Appl Clin Inform 2023; 14(01): 037-044
DOI: 10.1055/a-1975-4136
Research Article

Continuous Glucose Monitoring and Other Wearable Devices to Assess Hypoglycemia among Older Adult Outpatients with Diabetes Mellitus

Michael Weiner
1   Department of Medicine, Indiana University, Indianapolis, Indiana
2   Center for Health Services Research, Regenstrief Institute, Inc., Indianapolis, Indiana
3   Center for Health Information and Communication, Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service CIN 13–416, Richard L. Roudebush VA Medical Center, Indianapolis, Indiana
,
Philip Adeoye
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Margaret J. Boeh
5   Senior Care, Eskenazi Health, Indianapolis, Indiana
,
Kunal Bodke
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Jessica Broughton
5   Senior Care, Eskenazi Health, Indianapolis, Indiana
,
Anietra R. Butler
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Mackenzie L. Dafferner
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Lindsay A. Dirlam
6   Lifestyle Health and Wellness, Eskenazi Health, Indianapolis, Indiana
,
Denisha Ferguson
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Amanda L. Keegan
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
NiCole R. Keith
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
7   Department of Kinesiology, Indiana University, Indianapolis, Indiana
,
Joy L. Lee
1   Department of Medicine, Indiana University, Indianapolis, Indiana
2   Center for Health Services Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Corrina B. McCorkle
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Daniel G. Pino
1   Department of Medicine, Indiana University, Indianapolis, Indiana
6   Lifestyle Health and Wellness, Eskenazi Health, Indianapolis, Indiana
,
Mu Shan
8   Department of Biostatistics and Health Data Science, Indiana University, Indianapolis, Indiana
,
Preethi Srinivas
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Qing Tang
8   Department of Biostatistics and Health Data Science, Indiana University, Indianapolis, Indiana
,
Evgenia Teal
9   Data Services, Regenstrief Institute, Inc., Indianapolis, Indiana
,
Wanzhu Tu
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
8   Department of Biostatistics and Health Data Science, Indiana University, Indianapolis, Indiana
,
April Savoy
2   Center for Health Services Research, Regenstrief Institute, Inc., Indianapolis, Indiana
3   Center for Health Information and Communication, Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service CIN 13–416, Richard L. Roudebush VA Medical Center, Indianapolis, Indiana
10   Computer and Information Technology, Purdue School of Engineering and Technology, Indiana University-Purdue University Indianapolis, Indiana
,
Christopher M. Callahan
1   Department of Medicine, Indiana University, Indianapolis, Indiana
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
5   Senior Care, Eskenazi Health, Indianapolis, Indiana
,
Daniel O. Clark
1   Department of Medicine, Indiana University, Indianapolis, Indiana
4   Center for Aging Research, Regenstrief Institute, Inc., Indianapolis, Indiana
› Institutsangaben
Funding This study was supported by the Agency for Healthcare Research and Quality (grant no.: P30HS024384).

Abstract

Background Hypoglycemia (HG) causes symptoms that can be fatal, and confers risk of dementia. Wearable devices can improve measurement and feedback to patients and clinicians about HG events and risk.

Objectives The aim of the study is to determine whether vulnerable older adults could use wearables, and explore HG frequency over 2 weeks.

Methods First, 10 participants with diabetes mellitus piloted a continuous glucometer, physical activity monitor, electronic medication bottles, and smartphones facilitating prompts about medications, behaviors, and symptoms. They reviewed graphs of glucose values, and were asked about the monitoring experience. Next, a larger sample (N = 70) wore glucometers and activity monitors, and used the smartphone and bottles, for 2 weeks. Participants provided feedback about the devices. Descriptive statistics summarized demographics, baseline experiences, behaviors, and HG.

Results In the initial pilot, 10 patients aged 50 to 85 participated. Problems addressed included failure of the glucometer adhesive. Patients sought understanding of graphs, often requiring some assistance with interpretation. Among 70 patients in subsequent testing, 67% were African-American, 59% were women. Nearly one-fourth (23%) indicated that they never check their blood sugars. Previous HG was reported by 67%. In 2 weeks of monitoring, 73% had HG (glucose ≤70 mg/dL), and 42% had serious, clinically significant HG (glucose under 54 mg/dL). Eight patients with HG also had HG by home-based blood glucometry. Nearly a third of daytime prompts were unanswered. In 24% of participants, continuous glucometers became detached.

Conclusion Continuous glucometry occurred for 2 weeks in an older vulnerable population, but devices posed wearability challenges. Most patients experienced HG, often serious in magnitude. This suggests important opportunities to improve wearability and decrease HG frequency among this population.

Note

Aspects of this work were presented at Improving Primary Care through Industrial and Systems Engineering (i-PrACTISE), Boston, MA, June 3, 2019; and The Scottsdale Institute, February 27, 2020.


M.W. is Chief of Health Services Research and Development at the Richard L. Roudebush Veterans Affairs Medical Center in Indianapolis, Indiana. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs.




Publikationsverlauf

Eingereicht: 08. Mai 2022

Angenommen: 25. Oktober 2022

Accepted Manuscript online:
09. November 2022

Artikel online veröffentlicht:
18. Januar 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Gonder-Frederick LA, Cox DJ, Bobbitt SA, Pennebaker JW. Mood changes associated with blood glucose fluctuations in insulin-dependent diabetes mellitus. Health Psychol 1989; 8 (01) 45-59
  • 2 Amiel SA, Dixon T, Mann R, Jameson K. Hypoglycaemia in type 2 diabetes. Diabet Med 2008; 25 (03) 245-254
  • 3 Ben-Ami H, Nagachandran P, Mendelson A, Edoute Y. Drug-induced hypoglycemic coma in 102 diabetic patients. Arch Intern Med 1999; 159 (03) 281-284
  • 4 Hsu P-F, Sung S-H, Cheng H-M. et al. Association of clinical symptomatic hypoglycemia with cardiovascular events and total mortality in type 2 diabetes: a nationwide population-based study. Diabetes Care 2013; 36 (04) 894-900
  • 5 Marrett E, Radican L, Davies MJ, Zhang Q. Assessment of severity and frequency of self-reported hypoglycemia on quality of life in patients with type 2 diabetes treated with oral antihyperglycemic agents: a survey study. BMC Res Notes 2011; 4: 251
  • 6 Davis RE, Morrissey M, Peters JR, Wittrup-Jensen K, Kennedy-Martin T, Currie CJ. Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin 2005; 21 (09) 1477-1483
  • 7 Clarke WL, Cox DJ, Gonder-Frederick LA, Julian D, Schlundt D, Polonsky W. Reduced awareness of hypoglycemia in adults with IDDM. A prospective study of hypoglycemic frequency and associated symptoms. Diabetes Care 1995; 18 (04) 517-522
  • 8 Chan S-P, Ji L-N, Nitiyanant W, Baik SH, Sheu WH-H. Hypoglycemic symptoms in patients with type 2 diabetes in Asia-Pacific-Real-life effectiveness and care patterns of diabetes management: the RECAP-DM study. Diabetes Res Clin Pract 2010; 89 (02) e30-e32
  • 9 Alvarez Guisasola F, Tofé Povedano S, Krishnarajah G, Lyu R, Mavros P, Yin D. Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study. Diabetes Obes Metab 2008; 10 (Suppl. 01) 25-32
  • 10 Bullano MF, Al-Zakwani IS, Fisher MD, Menditto L, Willey VJ. Differences in hypoglycemia event rates and associated cost-consequence in patients initiated on long-acting and intermediate-acting insulin products. Curr Med Res Opin 2005; 21 (02) 291-298
  • 11 Janka HU, Plewe G, Busch K. Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. J Am Geriatr Soc 2007; 55 (02) 182-188
  • 12 Briscoe VJ, Davis SN. Hypoglycemia in type 1 and type 2 diabetes: physiology, pathophysiology, and management. Clin Diabetes 2006; 24 (03) 115-121
  • 13 UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352 (9131): 837-853
  • 14 Nathan DM, Genuth S, Lachin J. et al; Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329 (14) 977-986
  • 15 Torimoto K, Okada Y, Hajime M, Tanaka K, Tanaka Y. Risk factors of hypoglycemia in patients with type 2 diabetes mellitus: a study based on continuous glucose monitoring. Diabetes Technol Ther 2018; 20 (09) 603-612
  • 16 Li X, Yu S, Zhang Z. et al. Predictive modeling of hypoglycemia for clinical decision support in evaluating outpatients with diabetes mellitus. Curr Med Res Opin 2019; 35 (11) 1885-1891 DOI: 10.1080/03007995.2019.1636016.
  • 17 Walker RJ, Strom Williams J, Egede LE. Influence of Race, Ethnicity and Social Determinants of Health on Diabetes Outcomes. Am J Med Sci 2016; 351 (04) 366-373
  • 18 Walker RJ, Smalls BL, Campbell JA, Strom Williams JL, Egede LE. Impact of social determinants of health on outcomes for type 2 diabetes: a systematic review. Endocrine 2014; 47 (01) 29-48
  • 19 Hill-Briggs F, Adler NE, Berkowitz SA. et al. Social determinants of health and diabetes: a scientific review. Diabetes Care 2020; 44 (01) 258-279
  • 20 Moreno G, Mangione CM, Kimbro L, Vaisberg E. American Geriatrics Society Expert Panel on Care of Older Adults with Diabetes Mellitus. Guidelines abstracted from the American Geriatrics Society Guidelines for improving the care of older adults with diabetes mellitus: 2013 update. J Am Geriatr Soc 2013; 61 (11) 2020-2026
  • 21 Lee SJ, Boscardin WJ, Stijacic Cenzer I, Huang ES, Rice-Trumble K, Eng C. The risks and benefits of implementing glycemic control guidelines in frail older adults with diabetes mellitus. J Am Geriatr Soc 2011; 59 (04) 666-672
  • 22 Strachan MWJ, Reynolds RM, Marioni RE, Price JF. Cognitive function, dementia and type 2 diabetes mellitus in the elderly. Nat Rev Endocrinol 2011; 7 (02) 108-114
  • 23 Ninomiya T. Diabetes mellitus and dementia. Curr Diab Rep 2014; 14 (05) 487
  • 24 Whitmer RA, Karter AJ, Yaffe K, Quesenberry Jr. CP, Selby JV. Hypoglycemic episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA 2009; 301 (15) 1565-1572
  • 25 Yaffe K, Falvey CM, Hamilton N. et al; Health ABC Study. Association between hypoglycemia and dementia in a biracial cohort of older adults with diabetes mellitus. JAMA Intern Med 2013; 173 (14) 1300-1306
  • 26 Feinkohl I, Aung PP, Keller M. et al; Edinburgh Type 2 Diabetes Study (ET2DS) Investigators. Severe hypoglycemia and cognitive decline in older people with type 2 diabetes: the Edinburgh type 2 diabetes study. Diabetes Care 2014; 37 (02) 507-515
  • 27 Klonoff DC, Buckingham B, Christiansen JS. et al; Endocrine Society. Continuous glucose monitoring: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2011; 96 (10) 2968-2979
  • 28 Pratley RE, Kanapka LG, Rickels MR. et al; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of continuous glucose monitoring on hypoglycemia in older adults with type 1 diabetes: a randomized clinical trial. JAMA 2020; 323 (23) 2397-2406
  • 29 Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42 (02) 377-381
  • 30 Harris PA, Taylor R, Minor BL. et al; REDCap Consortium. The REDCap consortium: building an international community of software platform partners. J Biomed Inform 2019; 95: 103208
  • 31 Massa GG, Gys I, Op 't Eyndt A. et al. Evaluation of the FreeStyle® Libre flash glucose monitoring system in children and adolescents with type 1 diabetes. Horm Res Paediatr 2018; 89 (03) 189-199
  • 32 Beck RW, Riddlesworth T, Ruedy K. et al; DIAMOND Study Group. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND randomized clinical trial. JAMA 2017; 317 (04) 371-378
  • 33 Lind M, Polonsky W, Hirsch IB. et al. Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the GOLD randomized clinical trial. JAMA 2017; 317 (04) 379-387
  • 34 Laffel LM, Kanapka LG, Beck RW. et al; CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group, CDE10. Effect of continuous glucose monitoring on glycemic control in adolescents and young adults with type 1 diabetes: a randomized clinical trial. JAMA 2020; 323 (23) 2388-2396
  • 35 Ratna S, Subashini R, Unnikrishnan R, Mohan V. Use of freestyle libre ProTM flash glucose monitoring system in different clinical situations at a diabetes centre. J Assoc Physicians India 2017; 65 (08) 18-23
  • 36 Saleem JJ, Wilck NR, Murphy JJ, Herout J. Veteran and staff experience from a pilot program of health care system-distributed wearable devices and data sharing. Appl Clin Inform 2022; 13 (03) 532-540
  • 37 Karway G, Grando MA, Grimm K, Groat D, Cook C, Thompson B. Self-management behaviors of patients with type 1 diabetes: comparing two sources of patient-generated data. Appl Clin Inform 2020; 11 (01) 70-78
  • 38 Groat D, Soni H, Grando MA, Thompson B, Kaufman D, Cook CB. Design and testing of a smartphone application for real-time self-tracking diabetes self-management behaviors. Appl Clin Inform 2018; 9 (02) 440-449
  • 39 Watson AJ, Grant RW, Bello H, Hoch DB. Brave new worlds: how virtual environments can augment traditional care in the management of diabetes. J Diabetes Sci Technol 2008; 2 (04) 697-702
  • 40 Cox DJ, Kovatchev B, Koev D. et al. Hypoglycemia anticipation, awareness and treatment training (HAATT) reduces occurrence of severe hypoglycemia among adults with type 1 diabetes mellitus. Int J Behav Med 2004; 11 (04) 212-218
  • 41 Kuo A, Dang S. Secure messaging in electronic health records and its impact on diabetes clinical outcomes: a systematic review. Telemed J E Health 2016; 22 (09) 769-777
  • 42 Huang ES, Nathan AG, Cooper JM. et al. Impact and feasibility of personalized decision support for older patients with diabetes: a pilot randomized trial. Med Decis Making 2017; 37 (05) 611-617
  • 43 Montori VM, Fernández-Balsells M. Glycemic control in type 2 diabetes: time for an evidence-based about-face?. Ann Intern Med 2009; 150 (11) 803-808
  • 44 Watson AJ, Kvedar JC, Rahman B, Pelletier AC, Salber G, Grant RW. Diabetes connected health: a pilot study of a patient- and provider-shared glucose monitoring web application. J Diabetes Sci Technol 2009; 3 (02) 345-352
  • 45 Kim H-S, Jeong YJ, Baik SJ. et al. Social networking services-based communicative care for patients with diabetes mellitus in Korea. Appl Clin Inform 2016; 7 (03) 899-911
  • 46 Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care 2011; 34 (09) 1934-1942
  • 47 Rollo ME, Ash S, Lyons-Wall P, Russell A. Trial of a mobile phone method for recording dietary intake in adults with type 2 diabetes: evaluation and implications for future applications. J Telemed Telecare 2011; 17 (06) 318-323
  • 48 Desendorf J, Bassett Jr DR, Raynor HA, Coe DP. Validity of the Bite Counter device in a controlled laboratory setting. Eat Behav 2014; 15 (03) 502-504
  • 49 Lu T-C, Fu C-M, Ma MH-M, Fang C-C, Turner AM. Healthcare applications of smart watches. a systematic review. Appl Clin Inform 2016; 7 (03) 850-869
  • 50 Baig MM, GholamHosseini H, Gutierrez J, Ullah E, Lindén M. Early detection of prediabetes and T2DM using wearable sensors and internet-of-things-based monitoring applications. Appl Clin Inform 2021; 12 (01) 1-9
  • 51 U.S. Food & Drug Administration. Summary of safety and effectiveness data: Freestyle Libre Pro Flash Glucose Monitoring System. Published 2016. Accessed September 14, 2020 at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150021B.pdf
  • 52 Alitta Q, Grino M, Adjemout L, Langar A, Retornaz F, Oliver C. Overestimation of hypoglycemia diagnosis by FreeStyle Libre continuous glucose monitoring in long-term care home residents with diabetes. J Diabetes Sci Technol 2018; 12 (03) 727-728
  • 53 Gehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in type 2 diabetes–more common than you think: a continuous glucose monitoring study. J Diabetes Sci Technol 2015; 9 (05) 999-1005