High Risk Youth With Poorly-controlled Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Group Education Program for High-risk Youth With Poorly-controlled Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680079
• Other study ID #: 201807091
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

It has been well established through The Diabetes Control and Complications Trial (DCCT) and its follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) studies that achieving lower hemoglobin A1c (HbA1c) levels are associated with the delay and prevention of long-term complications of T1DM (1, 2). Management of T1DM involves adherence to a complex, labor-intensive regimen of subcutaneous insulin treatment, close glucose monitoring, accurate calculation of carbohydrate intake, and adjustment of dosing and dietary regimen to account for physical activity.

Recent technological advances including insulin pumps with auto-insulin-adjusting features along with continuous glucose monitoring systems have allowed for individuals with T1DM to achieve tighter diabetes control. However, despite these advances in glucose monitoring and insulin delivery systems, the majority of children and adolescents fail to optimize their diabetes control and are unable to achieve these targets.

Several studies have shown that adolescents in poor diabetes control are more likely to come from a racial minority background, have lower annual household income, and be publicly insured. In addition, these patients are also more likely to have missed medical appointments and have less stable home environments. Thus, increased efforts and innovative programs are needed to overcome additional barriers faced by youth with T1DM from disadvantaged backgrounds with the goal of improving the delivery of diabetes care for our most vulnerable, at-risk youth population.

The objective of this pilot and feasibility project is to implement a clinic-based group education program targeting teens with poorly controlled diabetes, focusing on peer group interaction and education combined with social media support to increase engagement and promote behavioral change to improve glycemic control.

This study utilizes 1) group education sessions (6 total sessions over the course of 9 months), 2) online social media group forums, 3) questionnaires to assess self-care habits in diabetes management and quality of life, and 4) surveys to assess this program.

Patients will be included in closed, private Facebook, Snapchat, and Instagram groups where members can communicate with each other and where biweekly updates, reminders, and messages of encouragement relevant to the previous topic covered at group sessions can be sent to the group. Online group forums will be moderated by a staff member to ensure that message content is appropriate and to avoid misinformation or questionable patient-to-patient medical advice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Between ages 13-18 (at the time of consent) with diagnosis of T1DM

2. HbA1c >9% and/or episode of DKA within the past year (other than at diagnosis)

3. Residence in a zip code associated with lower socioeconomic status (SES)

4. Possession of a device capable of accessing online social media platforms

Exclusion criteria:

1. Non-English speaking

2. Diagnosed with a developmental or psychological condition that would prevent assumption of self-care responsibilities

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Measure of glycemic control	12 months
Secondary	Diabetes self-management skills	Questionnaire (Self-Care Inventory--Revised Edition) to assess self-management skills prior to and after participation in this study.; The questionnaire is a validated measure of perceptions of adherence to recommended diabetes self-care behaviors. There are a total of 15 questions, each with a number answer from a scale of "1" to "5". The lowest possible total score is 15, representing poor compliance with diabetes self-management skills, and the highest possible total score would be 75.	9 months
Secondary	Improved quality of life	Peds QL Diabetes Module Version 3.0, Teen Report. This is a validated questionnaire to assess quality of life related to diabetes, this will be filled out at the start and after participation in this study. The questionnaire consists of 28 questions with answers from a scale of "0" to "4" with higher scores representing lower quality of life.	9 months
Secondary	Number of hospital admissions for DKA	Measure of severe diabetes episodes	12 months
Secondary	Depression screening	The PHQ-2 depression questionnaire is a validated 2 question screen for depression.; Each question has an answer scale from "0" to "3". A score of 3 or more (highest score would be 6) is a positive screen for depression.; This questionnaire will be given to participants at the start and after participation in this study.	9 months