Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: CGM at diagnosis of T1D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for the study, a child must meet the following criteria: Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria Time since diagnosis of no longer than one month Age between 2 and 17 years Parental consent (and assent from the child where applicable) to participate in the study 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: Parent or legal guardian of a child with type 1 diabetes meeting the child criteria outlined above Age of 18.0 years or older Parent comprehends written English 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: 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). Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study Child is unable to completely avoid acetaminophen for duration of study

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM at diagnosis of T1D<br>Participants start non-adjunctive use of CGM at diagnosis of T1D and continue for 6 months. | Device: CGM at diagnosis of T1D<br>* Initiation of non-adjunctive CGM use at diagnosis of T1D<br>|
| No Intervention: Usual Care<br>Participants receive usual care for T1D for 6 months post diagnosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point | 
| 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. | Baseline, 24 months | 
| Time Spent in Hypoglycemia (< 70 mg/dL) | Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point. | Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| 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. | Baseline, 24 months | 
| C-peptide | This is a biologic measure of endogenous production and is collected through a blood sample. | Baseline, 24 months |