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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK095273 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teenwork Group | Experimental | Teen/family will receive the Teenwork intervention at each quarterly study visit. |
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| 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. |
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| Text Message Group | Experimental | Teen will receive text message reminders to check blood glucose levels at self-selected times. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teenwork intervention | Behavioral | Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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%) | 1 year and 18 months |
| Psychosocial factors (self-report surveys) |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Laffel, MD, MPH | Joslin Diabetes Center | Principal Investigator |
| Barbara J. Anderson, PhD | Texas Children's Hospital/Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States | ||
| Texas Children's Hospital/Baylor College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28425183 | Result | 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. | |
| 30734361 | Result | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Text message reminders | Behavioral | Text message reminders to check blood glucose levels at self-selected times |
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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 |
| Houston |
| Texas |
| 77030 |
| United States |
| 30582670 | Result | 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. |
| 32357109 | Result | 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. |
| 33431226 | Result | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |