{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T00:05:30Z","timestamp":1776816330264,"version":"3.51.2"},"reference-count":57,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2023,5,23]],"date-time":"2023-05-23T00:00:00Z","timestamp":1684800000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Qatar National Research Fund","award":["NPRP 11S-0110-180247"],"award-info":[{"award-number":["NPRP 11S-0110-180247"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Sensors"],"abstract":"<jats:p>Glucose monitoring is key to the management of diabetes mellitus to maintain optimal glucose control whilst avoiding hypoglycemia. Non-invasive continuous glucose monitoring techniques have evolved considerably to replace finger prick testing, but still require sensor insertion. Physiological variables, such as heart rate and pulse pressure, change with blood glucose, especially during hypoglycemia, and could be used to predict hypoglycemia. To validate this approach, clinical studies that contemporaneously acquire physiological and continuous glucose variables are required. In this work, we provide insights from a clinical study undertaken to study the relationship between physiological variables obtained from a number of wearables and glucose levels. The clinical study included three screening tests to assess neuropathy and acquired data using wearable devices from 60 participants for four days. We highlight the challenges and provide recommendations to mitigate issues that may impact the validity of data capture to enable a valid interpretation of the outcomes.<\/jats:p>","DOI":"10.3390\/s23115003","type":"journal-article","created":{"date-parts":[[2023,5,23]],"date-time":"2023-05-23T09:13:50Z","timestamp":1684833230000},"page":"5003","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Longitudinal Studies of Wearables in Patients with Diabetes: Key Issues and Solutions"],"prefix":"10.3390","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6062-5833","authenticated-orcid":false,"given":"Ahmad Yaser","family":"Alhaddad","sequence":"first","affiliation":[{"name":"Department of Mechanical and Industrial Engineering, Qatar University, Doha 2713, Qatar"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2384-6343","authenticated-orcid":false,"given":"Hussein","family":"Aly","sequence":"additional","affiliation":[{"name":"KINDI Center for Computing Research, Qatar University, Doha 2713, Qatar"}]},{"given":"Hoda","family":"Gad","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine\u2014Qatar, Doha 24144, Qatar"}]},{"given":"Einas","family":"Elgassim","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine\u2014Qatar, Doha 24144, Qatar"}]},{"given":"Ibrahim","family":"Mohammed","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine\u2014Qatar, Doha 24144, Qatar"},{"name":"Department of Internal Medicine, Albany Medical Center Hospital, Albany, NY 12208, USA"}]},{"given":"Khaled","family":"Baagar","sequence":"additional","affiliation":[{"name":"Hamad Medical Corporation, Doha 3050, Qatar"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0006-2642","authenticated-orcid":false,"given":"Abdulaziz","family":"Al-Ali","sequence":"additional","affiliation":[{"name":"KINDI Center for Computing Research, Qatar University, Doha 2713, Qatar"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2730-6483","authenticated-orcid":false,"given":"Kishor Kumar","family":"Sadasivuni","sequence":"additional","affiliation":[{"name":"Center for Advanced Materials, Qatar University, Doha 2713, Qatar"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5892-743X","authenticated-orcid":false,"given":"John-John","family":"Cabibihan","sequence":"additional","affiliation":[{"name":"Department of Mechanical and Industrial Engineering, Qatar University, Doha 2713, Qatar"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7188-8903","authenticated-orcid":false,"given":"Rayaz A.","family":"Malik","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine\u2014Qatar, Doha 24144, Qatar"}]}],"member":"1968","published-online":{"date-parts":[[2023,5,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1242","DOI":"10.1109\/TBME.2018.2871638","article-title":"Wearable Devices for Precision Medicine and Health State Monitoring","volume":"66","author":"Jeong","year":"2019","journal-title":"IEEE Trans. Biomed. Eng."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2573","DOI":"10.1109\/COMST.2017.2731979","article-title":"A Survey of Wearable Devices and Challenges","volume":"19","author":"Seneviratne","year":"2017","journal-title":"IEEE Commun. Surv. Tutor."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Piwek, L., Ellis, D.A., Andrews, S., and Joinson, A. (2016). The rise of consumer health wearables: Promises and barriers. PLoS Med., 13.","DOI":"10.1371\/journal.pmed.1001953"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Olmedo-Aguirre, J.O., Reyes-Campos, J., Alor-Hern\u00e1ndez, G., Machorro-Cano, I., Rodr\u00edguez-Mazahua, L., and S\u00e1nchez-Cervantes, J.L. (2022). Remote healthcare for elderly people using wearables: A review. Biosensors, 12.","DOI":"10.3390\/bios12020073"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"429","DOI":"10.2217\/pme-2018-0044","article-title":"Wearables and the medical revolution","volume":"15","author":"Dunn","year":"2018","journal-title":"Pers. Med."},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Alhaddad, A.Y., Cabibihan, J.J., and Bonarini, A. (2019, January 14\u201318). Recognition of aggressive interactions of children toward robotic toys. Proceedings of the 2019 28th IEEE International Conference on Robot and Human Interactive Communication (RO-MAN), Delhi, India.","DOI":"10.1109\/RO-MAN46459.2019.8956375"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1016\/j.cmpb.2017.10.008","article-title":"The usefulness and actual use of wearable devices among the elderly population","volume":"153","author":"Kekade","year":"2018","journal-title":"Comput. Methods Programs Biomed."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1279","DOI":"10.1007\/s12369-020-00626-z","article-title":"Influence of reaction time in the emotional response of a companion robot to a child\u2019s aggressive interaction","volume":"12","author":"Alhaddad","year":"2020","journal-title":"Int. J. Soc. Robot."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Cabibihan, J.J., Chellali, R., So, C.W.C., Aldosari, M., Connor, O., Alhaddad, A.Y., and Javed, H. (2018, January 28\u201330). Social robots and wearable sensors for mitigating meltdowns in autism\u2014A pilot test. Proceedings of the International Conference on Social Robotics, Qingdao, China.","DOI":"10.1007\/978-3-030-05204-1_11"},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Mamdiwar, S.D., Shakruwala, Z., Chadha, U., Srinivasan, K., and Chang, C.Y. (2021). Recent advances on IoT-assisted wearable sensor systems for healthcare monitoring. Biosensors, 11.","DOI":"10.3390\/bios11100372"},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Alban, A.Q., Ayesh, M., Alhaddad, A.Y., Al-Ali, A.K., So, W.C., Connor, O., and Cabibihan, J.J. (2021, January 8\u201312). Detection of challenging behaviours of children with autism using wearable sensors during interactions with social robots. Proceedings of the 2021 30th IEEE International Conference on Robot & Human Interactive Communication (RO-MAN), Vancouver, BC, Canada.","DOI":"10.1109\/RO-MAN50785.2021.9515459"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"e3449","DOI":"10.1002\/dmrr.3449","article-title":"Hypoglycaemia detection and prediction techniques: A systematic review on the latest developments","volume":"37","author":"Diouri","year":"2021","journal-title":"Diabetes\/Metab. Res. Rev."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"2239","DOI":"10.1016\/S0140-6736(17)30058-2","article-title":"Type 2 diabetes","volume":"389","author":"Chatterjee","year":"2017","journal-title":"Lancet"},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"American Diabetes Association (2021). Glycemic Targets: Standards of Medical Care in Diabetes\u20142021. Diabetes Care, 44, S73\u2013S84.","DOI":"10.2337\/dc21-S006"},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"American Diabetes Association (2021). Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes\u20142021. Diabetes Care, 44, S111\u2013S124.","DOI":"10.2337\/dc21-S009"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"e2633","DOI":"10.1002\/brb3.2633","article-title":"Fear of hypoglycemia\u2014An underestimated problem","volume":"12","author":"Przezak","year":"2022","journal-title":"Brain Behav."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1292","DOI":"10.1111\/dom.14339","article-title":"The comparative effects of intensive glucose lowering in diabetes patients aged below or above 65 years: Results from the ADVANCE trial","volume":"23","author":"Ohkuma","year":"2021","journal-title":"Diabetes Obesity Metab."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"699","DOI":"10.3389\/fbioe.2022.876672","article-title":"Sense and Learn: Recent Advances in Wearable Sensing and Machine Learning for Blood Glucose Monitoring and Trend-Detection","volume":"10","author":"Alhaddad","year":"2022","journal-title":"Front. Bioeng. Biotechnol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"919","DOI":"10.1177\/193229680800200526","article-title":"Finger Pricking and Pain: A Never Ending Story","volume":"2","author":"Heinemann","year":"2008","journal-title":"J. Diabetes Sci. Technol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1169","DOI":"10.1177\/1932296816631569","article-title":"Nonadjunctive Use of Continuous Glucose Monitoring for Diabetes Treatment Decisions","volume":"10","author":"Castle","year":"2016","journal-title":"J. Diabetes Sci. Technol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"108106","DOI":"10.1016\/j.jdiacomp.2021.108106","article-title":"Randomized comparison of self-monitored blood glucose (BGM) versus continuous glucose monitoring (CGM) data to optimize glucose control in type 2 diabetes","volume":"36","author":"Bergenstal","year":"2022","journal-title":"J. Diabetes Its Complicat."},{"key":"ref_22","doi-asserted-by":"crossref","unstructured":"Holzer, R., Bloch, W., and Brinkmann, C. (2022). Continuous glucose monitoring in healthy adults\u2014Possible applications in health care, wellness, and sports. Sensors, 22.","DOI":"10.3390\/s22052030"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"2411","DOI":"10.2337\/dc19-2213","article-title":"Long-term Cost-Effectiveness of Dexcom G6 Real-time Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Patients with Type 1 Diabetes in the U.K.","volume":"43","author":"Roze","year":"2020","journal-title":"Diabetes Care"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"e220352","DOI":"10.1530\/EC-22-0352","article-title":"Continuous glucose monitoring reveals a novel association between duration and severity of hypoglycemia, and small nerve fiber injury in patients with diabetes","volume":"11","author":"Gad","year":"2022","journal-title":"Endocr. Connect."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"103728","DOI":"10.1016\/j.jddst.2022.103728","article-title":"An overview of recent advances in insulin delivery and wearable technology for effective management of diabetes","volume":"75","author":"Raj","year":"2022","journal-title":"J. Drug Deliv. Sci. Technol."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1007\/s10916-021-01797-6","article-title":"Effectiveness of wearable device-based intervention on glycemic control in patients with type 2 diabetes: A system review and meta-analysis","volume":"46","author":"Luo","year":"2022","journal-title":"J. Med. Syst."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"689","DOI":"10.2337\/dc18-1843","article-title":"Early Detection of Hypoglycemia in Type 1 Diabetes Using Heart Rate Variability Measured by a Wearable Device","volume":"42","author":"Bekkink","year":"2019","journal-title":"Diabetes Care"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"787","DOI":"10.1088\/1361-6579\/aa5dd7","article-title":"Detection of atrial fibrillation episodes using a wristband device","volume":"38","author":"Corino","year":"2017","journal-title":"Physiol. Meas."},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Maritsch, M., F\u00f6ll, S., Lehmann, V., B\u00e9rub\u00e9, C., Kraus, M., Feuerriegel, S., Kowatsch, T., Z\u00fcger, T., Stettler, C., and Fleisch, E. (2020, January 25\u201330). Towards wearable-based hypoglycemia detection and warning in diabetes. Proceedings of the Extended Abstracts of the 2020 CHI Conference on Human Factors in Computing Systems, Honolulu, HI, USA.","DOI":"10.1145\/3334480.3382808"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1002\/cpt.966","article-title":"Wearable devices in clinical trials: Hype and hypothesis","volume":"104","author":"Izmailova","year":"2018","journal-title":"Clin. Pharmacol. Ther."},{"key":"ref_31","unstructured":"Hulley, S.B. (2007). Designing Clinical Research, Lippincott Williams & Wilkins."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1097\/00019442-200105000-00005","article-title":"Recruitment and retention of elderly patients in clinical trials: Issues and strategies","volume":"9","author":"Cassidy","year":"2001","journal-title":"Am. J. Geriatr. Psychiatry"},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1111\/j.1365-2702.2009.03041.x","article-title":"Clinical trials: The challenge of recruitment and retention of participants","volume":"19","author":"Gul","year":"2010","journal-title":"J. Clin. Nurs."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"515","DOI":"10.1016\/S0197-2456(01)00165-9","article-title":"Principles for enhanced recruitment of subjects in a large clinical trial: The XENDOS study experience","volume":"22","author":"Torgerson","year":"2001","journal-title":"Control. Clin. Trials"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"1233","DOI":"10.1001\/jama.297.11.1233","article-title":"Eligibility criteria of randomized controlled trials published in high-impact general medical journals: A systematic sampling review","volume":"297","author":"Toren","year":"2007","journal-title":"JAMA"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1016\/j.jbi.2009.12.004","article-title":"Formal representation of eligibility criteria: A literature review","volume":"43","author":"Weng","year":"2010","journal-title":"J. Biomed. Inform."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1177\/019384102236520","article-title":"Risks and wrongs in social science research: An evaluator\u2019s guide to the IRB","volume":"26","author":"Oakes","year":"2002","journal-title":"Eval. Rev."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1111\/j.1475-6773.2005.00458.x","article-title":"Impact of institutional review board practice variation on observational health services research","volume":"41","author":"Green","year":"2006","journal-title":"Health Serv. Res."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"176","DOI":"10.2146\/ajhp070066","article-title":"Working with the institutional review board","volume":"66","author":"Byerly","year":"2009","journal-title":"Am. J. Health-Syst. Pharm."},{"key":"ref_40","doi-asserted-by":"crossref","unstructured":"Friedman, L.M., Furberg, C.D., DeMets, D.L., Reboussin, D.M., and Granger, C.B. (2015). Fundamentals of Clinical Trials, Springer.","DOI":"10.1007\/978-3-319-18539-2"},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"621","DOI":"10.1007\/s12369-022-00889-8","article-title":"Real-time social robot\u2019s responses to undesired interactions between children and their surroundings","volume":"15","author":"Alhaddad","year":"2023","journal-title":"Int. J. Soc. Robot."},{"key":"ref_42","doi-asserted-by":"crossref","unstructured":"Janidarmian, M., Roshan Fekr, A., Radecka, K., and Zilic, Z. (2017). A comprehensive analysis on wearable acceleration sensors in human activity recognition. Sensors, 17.","DOI":"10.3390\/s17030529"},{"key":"ref_43","doi-asserted-by":"crossref","unstructured":"Alban, A.Q., Alhaddad, A.Y., Al-Ali, A., So, W.C., Connor, O., Ayesh, M., Ahmed Qidwai, U., and Cabibihan, J.J. (2023). Heart Rate as a Predictor of Challenging Behaviours among Children with Autism from Wearable Sensors in Social Robot Interactions. Robotics, 12.","DOI":"10.3390\/robotics12020055"},{"key":"ref_44","doi-asserted-by":"crossref","first-page":"406","DOI":"10.1089\/dia.2019.0048","article-title":"Predicting Nocturnal Hypoglycemia with Measures of Physical Activity Intensity in Adolescent Athletes with Type 1 Diabetes","volume":"21","author":"Jaggers","year":"2019","journal-title":"Diabetes Technol. Ther."},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1177\/1932296813516208","article-title":"The Impact of Accelerometer and Heart Rate Data on Hypoglycemia Mitigation in Type 1 Diabetes","volume":"8","author":"Stenerson","year":"2014","journal-title":"J. Diabetes Sci. Technol."},{"key":"ref_46","doi-asserted-by":"crossref","first-page":"975","DOI":"10.1016\/j.jdiacomp.2018.05.020","article-title":"Lower objectively measured physical activity is linked with perceived risk of hypoglycemia in type 1 diabetes","volume":"32","author":"Keshawarz","year":"2018","journal-title":"J. Diabetes Its Complicat."},{"key":"ref_47","doi-asserted-by":"crossref","first-page":"1594","DOI":"10.1111\/jdi.13313","article-title":"Corneal nerve loss in children with type 1 diabetes mellitus without retinopathy or microalbuminuria","volume":"11","author":"Gad","year":"2020","journal-title":"J. Diabetes Investig."},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1111\/jdi.13643","article-title":"Corneal confocal microscopy for the diagnosis of diabetic peripheral neuropathy: A systematic review and meta-analysis","volume":"13","author":"Gad","year":"2022","journal-title":"J. Diabetes Investig."},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"948","DOI":"10.1089\/dia.2013.0129","article-title":"Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction","volume":"15","author":"Casellini","year":"2013","journal-title":"Diabetes Technol. Ther."},{"key":"ref_50","unstructured":"Gamboa, H. (2008). Multi-Modal Behavioral Biometrics Based on HCI and Electrophysiology. [Ph.D. Thesis, Universidade T\u00e9cnica de Lisboa]."},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"1689","DOI":"10.3758\/s13428-020-01516-y","article-title":"NeuroKit2: A Python toolbox for neurophysiological signal processing","volume":"53","author":"Makowski","year":"2021","journal-title":"Behav. Res. Methods"},{"key":"ref_52","doi-asserted-by":"crossref","unstructured":"Elgendi, M., Norton, I., Brearley, M., Abbott, D., and Schuurmans, D. (2013). Systolic peak detection in acceleration photoplethysmograms measured from emergency responders in tropical conditions. PLoS ONE, 8.","DOI":"10.1371\/journal.pone.0076585"},{"key":"ref_53","first-page":"e215","article-title":"Brno University of Technology ECG Quality Database (BUT QDB)","volume":"101","author":"Nemcova","year":"2020","journal-title":"PhysioNet"},{"key":"ref_54","doi-asserted-by":"crossref","first-page":"727","DOI":"10.3389\/fphys.2018.00727","article-title":"SQI quality evaluation mechanism of single-lead ECG signal based on simple heuristic fusion and fuzzy comprehensive evaluation","volume":"9","author":"Zhao","year":"2018","journal-title":"Front. Physiol."},{"key":"ref_55","first-page":"278","article-title":"Challenges of recruitment and retention of university students as research participants: Lessons learned from a pilot study","volume":"67","year":"2018","journal-title":"J. Aust. Libr. Inf. Assoc."},{"key":"ref_56","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1186\/1471-2288-14-10","article-title":"Factors influencing recruitment to research: Qualitative study of the experiences and perceptions of research teams","volume":"14","author":"Newington","year":"2014","journal-title":"BMC Med. Res. Methodol."},{"key":"ref_57","first-page":"343","article-title":"Strategies for dealing with missing data in clinical trials: From design to analysis","volume":"86","author":"Dziura","year":"2013","journal-title":"Yale J. Biol. Med."}],"container-title":["Sensors"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8220\/23\/11\/5003\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T19:40:25Z","timestamp":1760125225000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8220\/23\/11\/5003"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5,23]]},"references-count":57,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2023,6]]}},"alternative-id":["s23115003"],"URL":"https:\/\/doi.org\/10.3390\/s23115003","relation":{},"ISSN":["1424-8220"],"issn-type":[{"value":"1424-8220","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,5,23]]}}}