Introducing CGM at Type 1 Diabetes Diagnosis

NCT ID: NCT03736083

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-10-31

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).

Conditions

Type1diabetes; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Freestyle Libre Group

Freestyle Libre Group: Participants will use the Freestyle Libre flash glucose monitoring system throughout the study for 2-3 months.

Group Type: ACTIVE_COMPARATOR

Freestyle Libre Blood Glucose Monitor

Intervention Type: DEVICE

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

Control Group (standard diabetes care)

This group will receive standard care. At the around 1 week and 2 month visits, control group subjects will use a blinded Freestyle Libre Pro to provide data that can be used to compare glucose variability between groups. The Libre sensor will allow the study team to measure glucose values but the subjects will not have access to this information for management/treatment decisions and usual diabetes care will be unaffected. The Freestyle Libre Pro last 14 days, can be activated in clinic, and the sensor can be returned in person or via mail where the investigators will download the data.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of type 1 diabetes mellitus

Exclusion Criteria

• No diagnosis of type 1 diabetes mellitus

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diabetes Action Research and Education Foundation

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Hiers, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

References

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger 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.

Reference Type: BACKGROUND

PMID: 27634581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19837791 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29267939 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20633252 (View on PubMed)

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. doi: 10.2217/DMT.11.60.

Reference Type: BACKGROUND

PMID: 22180760 (View on PubMed)

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. doi: 10.2337/diacare.28.3.626.

Reference Type: BACKGROUND

PMID: 15735199 (View on PubMed)

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. doi: 10.2337/diacare.26.3.631.

Reference Type: BACKGROUND

PMID: 12610013 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25910541 (View on PubMed)

Other Identifiers

OCR19017

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201802031 -A

Identifier Type: -

Identifier Source: org_study_id