Katharine Barnard-Kelly, United Kingdom

BHR Ltd R&D

Presenter of 4 Presentations

ORAL PRESENTATION SESSION

PATIENT REPORTED PREFERENCES FROM THE PRO SOLO: NOVEL PATCH PUMP CLINICAL TRIAL

Abstract

Background and Aims

Patch pumps have become a relevant alternative to classic tethered (tubed) insulin pumps. Patient Reported Outcomes (PROs) play a vital role in understanding the ability/willingness of individuals to engage with such systems. We aimed to investigate the preferences of participants using the novel AccuChek Solo (ACS) pump.

Methods

Participants with T1D naïve to insulin pump therapy (39.0 ±11.9 years, 44% female, 15.0±10.8 duration of diabetes, HbA1c 8.0 ± 0.6% (70.5 mmol/mol) enrolled in a multinational RCT were asked to provide feedback on the ACS pump. Participants were either ACS direct users or switched from MDI six months into the study.

Results

Benefits of ACS were reported by n=180 participants (n=133 ACS direct use, n=47 MDI switchers), providing n=226 individual coded responses. Most cited benefits: wireless (n=37), quick bolus (n=32), no injections (n=28), bolus calculator, ease of use and discretion (all n=22). Most useful attributes reported by n=166 participants (n=166 individual responses): bolus calculator (n=64), flexible basal/bolus rates (n=42) and quick bolus function (n=41). Downsides were reported by n=166 participants (n=216 individual responses): manager not a smartphone app (n=57), not waterproof (n=39) and needs greater compatibility with other systems eg flash/CGM/BG meter (n=26)

Conclusions

Users overwhelmingly found the bolus calculator/device manager most useful and benefitted from the wireless, discreet nature of the system. Integration of the manager into a smartphone was recommended by most and a waterproof version desirable by many. Results indicate ACS is an acceptable therapy choice with potential to improve biomedical and psychosocial outcomes of users.

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ORAL PRESENTATION SESSION

SPOTLIGHT CONSULTATIONS: ILLUMINATING PATIENT PRIORITIES – T1 DIABETES

Abstract

Background and Aims

Burnout in people with diabetes and healthcare professionals is at an all-time high. Spotlight is a novel ‘smart’ adaptive dynamic patient questionnaire designed to improve routine outpatient consultations by rapidly identifying patient priorities and presenting these in the context of personalised areas for concern and best-practice care pathways to illuminate consultations. We assessed the feasibility of using Spotlight in routine care.

Methods

The Spotlight prototype tool was trialled at three centres (two primary care, one specialist) between June-September 2020.

Results

Thirty-one adults with T1D (n=13 male; n=18 female) participated in this real-world evidence collection, each identifying two priority concerns. ‘Psychological burden of diabetes’ was the most common primary concern (n=27,87.1%) followed by ‘gaining more skills about particular aspects of diabetes’ (n=19,61.3%), ‘improving support around me’ (n=8,25.8%) and ‘diabetes-related treatment issues’ (n=8,25.8%). Burden of diabetes was widespread as was lack of confidence around self-management. Participants with diabetes-related complications more often prioritised "diabetes related treatment issues" than those without complications. People whose last HbA1c was ≥ 8.6% were more likely to prioritise "gaining more skills" than those whose A1c was ≤ 8.5. Men reported greater psychological burden (92.3%-v-83.3%) whilst women prioritised gaining more skills (66.7%-v-53.9%). Those aged <35 years more often prioritised psychological burden than those ≥35 years (100%-v-82.6%). Gaining more skills was more frequently a priority concern among those with higher duration of diabetes (44% among <10 years vs. 68% among >10 years).

Conclusions

Spotlight is acceptable and feasible used in routine care. It is effective in identifying biomedical and psychological priorites of patients.

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PARALLEL SESSION

Presentation of key instruments and how to use them (INSPIRE measures)

Abstract

Abstract Body

Aim: Diabetes technologies come with benefits and burdens that affect their uptake and continued use. The aim of the INSPIRE measures is to capture the psychosocial aspects of automated insulin dosing systems for youth, parents, adults and partners living with type 1 diabetes.

Methods: An extensive mixed-methods investigation consisting of interviews, focus groups, cognitive debriefing and questionnaire completion was conducted across centres in the USA and UK. To validate the measures, data from 292 youth, 159 adults, 150 parents of youth and 149 partners of individuals recruited from the Type 1 Diabetes Exchange Registry were analysed. Participants completed INSPIRE questionnaires and measures of quality of life, fear of hypoglycaemia, diabetes distress, glucose monitoring satisfaction. Exploratory factor analysis assessed factor structures. Associations between INSPIRE scores and other measures, HbA1c, and technology use assessed concurrent and discriminant validity.

Results: Four brief self-report measures were completed and successfully qualified through the FDA MDDT process. Youth, adult, parent and partner measures assess psychosocial aspects of automated insulin delivery systems and provide opportunity for consistent assessment across clinical trials globally. Measures range from 17 to 22 items, are available in several languages and are reliable (a=0.95–0.97). Use of the INSPIRE measures in clinical research will be discussed in terms of evaluation and reporting of PROs.

Conclusions: INSPIRE measures assessing the psychosocial aspects of automated insulin dosing systems for youth, adults, parents and partners have meaningful factor structures and are internally consistent. The developmentally-sensitive INSPIRE measures offer added value both within clinical trials and clinical practice.

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Moderator of 1 Session

PARALLEL SESSION
Date
Fri, 04.06.2021
Session Type
PARALLEL SESSION
Session Time
20:10 - 21:40
Room
Hall C