Hypoglycemia, Type1diabetes
Conditions
Keywords
glucose monitoring, glycemic control
Brief summary
Diabetes technology is changing and has quickly become an integral part of diabetes care and management. The study team plans to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. The investigators hypothesize that early access to continuous glucose monitoring (CGM) technology will potentially improve satisfaction scores, hemoglobin A1c, glycemic control, reduce hypoglycemia, and ease the burden of disease when compared to new onset patients who receive standard of care access to CGM.
Detailed description
Abstract: Diabetes technology is changing and has quickly become an integral part of diabetes care and management. Typically, patients will need to wait months due to paperwork, insurance, and logistical issues before utilizing these technologies. With this project, the investigators plan to study the effects of introducing technology to newly diagnosed type 1 diabetes patients. It is hypothesized that early access to flash continuous glucose monitoring (CGM) technology will improve scores in diabetes's measures. The primary outcome with be the parent version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Secondary outcomes will include other diabetes measures such as DTSQ teen version, Hypoglycemia Fear Survey (HFS)- Parent and child version, Diabetes Distress Survey (DDS)-parent version, PedsQL- parent and child versions. The study team will also look at other diabetes outcomes including A1c, time in range, and reduction in hypoglycemia. Background: Type 1 diabetes is a complex disease requiring newly diagnosed pediatric patients and families to learn how to check blood glucoses, inject insulin, count carbohydrates, treat hypoglycemia/hyperglycemia, and perform many other complex tasks, all within the first few days after diagnosis. Continuous glucose monitors (CGMs) and flash glucose monitors have emerged as important diabetes technologies towards providing improved care and easing the burden of disease. These technologies are most typically introduced to families in the outpatient setting 2-3 months following diagnosis due to logistical issues related to insurance coverage. Barriers to access include requirements for insurance prior authorization, lack of immediate availability at local pharmacies, need for patient training, and the historical bias towards requiring finger stick glucose monitoring as the basis for diabetes management. Despite these barriers, the data supports the observation that CGM technology provides for better understanding of diabetes, improved quality of life for parents and children, reduced frequency of hypoglycemia, and improved A1c. This project will potentially show the feasibility of introducing these technologies at diagnosis. New onset type 1 diabetes patients will be randomized to receive either a Freestyle Libre flash glucose monitoring system immediately at diagnosis or to delayed use of CGM (standard of care).
Interventions
The intervention arm of this study will begin using the Freestyle Libre glucose monitor within 2 weeks of their diabetes diagnosis
Sponsors
Study design
Intervention model description
The study team will enroll 52 consecutive new onset type 1 diabetes patients and stratify the subjects into two groups, age 4-10 vs 11-17, aiming for 26 subjects in each group. Participants will be randomized to one of the two groups using blocked randomization with random block sizes of 2 and 4, stratified by age (4-10 vs. 11-17).
Eligibility
Inclusion criteria
* Diagnosis of type 1 diabetes mellitus
Exclusion criteria
* No diagnosis of type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Treatment Satisfaction Questionnaire- Parent version | 2 weeks,3 months, and 12 months | Survey for Diabetes treatment satisfaction: 14 question survey with each question scaled from 0-6; with 0 being 'very dissatisfied' and 4 being 'very satisfied' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Quality of Life Survey- Parent and child versions | 2 weeks,3 months, and 12 months | Survey for Pediatric quality of life: 33 question survey with each question scaled from 0-4; with 0 being 'never to 4 being 'almost always' |
| Change in Diabetes Treatment Satisfaction Questionnaire- Teen version | 2 weeks,3 months, and 12 months | Survey for Diabetes treatment satisfaction: 12 question survey with each question scaled from 0-6; with 0 being 'very dissatisfied' and 6 being 'very satisfied |
| Change in Problem Areas in Diabetes survey | 2 weeks,3 months, and 12 months | Survey for diabetes specific distress: mean item score or 0 - 1.9 should be considered little or no distress, a mean item score between 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score \> 3.0 should be considered 'high distress.' |
| Change in Hypoglycemia Fear Survey - Parent and Child Versions | 2 weeks,3 months, and 12 months | Survey for fear associated with hypoglycemia: 26 question survey with each question scaled from 0-4; with 0 being 'never' and 4 being 'almost always' |
| Change in Diabetes Distress Survey- Parent version | 2 weeks,3 months, and 12 months | The PARENT DDS yields a total diabetes distress score plus 4 subscale scores, each addressing a different kind of distress. To score, simply sum the patient's responses to the appropriate items and divide by the number of items in that scale. Current research suggests that a mean item score or 0 - 1.9 should be considered little or no distress, a mean item score between 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score \> 3.0 should be considered 'high distress.' |
| Change in Glycemic control measured by A1c | 3 and 12 months | Measurement of A1c |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of glucose sensor readings within the range of 70 to 180 mg/dl | 3 months | Data by Freestyle libre readings |
| Percentage of glucose sensor readings below 80 mg/dl | 3 months | Data by Freestyle libre readings |
| Percentage of glucose sensor readings above 180 mg/dl | 3 months | Data by Freestyle libre readings |
| Number of glucose measurements of the control arm | 3 months | \# of glucose readers based on there glucose meter download |
| Number of flash glucose measurements at the intervention arm | 3 months | \# of flash measurements provided by the freestyle reader |