High Risk Youth With Poorly-controlled Diabetes

September 20, 2019 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Youth with type 1 diabetes
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
Peer support and interaction both in-person during group education sessions and online via social media platforms
Other Names:
  • Social media peer support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 12 months
Measure of glycemic control
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Ellen Kim, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201807091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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