Status:
COMPLETED
Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
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 g...
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 i...
Eligibility Criteria
Inclusion
- 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
- At least one clinic visit at the clinical site in the previous 12 months
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT01892280
Start Date
November 1 2013
End Date
August 1 2016
Last Update
August 10 2021
Active Locations (2)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
2
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States, 77030