Type 1 DiabetesNCT01892280
Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
A study testing Teenwork intervention and Text message reminders in people with Type 1 Diabetes, run by Joslin Diabetes Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Teenwork intervention and Text message reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Teenwork intervention, Text message reminders
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teenwork interventionBehavioural
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
Text message remindersBehavioural
Text message reminders to check blood glucose levels at self-selected times
| Study group | Role | What they receive |
|---|---|---|
| Teenwork Group | Experimental | Teen/family will receive the Teenwork intervention at each quarterly study visit. Receives: 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. Receives: Behavioral: Teenwork intervention; Behavioral: Text message reminders |
| Text Message Group | Experimental | Teen will receive text message reminders to check blood glucose levels at self-selected times. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: Baseline and 1 year
Secondary outcomes (2)
Change in glycemic control from 1 year to 18 months
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
Measured: 1 year and 18 months
Psychosocial factors (self-report surveys)
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
Measured: Baseline, 6 months, 1 year, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Lori Laffel, Joslin Diabetes Center
- Investigators
- Lori Laffel, MD, MPH, Principal investigator, Joslin Diabetes CenterBarbara J. Anderson, PhD, Principal investigator, Texas Children's Hospital/Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892280
- Sponsor's protocol ID
- 2012-11
- Other IDs
- R01DK095273
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2013
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28425183McGill 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.
PubMed 30734361Cecilia-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.
PubMed 30582670McGill 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.
PubMed 32357109Harrington 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.
PubMed 33431226
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study
- ClinicalTrials.gov ID
- NCT01892280
- Acronym / sponsor ID
- 2012-11
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Teenwork Group | Experimental | Behavioral: Teenwork interventionTeen/family will receive the Teenwork intervention at each quarterly study visit. |
| Teenwork/Text Message Group | Experimental | Behavioral: Teenwork intervention, Behavioral: Text message remindersTeen/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. |
| Text Message Group | Experimental | Behavioral: Text message remindersTeen will receive text message reminders to check blood glucose levels at self-selected times. |
| 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teenwork interventionSet of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration | Behavioural | Teenwork Group, Teenwork/Text Message Group |
| Text message remindersText message reminders to check blood glucose levels at self-selected times | Behavioural | Teenwork/Text Message Group, Text Message Group |
Primary outcome
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%)
2 secondary outcomes
Change in glycemic control from 1 year to 18 months
Time frame: 1 year and 18 months
Psychosocial factors (self-report surveys)
Time frame: Baseline, 6 months, 1 year, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Results publication: PubMed 28425183Commissariat 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.
- Results publication: PubMed 30734361McGill 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.
- Results publication: PubMed 30582670Cecilia-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.
- Results publication: PubMed 32357109McGill 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.
- Results publication: PubMed 33431226Harrington 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Laffel, MD, MPH principal investigator
Joslin Diabetes Center
Barbara J. Anderson, PhD principal investigator
Texas Children's Hospital/Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teenwork intervention and Text message reminders in people with Type 1 Diabetes, run by Joslin Diabetes Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic control from baseline to 1 year (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892280, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.