NCT01892280

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 glucose levels can help improve blood glucose levels in teens with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

July 1, 2013

Last Update Submit

August 3, 2021

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in glycemic control from baseline to 1 year

    Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)

    Baseline and 1 year

Secondary Outcomes (2)

  • Change in glycemic control from 1 year to 18 months

    1 year and 18 months

  • Psychosocial factors (self-report surveys)

    Baseline, 6 months, 1 year, 18 months

Study Arms (4)

Teenwork Group

EXPERIMENTAL

Teen/family will receive the Teenwork intervention at each quarterly study visit.

Behavioral: Teenwork intervention

Teenwork/Text Message Group

EXPERIMENTAL

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.

Behavioral: Teenwork interventionBehavioral: Text message reminders

Text Message Group

EXPERIMENTAL

Teen will receive text message reminders to check blood glucose levels at self-selected times.

Behavioral: Text message reminders

Usual Care Group

NO INTERVENTION

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.

Interventions

Teenwork interventionBEHAVIORAL

Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration

Teenwork GroupTeenwork/Text Message Group
Text message remindersBEHAVIORAL

Text message reminders to check blood glucose levels at self-selected times

Teenwork/Text Message GroupText Message Group

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Texas Children's Hospital/Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (5)

  • Commissariat PV, Volkening LK, Guo Z, ElBach JL, Butler DA, Laffel LM. Associations between major life events and adherence, glycemic control, and psychosocial characteristics in teens with type 1 diabetes. Pediatr Diabetes. 2018 Feb;19(1):85-91. doi: 10.1111/pedi.12523. Epub 2017 Apr 19.

    PMID: 28425183RESULT

  • McGill DE, Volkening LK, Butler DA, Wasserman RM, Anderson BJ, Laffel LM. Text-message responsiveness to blood glucose monitoring reminders is associated with HbA1c benefit in teenagers with Type 1 diabetes. Diabet Med. 2019 May;36(5):600-605. doi: 10.1111/dme.13929. Epub 2019 Feb 25.

    PMID: 30734361RESULT

  • Cecilia-Costa R, Volkening LK, Laffel LM. Factors associated with disordered eating behaviours in adolescents with Type 1 diabetes. Diabet Med. 2019 Aug;36(8):1020-1027. doi: 10.1111/dme.13890. Epub 2019 Mar 4.

    PMID: 30582670RESULT

  • McGill DE, Laffel LM, Volkening LK, Butler DA, Levy WL, Wasserman RM, Anderson BJ. Text Message Intervention for Teens with Type 1 Diabetes Preserves HbA1c: Results of a Randomized Controlled Trial. Diabetes Technol Ther. 2020 May;22(5):374-382. doi: 10.1089/dia.2019.0350.

    PMID: 32357109RESULT

  • Harrington KR, Shapira A, Volkening LK, Butler DA, Anderson BJ, Wasserman RM, Laffel LM. Associations of diabetes self-management characteristics, HbA1c, and psychosocial outcomes with depressive symptoms in a contemporary sample of adolescents with type 1 diabetes. J Diabetes Complications. 2021 Mar;35(3):107838. doi: 10.1016/j.jdiacomp.2020.107838. Epub 2021 Jan 6.

    PMID: 33431226RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Lori Laffel, MD, MPH

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

  • Barbara J. Anderson, PhD

    Texas Children's Hospital/Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 4, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations

US(2)