Introducing CGM at Type 1 Diabetes Diagnosis

NCT03736083 | Withdrawn FDA Device

• 2 other identifiers: IRB201802031 -AOCR19017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type1diabetes; Hypoglycemia

Keywords

glucose monitoring; glycemic control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Diabetes Treatment Satisfaction Questionnaire- Teen version

  2 weeks,3 months, and 12 months

• Change in Pediatric Quality of Life Survey- Parent and child versions

  2 weeks,3 months, and 12 months

• Change in Problem Areas in Diabetes survey

  2 weeks,3 months, and 12 months

• Change in Hypoglycemia Fear Survey - Parent and Child Versions

  2 weeks,3 months, and 12 months

• Change in Diabetes Distress Survey- Parent version

  2 weeks,3 months, and 12 months

Other Outcomes (5)

• Number of flash glucose measurements at the intervention arm

  3 months

• Number of glucose measurements of the control arm

  3 months

• Percentage of glucose sensor readings within the range of 70 to 180 mg/dl

  3 months

Study Arms (2)

Freestyle Libre Group

ACTIVE COMPARATOR

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

Device: Freestyle Libre Blood Glucose Monitor

Control Group (standard diabetes care)

NO INTERVENTION

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.

Interventions

Freestyle Libre Blood Glucose Monitor DEVICE

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

Freestyle Libre Group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of type 1 diabetes mellitus

You may not qualify if:

• No diagnosis of type 1 diabetes mellitus

Sponsors & Collaborators

• University of Florida: lead
• Diabetes Action Research and Education Foundation: collaborator

Related Publications (8)

• 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.

  PMID: 27634581 BACKGROUND

• 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.

  PMID: 19837791 BACKGROUND

• 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.

  PMID: 29267939 BACKGROUND

• 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.

  PMID: 20633252 BACKGROUND

• 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.

  PMID: 22180760 BACKGROUND

• 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.

  PMID: 15735199 BACKGROUND

• 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.

  PMID: 12610013 BACKGROUND

• 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.

  PMID: 25910541 BACKGROUND

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Paul Hiers, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: September 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 21, 2019

Record last verified: 2019-11