Introducing CGM at Type 1 Diabetes Diagnosis

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03736083
• Other study ID #: IRB201802031 -A
• Secondary ID: OCR19017
• Status: Withdrawn
• Phase: N/A
• Start date: September 2019
• Est. completion date: October 2020

Study information

• Verified date: November 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis of type 1 diabetes mellitus

Exclusion Criteria:

• No diagnosis of type 1 diabetes mellitus

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type1diabetes

Intervention

Device:
• Freestyle 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Diabetes Action Research and Education Foundation

References & Publications (8)

Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr. 2010 Jul 15;10:50. doi: 10.1186/1471-2431-10-50. Review. — View Citation

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12. — View Citation

Gonder-Frederick L, Nyer M, Shepard JA, Vajda K, Clarke W. Assessing fear of hypoglycemia in children with Type 1 diabetes and their parents. Diabetes Manag (Lond). 2011;1(6):627-639. — View Citation

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. Diabetes Care. 2010 Jan;33(1):17-22. doi: 10.2337/dc09-1502. Epub 2009 Oct 16. — View Citation

Markowitz JT, Volkening LK, Butler DA, Laffel LM. Youth-Perceived Burden of Type 1 Diabetes: Problem Areas in Diabetes Survey-Pediatric Version (PAID-Peds). J Diabetes Sci Technol. 2015 Apr 24;9(5):1080-5. doi: 10.1177/1932296815583506. — View Citation

Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. — View Citation

Shapiro JB, Vesco AT, Weil LEG, Evans MA, Hood KK, Weissberg-Benchell J. Psychometric Properties of the Problem Areas in Diabetes: Teen and Parent of Teen Versions. J Pediatr Psychol. 2018 Jun 1;43(5):561-571. doi: 10.1093/jpepsy/jsx146. — View Citation

Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of flash glucose measurements at the intervention arm	# of flash measurements provided by the freestyle reader	3 months
Other	Number of glucose measurements of the control arm	# of glucose readers based on there glucose meter download	3 months
Other	Percentage of glucose sensor readings within the range of 70 to 180 mg/dl	Data by Freestyle libre readings	3 months
Other	Percentage of glucose sensor readings below 80 mg/dl	Data by Freestyle libre readings	3 months
Other	Percentage of glucose sensor readings above 180 mg/dl	Data by Freestyle libre readings	3 months
Primary	Change in Diabetes Treatment Satisfaction Questionnaire- Parent version	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'	2 weeks,3 months, and 12 months
Secondary	Change in Diabetes Treatment Satisfaction Questionnaire- Teen version	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	2 weeks,3 months, and 12 months
Secondary	Change in Pediatric Quality of Life Survey- Parent and child versions	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'	2 weeks,3 months, and 12 months
Secondary	Change in Problem Areas in Diabetes survey	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.'	2 weeks,3 months, and 12 months
Secondary	Change in Hypoglycemia Fear Survey - Parent and Child Versions	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'	2 weeks,3 months, and 12 months
Secondary	Change in Diabetes Distress Survey- Parent version	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.'	2 weeks,3 months, and 12 months
Secondary	Change in Glycemic control measured by A1c	Measurement of A1c	3 and 12 months