Type 1 Diabetes Mellitus
Conditions
Brief summary
The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
Interventions
Education and training related to use of CGM in this age group
Education and training on reducing distress
Education and training on the use of remote monitoring
Education and training on reducing fear of hypoglycemia
No intervention - serves as the control group
Sponsors
Study design
Eligibility
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 at least six months 3. Age between 2 and 6 years at enrollment 4. Parental consent 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. 6. If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment 7. Own and use an iPhone, or be willing/able to carry a study-supplied wi-fi enabled iPod 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 5. Parent has access to a personal computer to upload diabetes devices and send to research team 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 | Change over 6 months | 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. |
| Pediatric Quality of Life Inventory | Change over 6 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Scale | Change over 6 months | This measure is widely used to capture the psychological distress experienced in relation to diabetes. |
| Patient Health Questionnaire 9 | Change over 6 months | This is a widely used measure that captures depressive symptoms. It is reported by the participants. |
| State-Trait Anxiety Inventory | Change over 6 months | This is a widely used measure of anxiety symptoms. It is reported by the participant. |
| Pittsburgh Sleep Quality Index | Change over 6 months | This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants. |
| A1c | Change over 6 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. |
| Hypoglycemic Confidence Questionnaire | Change over 6 months | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations. |
| Glucose Monitoring System Satisfaction Survey | Change over 6 months | This a measure used to capture overall satisfaction with glucose monitoring devices used by participants. |
| General and diabetes-specific technology use | Change over 6 months | This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. |
| Hypoglycemic Fear Survey | Change over 6 months | People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants. |
| Problem Areas in Diabetes | Change over 6 months | This measure captures areas that are reported as problems for people with diabetes. Participants in the study report on daily problems with diabetes via this measure. |
Countries
United States