Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study

August 3, 2021 updated by: Lori Laffel, Joslin Diabetes Center
The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set of psychoeducational materials for teens with type 1 diabetes and (2) text message reminders to check blood glucose levels can help improve blood glucose levels in teens with type 1 diabetes.

Study Overview

Detailed Description

Glycemic control deteriorates during adolescence as parents become less involved in teens' diabetes management and adherence declines. Thus, there is a need to improve adherence and glycemic control in mid to older teens with type 1 diabetes by strengthening the teens' self-efficacy for daily diabetes self-management to help prepare them for the transition between pediatric and adult care. This 18-month, multi-center RCT is designed to increase frequency of blood glucose monitoring and improve glycemic control in teens with type 1 diabetes through a behavioral intervention called Teenwork with or without text message reminders to check blood glucose levels.

We will implement and evaluate the Teenwork intervention and text message reminders to check blood glucose levels in a 2x2 factorial design in which 300 participants, across two sites, will be randomized to 1 of 4 groups: Teenwork, Text Message, Teenwork/Text Message, or Usual Care.

Participants in the Teenwork Group will meet with a research assistant during each study visit to review strategies for improving self-care, including self-management and self-advocacy, focusing on two areas: blood glucose monitoring and insulin administration. Participants in the Text Message Group will be instructed in the use of the text messaging system. They will receive 2-way text message reminders to check blood glucose levels at self-selected times and to reply by text message with blood glucose results. Participants in the Teenwork/Text Message Group will receive both the Teenwork intervention and the text message reminders (as described above). Participants in the Usual Care Group will receive the same intervention as the Teenwork/Text Message Group, but not until after 1 year.

Study Type

Interventional

Enrollment (Actual)

310

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

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital/Baylor College of Medicine

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 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Youth age 13-17 years
  • Diagnosis of type 1 diabetes according to American Diabetes Association criteria
  • Diabetes duration ≥6 months
  • Daily insulin dose ≥0.5 units/kg
  • A1c ≥6.5%and ≤11%
  • Willingness to check blood glucose levels
  • Cell phone with text messaging ability
  • Clinic attendance

    1. At least one clinic visit at the clinical site in the previous 12 months
    2. Anticipated care at the clinical site for the duration of the study
  • Fluency in English (reading, writing, and speaking) for child and parent/guardian
  • Enrollment no later than December of the teen's senior year of high school

Exclusion Criteria:

  • Pregnancy in the youth participant
  • Significant developmental or cognitive disorder that would prevent full study participation
  • Significant mental illness, defined by either major psychiatric disorder (e.g., diagnosed eating disorder, major psychoses) or inpatient psychiatric admission within the previous 6 months
  • Failure to understand that the 2-way text messaging does NOT result in immediate response from a health care professional; this will be assessed at the time of informed consent/assent
  • Participation in another intervention study within the 3 months prior to enrollment
  • Other psychosocial, medical, or family issues, as assessed by the teen's pediatric team, that would prevent full study participation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teenwork Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
Experimental: Teenwork/Text Message Group
Teen/family will receive the Teenwork intervention at each quarterly study visit. Teen will receive text message reminders to check blood glucose levels at self-selected times.
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
Text message reminders to check blood glucose levels at self-selected times
Experimental: Text Message Group
Teen will receive text message reminders to check blood glucose levels at self-selected times.
Text message reminders to check blood glucose levels at self-selected times
No Intervention: Usual Care Group
Teen/family will receive routine clinical care for the first year of the study (the time period for assessment of primary outcomes). After year 1, teen/family will receive the Teenwork intervention at each remaining study visit and teen will receive text message reminders to check blood glucose levels at self-selected times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycemic control from baseline to 1 year
Time Frame: Baseline and 1 year
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
Baseline and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycemic control from 1 year to 18 months
Time Frame: 1 year and 18 months
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
1 year and 18 months
Psychosocial factors (self-report surveys)
Time Frame: Baseline, 6 months, 1 year, 18 months
We will assess psychosocial factors (e.g., diabetes-specific family conflict, diabetes burden, negative affect around blood glucose monitoring, quality of life, depressive symptoms, self-efficacy, disordered eating behaviors) every 6 months
Baseline, 6 months, 1 year, 18 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Barbara J. Anderson, PhD, Texas Children's Hospital/Baylor College 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.

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

November 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimate)

July 4, 2013

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-11
  • R01DK095273 (U.S. NIH Grant/Contract)

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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