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      Study protocol for assessing the user acceptance, safety and efficacy of a tablet-based workflow and decision support system with incorporated basal insulin algorithm for glycaemic management in participants with type 2 diabetes receiving home health care: A single-centre, open-label, uncontrolled proof-of-concept study

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          Abstract

          Introduction

          Diabetes management can be especially complex for older adults who receive health care at home. Thus, international guidelines recommend basal-insulin regimens due to simpler handling and low hypoglycaemia risk. A basal-insulin algorithm (including basal-plus) was developed to also include participant's health status and subsequently implemented into a tablet-based workflow and decision support system, GlucoTab@MobileCare. This study protocol describes a proof-of-concept study to investigate user acceptance, safety and efficacy of the GlucoTab@MobileCare system in participants receiving home health care.

          Methods

          The open-label, single-centre, uncontrolled study will recruit a maximum of ten participants with insulin treated type-2-diabetes (age ≥18 years) who receive home health care. During a three month study period participants will receive basal- or basal-plus-insulin therapy once daily as suggested by the GlucoTab@MobileCare system. Statistical analysis will be conducted on an intention-to-treat basis. The primary endpoint is the percentage of tasks (BG measurements, insulin dose calculations, insulin injections) that were performed according to GlucoTab@MobileCare suggestions relative to the total of suggested tasks. Secondary endpoints include user acceptance, safety and efficacy parameters. The study was approved by the ethics committee and regulatory authorities. Before obtaining written informed consent, all participants will receive oral and written information about all aspects of the study. Results will be published in a peer-reviewed journal and at diabetes and geriatric conferences.

          Discussion

          Potential implications may be improved quality and safety of basal-insulin therapy in older adults as well as support for health-care-providers in daily routine including evidence-based knowledge.

          Trial registration

          German Clinical Trials Register (DRKS00015059);

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          Most cited references17

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          Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence

          Background People with diabetes can suffer from diverse complications that seriously erode quality of life. Diabetes, costing the United States more than $174 billion per year in 2007, is expected to take an increasingly large financial toll in subsequent years. Accurate projections of diabetes burden are essential to policymakers planning for future health care needs and costs. Methods Using data on prediabetes and diabetes prevalence in the United States, forecasted incidence, and current US Census projections of mortality and migration, the authors constructed a series of dynamic models employing systems of difference equations to project the future burden of diabetes among US adults. A three-state model partitions the US population into no diabetes, undiagnosed diabetes, and diagnosed diabetes. A four-state model divides the state of "no diabetes" into high-risk (prediabetes) and low-risk (normal glucose) states. A five-state model incorporates an intervention designed to prevent or delay diabetes in adults at high risk. Results The authors project that annual diagnosed diabetes incidence (new cases) will increase from about 8 cases per 1,000 in 2008 to about 15 in 2050. Assuming low incidence and relatively high diabetes mortality, total diabetes prevalence (diagnosed and undiagnosed cases) is projected to increase from 14% in 2010 to 21% of the US adult population by 2050. However, if recent increases in diabetes incidence continue and diabetes mortality is relatively low, prevalence will increase to 33% by 2050. A middle-ground scenario projects a prevalence of 25% to 28% by 2050. Intervention can reduce, but not eliminate, increases in diabetes prevalence. Conclusions These projected increases are largely attributable to the aging of the US population, increasing numbers of members of higher-risk minority groups in the population, and people with diabetes living longer. Effective strategies will need to be undertaken to moderate the impact of these factors on national diabetes burden. Our analysis suggests that widespread implementation of reasonably effective preventive interventions focused on high-risk subgroups of the population can considerably reduce, but not eliminate, future increases in diabetes prevalence.
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            Diabetes mellitus in older people: position statement on behalf of the International Association of Gerontology and Geriatrics (IAGG), the European Diabetes Working Party for Older People (EDWPOP), and the International Task Force of Experts in Diabetes.

            Diabetes mellitus is a highly prevalent metabolic condition in ageing societies associated with high levels of morbidity, multiple therapies, and functional deterioration that challenges even the best of health care systems to deliver high-quality, individualized care. Most international clinical guidelines have ignored the often-unique issues of frailty, functional limitation, changes in mental health, and increasing dependency that characterize many aged patients with diabetes. A collaborative Expert Group of the IAGG and EDWPOP and an International Task Force have explored the key issues that affect diabetes in older people using a robust method comprising a Delphi process and an evidence-based review of the literature. Eight domains of interest were initially agreed and discussed: hypoglycemia, therapy, care home diabetes, influence of comorbidities, glucose targets, family/carer perspectives, diabetes education, and patient safety. A set of "consensus" statements was produced in each domain of interest. These form a foundation for future policy development in this area and should influence the clinical behavior and approach of all health professionals engaged in delivering diabetes care to older people. Copyright © 2012 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.
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              Diabetes in older people: new insights and remaining challenges.

              Diabetes in ageing communities imposes a substantial personal and public health burden by virtue of its high prevalence, its capacity to cause disabling vascular complications, the emergence of new non-vascular complications, and the effects of frailty. In this Review, we examine the current state of knowledge about diabetes in older people (aged ≥ 75 years) and discuss how recognition of the effect of frailty and disability is beginning to lead to new management approaches. A multidimensional and multidisciplinary assessment process is essential to obtain information on medical, psychosocial, and functional capabilities, and also on how impairments of these functions could limit activities. Major aims of diabetes care include maintenance of independence, functional status, and quality of life by reduction of symptom and medicine burden, and active identification of risks. Linking of therapeutic targets to individual functional status is mandatory and very tight glucose control is often not necessary. Hypoglycaemia remains an important avoidable iatrogenic event. Quality diabetes care in older people remains an important challenge for health professionals.
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                Author and article information

                Contributors
                Journal
                Contemp Clin Trials Commun
                Contemp Clin Trials Commun
                Contemporary Clinical Trials Communications
                Elsevier
                2451-8654
                17 July 2020
                September 2020
                17 July 2020
                : 19
                : 100620
                Affiliations
                [a ]Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria
                [b ]JOANNEUM RESEARCH Forschungsgesellschaft mbH, HEALTH, Institute for Biomedicine and Health Sciences, Graz, Austria
                [c ]AUSTRIAN RED CROSS, Landesverband Steiermark, Graz, Austria
                Author notes
                []Corresponding author. Stiftingtalstraße 24, 8010, Graz, Austria katharina.lichtenegger@ 123456medunigraz.at
                [1]

                should be considered joint first author.

                Article
                S2451-8654(20)30104-6 100620
                10.1016/j.conctc.2020.100620
                7399114
                fd6736ce-d831-4ae6-9cce-660bcba3b6fd
                © 2020 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 10 February 2020
                : 22 June 2020
                : 12 July 2020
                Categories
                Article

                clinical trials,elderly,devices,insulin therapy,diabetes
                clinical trials, elderly, devices, insulin therapy, diabetes

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