Antonina Mikocka-Walus, JPR’s Deputy Editor
Jess Fiedorowicz, JPR’s Editor-in-Chief
“Fear Less: Cognitive Behavioural Therapy’s Role in Managing Hypoglycemia Anxiety and Type 1 Diabetes Mellitus in Young Adults”
We have selected a randomized controlled trial by Martyn-Nemeth and colleagues at the University of Illinois – Chicago for this quarter’s Editor’s Choice.1 This study was inspired by the volunteer experiences of two team members at week-long summer camps sponsored by the American Diabetes Association for children with type 1 diabetes (T1D) mellitus. The first author, Pamela Martyn-Nemeth, volunteered as a camp nurse, regularly addressing campers’ concerns about hypoglycemia. Staff monitored campers with glucometers and provided glucose tablets when needed. Some campers were so anxious about hypoglycemia that they insisted on being woken overnight to check their blood sugar levels. Co-author Laurie Quinn also volunteered there as a health team coordinator for more than a decade. These camp experiences led to an appreciation of the relevance of fear of hypoglycemia for youth with T1D and inspired the trial highlighted as this Editor’s Choice, “FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy (CBT) and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes.” The authors briefly summarize their study with the following:
All persons with T1D are at risk for hypoglycemia (low blood sugar), a life-threatening situation which leads to profound fear of hypoglycemia (FOH). FOH results in poor glucose control and fluctuations in glucose that are associated with diabetes complications. The investigators conducted a clinical trial to test a Fear Reduction Efficacy Evaluation (FREE), an 8-week CBT intervention, to enhance FOH management capacity, compared to an attention control (diabetes education) in 50 young adults (age 18 to 35) with T1D. The participants in FREE experienced a significant reduction in FOH (8.52%) and improved glucose time-in-range (8.92%) compared to controls.
The authors thoughtfully selected fear of hypoglycemia as their primary outcome for this randomized controlled trial based on its impact on young adults with T1D and its potential to influence other clinical outcomes. Given its potentially life-threatening nature, fear of hypoglycemia is a natural reaction to managing T1D, which requires insulin treatment. The authors note that fear of hypoglycemia is associated with a variety of clinical outcomes, including reduced insulin dosing, increased carbohydrate intake, and decreased exercise.2-4 Each of these may result in worse glycemic control and subsequent long-term adverse diabetes outcomes. As born out in their camp experiences, fear of hypoglycemia is also associated with anxiety, distress, impaired function, and reduced quality of life.5 A treatment that targets fear of hypoglycemia has the potential therefore to yield additional benefits. Two of these benefits, which are more traditional outcomes of trials for diabetes, were prospectively registered as secondary outcomes on clinicaltrials.gov: change in hemoglobin A1c and change in glucose variability (registered as the SD in hemoglobin A1c).
The intervention consisted of eight weekly, one-hour individual sessions of CBT. The CBT intervention was adapted from CBT for anxiety but tailored to fear of hypoglycemia and T1D and given with biofeedback from real time continuous glucose monitoring (78% already used this before the study). The control group also received continuous glucose monitoring and eight weekly one-hour individualized diabetes education sessions. Controls did not however receive training on use of the continuous glucose monitoring as a biofeedback tool. Both treatments were manualized and subject to random fidelity checks. Groups were reasonably balanced after randomization although those randomized to the FREE intervention had a duration of diabetes an average of four years longer and had slightly worse glycemic control at baseline (HbA1c of 7.4 vs. 7.0%).
The FREE intervention resulted in a significant improvement in fear of hypoglycemia with a moderate effect size (~ 0.5 SD). No significant group differences emerged for the secondary outcomes of change in Hemoglobin A1C or glucose SD. In their discussion, the authors speculate that improvements in fear of hypoglycemia may not have translated into improved outcomes in terms of glycemic control or glycemic variability given that the small sample was reasonably controlled at baseline. The American Diabetic Association guidelines recommend a target hemoglobin A1c <7.0% for many children and <7.5% for others (e.g., hypoglycemia unawareness, or lack access to continuous glucose monitoring).6 The primary and secondary outcomes were registered at the week 8 timepoint and analyses were conducted at week 8 and week 12. The promising improvements in fear of hypoglycemia warrant further study in larger samples with longer term follow-up to determine if they improve glycemic control, variability, and other diabetes outcomes. Regardless, fear of hypoglycemia may be a worthy outcome, as illustrated in the investigators’ experience volunteering at diabetes camps. Fear of hypoglycemia is also adversely associated with greater distress and lower quality of life.5 We are pleased to laud the efforts of this investigative team in addressing the needs of this population in both their research and volunteer work.
The Journal of Psychosomatic Research is committed to disseminating clinical trials within our scope at the interface of psychology and medicine. Clinical trials receive special priority for review and a clear commitment to work with the authors to prepare for publication in line with CONSORT guidelines7,8 regardless of whether the results are positive or negative. We stringently follow the well-established (~20 years) ICMJE guidelines of only publishing clinical trials that have been prospectively registered in a registry that is a primary register of the WHO International Clinical Trials Registry Platform9,10 and will verify that primary and secondary outcomes are clearly delineated and match what was prospectively registered. If you and your team are embarking on a clinical trial at the interface of psychology and medicine, please consider us to shepherd your first submission to publication.
REFERENCES:
- Martyn-Nemeth P, Duffecy J, Quinn L, et al. FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes. J Psychosom Res. Jun 2024;181:111679. doi:10.1016/j.jpsychores.2024.111679
- Ahola AJ, Saraheimo M, Freese R, et al. Fear of hypoglycaemia and self-management in type 1 diabetes. J Clin Transl Endocrinol. Jun 2016;4:13-18. doi:10.1016/j.jcte.2016.02.002
- Jabbour G, Henderson M, Mathieu ME. Barriers to Active Lifestyles in Children with Type 1 Diabetes. Can J Diabetes. Apr 2016;40(2):170-2. doi:10.1016/j.jcjd.2015.12.001
- Pinsker JE, Kraus A, Gianferante D, et al. Techniques for Exercise Preparation and Management in Adults with Type 1 Diabetes. Can J Diabetes. Dec 2016;40(6):503-508. doi:10.1016/j.jcjd.2016.04.010
- Liu J, Bispham J, Fan L, et al. Factors associated with fear of hypoglycaemia among the T1D Exchange Glu population in a cross-sectional online survey. BMJ Open. Sep 06 2020;10(9):e038462. doi:10.1136/bmjopen-2020-038462
- Committee ADAPP. 14. Children and Adolescents: Standards of Medical Care in Diabetes-2022. Diabetes Care. Jan 01 2022;45(Suppl 1):S208-S231. doi:10.2337/dc22-S014
- Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. Mar 23 2010;340:c332. doi:10.1136/bmj.c332
- Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. Dec 13 2022;328(22):2252-2264. doi:10.1001/jama.2022.21022
- De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. CMAJ. Sep 14 2004;171(6):606-7. doi:10.1503/cmaj.1041281
- De Angelis C, Drazen J, Frizelle F, et al. Clinical Trial Registration: A Statement from the International
Committee of Medical Journal Editors. https://www.icmje.org/news-and-editorials/clin_trial_sep2004.pdf. Accessed 14 October, 2024.
Pamela Martyn-Nemeth, Jennifer Duffecy, Laurie Quinn, Chang Park, Sirimon Reutrakul, Dan Mihailescu, Minsun Park, Sue Penckofer
Vol. 181, June 2024
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