Type 1 Diabetes Mellitus
Conditions
Keywords
670G, Hybrid closed-loop system, pediatric
Brief summary
This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
Interventions
BEHAVIORALDevelopmental & Technological Demands
Education and training related to use of CGM in this age group
BEHAVIORALDistress Reduction
Education and training on reducing distress
BEHAVIORALNutrition, Set Point, & C:I Ratio
Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control
BEHAVIORALHypoglycemia management
Education and training on reducing worries of hypoglycemia
BEHAVIORALMinimal Intervention
Minimal intervention to simulate standard care - serves as the control group
Sponsors
University of Colorado, Denver
Indiana University
Yale University
University of South Florida
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for the study, a child must meet the following criteria since enrollment in the CEP 302 Trial: 1. Diagnosis of type 1 diabetes according to ADA diagnostic criteria 2. Time since diagnosis of at least six months 3. Age between 2.00 and 6.99 years at enrollment 4. Parental consent to participate in the study 5. Completion of the CEP 302 Trial and in the continuation phase of the Medtronic CEP 302 Trial using the Medtronic MiniMed 670G pump with Enlite3 sensor. 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. The presence of any of the following is an exclusion for the study (since enrollment in the CEP 302 Trial): 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 3 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Problem Areas in Diabetes | Change over 3 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. |
| Parent Diabetes Distress Scale | Change over 3 months | This measure is widely used to capture the psychological distress experienced in relation to diabetes. |
| Patient Health Questionnaire 8 | Change over 3 months | This is a widely used measure that captures depressive symptoms. It is reported by the participants. |
| State-Trait Anxiety Inventory | Change over 3 months | This is a widely used measure of anxiety symptoms. It is reported by the participant. |
| Pittsburgh Sleep Quality Index | Change over 3 months | This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants. |
| Hypoglycemic Fear Survey - Parents | Change over 3 months | People with diabetes worry about hypoglycemia. This measure captures those worries and is reported by participants. |
| Hemoglobin A1c | Change over 3 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. |
| Pediatric Quality of Life Inventory | Change over 3 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. |
| Glucose Monitoring System Satisfaction Survey | Change over 3 months | This a measure used to capture overall satisfaction with glucose monitoring devices used by participants. |
| General and diabetes-specific technology use | Change over 3 months | This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. |
| Diabetes management behaviors | Change over 3 months | Amount of time spent in Auto Mode; blood glucose monitoring frequency (by meter download); adherence to pump boluses. It is objectively reported by device downloads. |
| Health care utilization | Change over 3 months | Number of visits and calls to the diabetes care team. |
| Hypoglycemia Confidence Questionnaire | Change over 3 months | Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations. |
Countries
United States
Outcome results
None listed