Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— ReDUCe  

Official title:

Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000021
• Other study ID #: 2021-12789
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Albert Einstein College of Medicine
• Contact: Shivani Agarwal, MD, MPH
• Phone: 844-556-6683
• Email: Shivani.agarwal[@]einsteinmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in young adults with type 1 diabetes. The efficacy of CBT for diabetes distress (CBT-DD) will be tested in comparison to commercial FDA-approved CGM only in a randomized controlled clinical trial. The investigators central hypothesis is that the addition of a CBT intervention that targets diabetes distress and self-management directly will yield clinically significant improvements in both diabetes distress and glycemic control relative to CGM alone. The investigators propose to recruit 150 young adults (age 18-35) with type 1 diabetes from a national population for an entirely virtual 6-month study over four years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of HbA1c for glycemic control and validated patient-reported outcome (PRO) surveys, the investigators plan to innovatively integrate momentary psychological and behavioral data via smartphone-based ecological momentary assessment with CGM data to assess day-to-day changes in diabetes distress, affect, self-management, and glycemia over the course of the trial.

Description:

The investigators propose a randomized controlled trial (RCT) of CBT-DD, enhanced by CGM feedback. The study period will last for 6 months, with the first 3 months on CGM and consisting of a 2-week run-in period prior to randomization, in which EMA (ecological momentary assessment) data will be collected daily, followed by an 8-week CBT intervention period in which EMA data will be collected weekly surrounding CBT sessions, with a subsequent 2-week period post-intervention in which EMA data will again be collected daily. Both intervention and control groups will be doing the same EMA and CGM procedures to enable matching data for comparison. Follow-up virtual study data collection will occur at 3, 6, 9, and 12 months to assess the primary outcome of HbA1c and durability of intervention effect on diabetes distress and HbA1c. Participants in both arms will be provided a sufficient supply of CGM sensors to track their blood glucose daily, throughout the first 6 months of the study. If participants already have personal CGM, they will replace with study-supplied CGM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

-Diabetes Distress

Exclusion Criteria:

• Comorbid psychiatric condition (e.g. depression, anxiety, or suicidality).

• In treatment for a psychological condition within the last 6 months

• On a non-stable dose of psychiatric medication over the past 2 months

• Developmental or sensory disability interfering with participation

• Current pregnancy, as self-management and glycemic goals differ

• Participations in another behavioral intervention study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring
CBT-DD consists of approximately 10 individual sessions of CBT delivered virtually by trained protocol therapists, conducted over the course of approximately 12 weeks. The CBT-DD consists of 5 core modules targeting negative emotionality and aversive reactions to emotional experiences. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. The final module consists of relapse prevention. CBT-DD sessions will integrate a review of Continuous Glucose Monitoring (CGM) data and feedback will be provided by the therapist.

Device:
• Continuous Glucose Monitoring (CGM)
Use of commercially available, FDA-approved continuous glucose monitoring (CGM) for 6 months post-randomization. Usual diabetes care will continue and participants can initiate a CGM review from their healthcare providers, as desired. In addition, a nurse practitioner with expertise in CGM will train each participant via video recordings in the proper placement of the device, and technical issues, and provide basic teaching at the beginning of the trial on interpretation of CGM data and self-titration of insulin/self-management. Written materials and online resources for recognizing and managing diabetes distress, along with self-management information and treatment options to discuss with providers will also be provided.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Yeshiva University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	DexCom, Inc., Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (17)

2014 Diabetes Health Care Cost Institute Utilization Report. Health Care Cost Institute. Published 2014. Accessed October 3, 2021. https://healthcostinstitute.org/images/easyblog_ articles/276/HCCI-2017-Health-Care-Cost-and-Utilization-Report-02.12.19.pdf

Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80. — View Citation

Bakhach M, Reid MW, Pyatak EA, Berget C, Cain C, Thomas JF, Klingensmith GJ, Raymond JK. Home Telemedicine (CoYoT1 Clinic): A Novel Approach to Improve Psychosocial Outcomes in Young Adults With Diabetes. Diabetes Educ. 2019 Aug;45(4):420-430. doi: 10.1177/0145721719858080. Epub 2019 Jun 27. — View Citation

Bryden KS, Dunger DB, Mayou RA, Peveler RC, Neil HA. Poor prognosis of young adults with type 1 diabetes: a longitudinal study. Diabetes Care. 2003 Apr;26(4):1052-7. doi: 10.2337/diacare.26.4.1052. — View Citation

Bryden KS, Peveler RC, Stein A, Neil A, Mayou RA, Dunger DB. Clinical and psychological course of diabetes from adolescence to young adulthood: a longitudinal cohort study. Diabetes Care. 2001 Sep;24(9):1536-40. doi: 10.2337/diacare.24.9.1536. — View Citation

Dabelea D, Stafford JM, Mayer-Davis EJ, D'Agostino R Jr, Dolan L, Imperatore G, Linder B, Lawrence JM, Marcovina SM, Mottl AK, Black MH, Pop-Busui R, Saydah S, Hamman RF, Pihoker C; SEARCH for Diabetes in Youth Research Group. Association of Type 1 Diabetes vs Type 2 Diabetes Diagnosed During Childhood and Adolescence With Complications During Teenage Years and Young Adulthood. JAMA. 2017 Feb 28;317(8):825-835. doi: 10.1001/jama.2017.0686. — View Citation

Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18. Erratum In: Diabetes Technol Ther. 2019 Apr;21(4):230. — View Citation

Johnson B, Elliott J, Scott A, Heller S, Eiser C. Medical and psychological outcomes for young adults with Type 1 diabetes: no improvement despite recent advances in diabetes care. Diabet Med. 2014 Feb;31(2):227-31. doi: 10.1111/dme.12305. Epub 2013 Sep 19. — View Citation

Livingstone SJ, Levin D, Looker HC, Lindsay RS, Wild SH, Joss N, Leese G, Leslie P, McCrimmon RJ, Metcalfe W, McKnight JA, Morris AD, Pearson DW, Petrie JR, Philip S, Sattar NA, Traynor JP, Colhoun HM; Scottish Diabetes Research Network epidemiology group; Scottish Renal Registry. Estimated life expectancy in a Scottish cohort with type 1 diabetes, 2008-2010. JAMA. 2015 Jan 6;313(1):37-44. doi: 10.1001/jama.2014.16425. — View Citation

Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078. — View Citation

Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. No abstract available. Erratum In: Diabetes Care. 2012 Jan;35(1):191. — View Citation

Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754. — View Citation

Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19. — View Citation

Rhodes ET, Prosser LA, Hoerger TJ, Lieu T, Ludwig DS, Laffel LM. Estimated morbidity and mortality in adolescents and young adults diagnosed with Type 2 diabetes mellitus. Diabet Med. 2012 Apr;29(4):453-63. doi: 10.1111/j.1464-5491.2011.03542.x. — View Citation

Rodwell L, Romaniuk H, Nilsen W, Carlin JB, Lee KJ, Patton GC. Adolescent mental health and behavioural predictors of being NEET: a prospective study of young adults not in employment, education, or training. Psychol Med. 2018 Apr;48(5):861-871. doi: 10.1017/S0033291717002434. Epub 2017 Sep 6. — View Citation

Sequeira PA, Pyatak EA, Weigensberg MJ, Vigen CP, Wood JR, Ruelas V, Montoya L, Cohen M, Speer H, Clark S, Peters AL. Let's Empower and Prepare (LEAP): Evaluation of a Structured Transition Program for Young Adults With Type 1 Diabetes. Diabetes Care. 2015 Aug;38(8):1412-9. doi: 10.2337/dc14-2577. Epub 2015 Apr 23. — View Citation

Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Dec;39(12):2126-2140. doi: 10.2337/dc16-2053. No abstract available. Erratum In: Diabetes Care. 2017 Feb;40(2):287. Diabetes Care. 2017 May;40(5):726. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetes Distress Levels	The Problem Areas in Diabetes (PAID) scale will be administered	6 month mark
Other	Diabetes Distress Levels	The Problem Areas in Diabetes (PAID) scale will be administered	9 month mark
Other	Diabetes Distress Levels	The Problem Areas in Diabetes (PAID) scale will be administered	12 month mark
Other	Hemoglobin A1c	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.	6 month month mark
Other	Hemoglobin A1c	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.	9 month month mark
Other	Hemoglobin A1c	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.	12 month month mark
Primary	Diabetes Distress Levels	The Problem Areas in Diabetes (PAID) scale will be administered	3 month mark (post-intervention)
Secondary	Hemoglobin A1c	Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory.	3 month mark (post-intervention)
Secondary	Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)	Percent of time with glucose values between 70-180 mg/dl will be calculated from CGM wear in the 3 months after randomization.	3 month mark (post-intervention)
Secondary	Time Below Range (TBR) calculated from Continuous Glucose Monitoring (CGM)	Percent of time with glucose values below 70 mg/dl will be calculated from CGM wear in the 3 months after randomization.	3 month mark (post-intervention)
Secondary	Time Above Range (TAR) calculated from Continuous Glucose Monitoring (CGM)	Percent of time with glucose values above 180 mg/dl will be calculated from CGM wear in the 3 months after randomization.	3 month mark (post-intervention)
Secondary	Coefficient of Variation (CV) calculated from Continuous Glucose Monitoring (CGM)	The CV is the standard deviation of glucose changes divided by the mean glucose value	3 month mark (post-intervention)