale | Standard Deviation 11.62 |
| Usual Care | Pediatric Quality of Life Inventory | Youth - baseline | 85.23 score on a scale | Standard Deviation 8.25 |
| Usual Care | Pediatric Quality of Life Inventory | Parent - baseline | 81.05 score on a scale | Standard Deviation 12.26 |
| Usual Care | Pediatric Quality of Life Inventory | Youth - 24 months | 92.08 score on a scale | Standard Deviation 10.31 |
Secondary
Pittsburgh Sleep Quality Index
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants, and was used to assess sleep quality in parents. Score range is: 0-21. Higher scores indicate lower sleep quality.
Time frame: Baseline, 24 months
Population: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Pittsburgh Sleep Quality Index | Parent - baseline | 7.04 score on a scale | Standard Deviation 3.03 |
| CGM at Diagnosis of T1D | Pittsburgh Sleep Quality Index | Parent - 24 months | 6.1 score on a scale | Standard Deviation 3.06 |
| Usual Care | Pittsburgh Sleep Quality Index | Parent - baseline | 7.57 score on a scale | Standard Deviation 3.9 |
| Usual Care | Pittsburgh Sleep Quality Index | Parent - 24 months | 5.56 score on a scale | Standard Deviation 2.96 |
Secondary
Problem Areas in Diabetes Score
Participants in the study report on daily problems with diabetes via this measure. Respondents indicate the degree to which each of the items is currently a problem for them. Score range: 0 to 4, higher scores correspond to more serious problems.
Time frame: Baseline, 24 months
Population: Participants with complete data (by youth and parent) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | Problem Areas in Diabetes Score | Parent - baseline | 1.84 score on a scale | Standard Deviation 0.73 |
| CGM at Diagnosis of T1D | Problem Areas in Diabetes Score | Youth - baseline | 1.02 score on a scale | Standard Deviation 0.72 |
| CGM at Diagnosis of T1D | Problem Areas in Diabetes Score | Youth - 24 months | 0.77 score on a scale | Standard Deviation 0.81 |
| CGM at Diagnosis of T1D | Problem Areas in Diabetes Score | Parent - 24 months | 1.68 score on a scale | Standard Deviation 0.75 |
| Usual Care | Problem Areas in Diabetes Score | Parent - 24 months | 1.74 score on a scale | Standard Deviation 0.79 |
| Usual Care | Problem Areas in Diabetes Score | Parent - baseline | 2.11 score on a scale | Standard Deviation 0.75 |
| Usual Care | Problem Areas in Diabetes Score | Youth - 24 months | 0.43 score on a scale | Standard Deviation 0.44 |
| Usual Care | Problem Areas in Diabetes Score | Youth - baseline | 0.78 score on a scale | Standard Deviation 0.48 |
Secondary
State-Trait Anxiety Inventory
This is a widely used measure of anxiety symptoms, and was used to assess anxiety symptoms in parents. Score range for both state-anxiety is: 20-80. Higher scores indicate greater anxiety.
Time frame: Baseline, 24 months
Population: Parent participants with complete data are included in the analysis. Youth did not complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM at Diagnosis of T1D | State-Trait Anxiety Inventory | Parent - baseline state-anxiety | 44.34 score on a scale | Standard Deviation 11.84 |
| CGM at Diagnosis of T1D | State-Trait Anxiety Inventory | Parent - 24 months state-anxiety | 39.39 score on a scale | Standard Deviation 14.87 |
| Usual Care | State-Trait Anxiety Inventory | Parent - baseline state-anxiety | 49.71 score on a scale | Standard Deviation 17 |
| Usual Care | State-Trait Anxiety Inventory | Parent - 24 months state-anxiety | 34.05 score on a scale | Standard Deviation 11.56 |