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Introducing CGM at Type 1 Diabetes Diagnosis

Introducing Continuous Glucose Monitoring Technology at Diagnosis in Pediatric Type 1 Diabetes: A Proof of Concept Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03736083
Enrollment
0
Registered
2018-11-08
Start date
2019-09-30
Completion date
2020-10-31
Last updated
2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia, Type1diabetes

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

DEVICEFreestyle Libre Blood Glucose Monitor

The intervention arm of this study will begin using the Freestyle Libre glucose monitor within 2 weeks of their diabetes diagnosis

Sponsors

Diabetes Action Research and Education Foundation
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Diagnosis of type 1 diabetes mellitus

Exclusion criteria

* No diagnosis of type 1 diabetes mellitus

Design outcomes

Primary

MeasureTime frameDescription
Change in Diabetes Treatment Satisfaction Questionnaire- Parent version2 weeks,3 months, and 12 monthsSurvey 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

MeasureTime frameDescription
Change in Pediatric Quality of Life Survey- Parent and child versions2 weeks,3 months, and 12 monthsSurvey 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 version2 weeks,3 months, and 12 monthsSurvey 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 survey2 weeks,3 months, and 12 monthsSurvey 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 Versions2 weeks,3 months, and 12 monthsSurvey 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 version2 weeks,3 months, and 12 monthsThe 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 A1c3 and 12 monthsMeasurement of A1c

Other

MeasureTime frameDescription
Percentage of glucose sensor readings within the range of 70 to 180 mg/dl3 monthsData by Freestyle libre readings
Percentage of glucose sensor readings below 80 mg/dl3 monthsData by Freestyle libre readings
Percentage of glucose sensor readings above 180 mg/dl3 monthsData by Freestyle libre readings
Number of glucose measurements of the control arm3 months\# of glucose readers based on there glucose meter download
Number of flash glucose measurements at the intervention arm3 months\# of flash measurements provided by the freestyle reader

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026