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

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);

Application of Telemedicine in Diabetes Care: The Time is Now

“…This approach may avoid the need for diabetes-related unscheduled patient presentations to practitioners, emergency rooms, or hospitalizations. One of these systems, incorporating a basal algorithm and a basal plus insulin algorithm, was tested within a proof-of-concept study on patients with type 2 diabetes who were receiving domiciliary nursing care under routine conditions [ 23 ]. Preliminary results showed that admissions to the hospital due to hypo- or hyperglycemic derailment is substantially reduced while glycemic control is improved by using this system.…”

Digital algorithm-guided insulin therapy in home healthcare for elderly persons with type 2 diabetes: A proof-of-concept study

“…If participants also received basal-plus insulin therapy, the bolus insulin component was estimated initially with 20% of the basal insulin dose. If necessary, investigators were contacted and reviewed the suggestion for correctness and plausibility ( 17 ).…”

“…Second: Support in performing the subcutaneous basal insulin therapy, especially tailored to participants, by providing a) insulin dose recommendations for an initial basal insulin dose and basal insulin titration support based on previous BG values and insulin doses. An authorized healthcare professional must confirm the suggested insulin dose in regular intervals, b) workflow support for varying intensity of BG measurements (full daily profile during therapy initialisation phase versus fasting values only for ongoing therapy), c) workflow support and dose calculation for basal-plus therapy which means administration of a short-acting insulin together with a defined meal ( 17 ).…”

Clinical Decision Support for Diabetes Care in the Hospital: A Time for Change Toward Improvement of Management and Outcomes

“…Proof of concept for the investigation of efficacy, safety, and user’s acceptance of decision support in ambulatory participants receiving home health care is undergoing. 24 More evidence is needed to determine whether CDS for diabetes in the ambulatory setting influences rates of hospitalization or glycemic control achieved during hospital stays.…”