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| ID | Type | Description | Link |
|---|---|---|---|
| 4-SRA-2021-1071-M-B | Other Grant/Funding Number | JUVENILE DIABETES RESEARCH FOUNDATION (JDRF) |
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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| DexCom, Inc. | INDUSTRY |
| Breakthrough T1D | OTHER |
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This project proposes to use telemedicine-delivered cognitive-behavioral therapy (CBT) enhanced with continuous glucose monitor (CGM) review to target diabetes distress in 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 93 adults (age 18-64) 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.
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 ecological momentary assessment (EMA) 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.
We will also collect qualitative information from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring | Experimental | Participants randomized to this arm will receive Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD), enhanced by review of Continuous Glucose Monitoring (CGM) data. Participants will wear study-supplied CGM for the first 6 months of their participation in the trial. |
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| Continuous Glucose Monitoring (CGM) Only | Active Comparator | Participants randomized to receive Continuous Glucose Monitoring (CGM) will continue to receive their usual care and will also wear CGM throughout the first 6 months of their participation in the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Diabetes Distress (CBT-DD) with Continuous Glucose Monitoring | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress Levels | Diabetes distress will be assessed using the Problem Areas in Diabetes (PAID) scale. The PAID scale will be administered to each participant via the REDCap database. The PAID scale is a 20 item, self-report questionnaire that describes negative emotions related to diabetes commonly experienced by people with diabetes. For each item, participants are asked to provide a response describing the extent the item is currently a diabetes issue for them using a 5-point Likert scale ranging from 0 ("Not a problem") to 4 ("Serious problem"). Scores are added and multiplied by 1.25, yielding an overall possible score of 0-100. Scores will be summarized by study arm using basic descriptive statistics. Patients scoring >=40 may be at the level of "emotional burnout" and warrant special attention. | Baseline and 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Hemoglobin A1c (HbA1c) values will be calculated using mailed point-of-care (POC) kits for home collection. Samples will be collected, returned, processed, and shipped for analysis by a central laboratory. HbA1c results will be summarized by study arm using basic descriptive statistics. | 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress Levels | Diabetes distress will be assessed using the Problem Areas in Diabetes (PAID) scale. The PAID scale will be administered to each participant via the REDCap database. The PAID scale is a 20 item, self-report questionnaire that describes negative emotions related to diabetes commonly experienced by people with diabetes. For each item, participants are asked to provide a response describing the extent the item is currently a diabetes issue for them using a 5-point Likert scale ranging from 0 ("Not a problem") to 4 ("Serious problem"). Scores are added and multiplied by 1.25, yielding an overall possible score of 0-100. Scores will be summarized by study arm using basic descriptive statistics. Patients scoring >=40 may be at the level of "emotional burnout" and warrant special attention. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Gonzalez, PhD | Yeshiva University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeshiva University | New York | New York | 10033 | United States | ||
| Albert Einstein College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27879358 | Background | 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. | |
| 10842426 | Background | Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2022 | Jul 13, 2022 |
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| Continuous Glucose Monitoring (CGM) | Device | 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. |
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| Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM) |
The percentage of time glucose values were within range (i.e., between 70-180 mg/dL) will be calculated from CGM data during the 3 months after randomization. Results will be summarized by study arm using basic descriptive statistics. |
| Every 14 days through the first 3 months post-intervention |
| Time Below Range (TBR) calculated from CGM | The percentage of time that glucose values were below range (i.e., ≤ 70 mg/dL and ≤ 55 mg/dL) will be calculated from CGM data during the 3 months after randomization. Percentage of TBR will be calculated for both thresholds. Results will be summarized by study arm using basic descriptive statistics. | Every 14 days through the first 3 months post-intervention |
| Time Above Range (TAR) calculated from CGM | The percentage of time glucose values were above range (≥ 180 mg/dL and ≥ 250 mg/dL) will be calculated from CGM wear data during the 3 months after randomization. Percentage of TAR will be calculated for both thresholds. Results will be summarized by study arm using basic descriptive statistics. | Every 14 days through the first 3 months post-intervention |
| Coefficient of Variation (CV) for Glycemic Variability | The CV for glycemic variability will be calculated based on the values obtained from CGM. CV, which is a measure of variability, is defined as the standard deviation of glucose changes divided by the mean glucose value and will expressed as a percentage. Results will be summarized by study arm. | Every 14 days through the first 3 months post-intervention |
| Baseline and 6 months, 9 months and 12 months post-intervention |
| Hemoglobin A1c | Hemoglobin A1c (HbA1c) values will be calculated from mailed kits for home collection and analysis by a central laboratory. | 6 months, 9 months, and 12 months post-intervention |
| The Bronx |
| New York |
| 10461 |
| United States |
| 22025785 | Background | 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. |
| 30657336 | Background | 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. |
| 25998289 | Background | 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. |
| 25562264 | Background | 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. |
| 22150528 | Background | 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. |
| 28245334 | Background | 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. |
| 11522695 | Background | 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. |
| 12663572 | Background | 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. |
| 23952498 | Background | 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. |
| 28874224 | Background | 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. |
| Background | 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 |
| 25906787 | Background | 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. |
| 29351961 | Background | 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. |
| 31244396 | Background | 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. |
| 7555499 | Background | 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. |
| Background | American Diabetes Association 85th Scientific Sessions. Identifying Diabetes Distress across Adult Age Groups-Insights from the ReDUCe Study. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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