High Risk Youth With Poorly-controlled Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Group education sessions

• Registration Number: NCT03680079
• Lead Sponsor: Washington University School of Medicine

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.

Detailed 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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HbA1c	12 months	Measure of glycemic control

Secondary Outcome Measures

Name	Time	Method
Depression screening	9 months	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.
Number of hospital admissions for DKA	12 months	Measure of severe diabetes episodes
Diabetes self-management skills	9 months	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.
Improved quality of life	9 months	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.

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States