High Risk Youth With Poorly-controlled Diabetes

NCT03680079 | Completed DMC

• 1 other identifier: 201807091
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to implement a group education curriculum integrated with social media participation to provide peer support and interactive education sessions with the goal of improving glycemic control in disadvantaged youth with poorly-controlled type 1 diabetes.

Conditions

Type 1 Diabetes Mellitus

Keywords

social media; noncompliance; youth; group education

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Measure of glycemic control

  12 months

Secondary Outcomes (4)

• Diabetes self-management skills

  9 months

• Improved quality of life

  9 months

• Number of hospital admissions for DKA

  12 months

• Depression screening

  9 months

Study Arms (1)

Youth with type 1 diabetes

OTHER

A group of 16 teens (ages 13-18) with poorly -controlled type 1 diabetes will be recruited to participate in this study.

Other: Group education sessions

Interventions

Group education sessions OTHER

Peer support and interaction both in-person during group education sessions and online via social media platforms

Also known as: Social media peer support

Youth with type 1 diabetes

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between ages 13-18 (at the time of consent) with diagnosis of T1DM
• HbA1c \>9% and/or episode of DKA within the past year (other than at diagnosis)
• Residence in a zip code associated with lower socioeconomic status (SES)
• Possession of a device capable of accessing online social media platforms

You may not qualify if:

• Non-English speaking
• Diagnosed with a developmental or psychological condition that would prevent assumption of self-care responsibilities

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• DCCT/EDIC research group. Effect of intensive diabetes treatment on albuminuria in type 1 diabetes: long-term follow-up of the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications study. Lancet Diabetes Endocrinol. 2014 Oct;2(10):793-800. doi: 10.1016/S2213-8587(14)70155-X. Epub 2014 Jul 17.

  PMID: 25043685 BACKGROUND

• Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Intensive Diabetes Treatment and Cardiovascular Outcomes in Type 1 Diabetes: The DCCT/EDIC Study 30-Year Follow-up. Diabetes Care. 2016 May;39(5):686-93. doi: 10.2337/dc15-1990. Epub 2016 Feb 9.

  PMID: 26861924 BACKGROUND

• Campbell MS, Schatz DA, Chen V, Wong JC, Steck A, Tamborlane WV, Smith J, Beck RW, Cengiz E, Laffel LM, Miller KM, Haller MJ; T1D Exchange Clinic Network. A contrast between children and adolescents with excellent and poor control: the T1D Exchange clinic registry experience. Pediatr Diabetes. 2014 Mar;15(2):110-7. doi: 10.1111/pedi.12067. Epub 2013 Aug 19.

  PMID: 23957219 BACKGROUND

• Khanolkar AR, Amin R, Taylor-Robinson D, Viner RM, Warner JT, Stephenson T. Young people with Type 1 diabetes of non-white ethnicity and lower socio-economic status have poorer glycaemic control in England and Wales. Diabet Med. 2016 Nov;33(11):1508-1515. doi: 10.1111/dme.13079. Epub 2016 Feb 23.

  PMID: 26802317 BACKGROUND

• Fortin K, Pries E, Kwon S. Missed Medical Appointments and Disease Control in Children With Type 1 Diabetes. J Pediatr Health Care. 2016 Jul-Aug;30(4):381-9. doi: 10.1016/j.pedhc.2015.09.012. Epub 2015 Nov 7.

  PMID: 26559135 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Patient Compliance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ellen Kim, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention being studied is a group education program

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 21, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)