Table 2 Study outcomes
Primary feasibility outcomes | |
Acceptability of Omnipod DASH® System vs. usual care | Difference in Diabetes Technology Questionnaire ‘current’ (DTQ-current) score between baseline and 12 weeks post-randomisation in that proportion of participants who complete the study |
Secondary feasibility outcomes | |
User acceptance | Diabetes technology treatment satisfaction: a) DTQ ‘current’ at 24 weeks post-randomisation b) DTQ ‘change’ at 12 and 24 weeks post-randomisation |
Process outcomes | a) Recruitment and retention rates b) Frequency of additional study visits required c) Clarity of the inclusion and exclusion criteria as assessed feedback from the trial teams |
Resource outcomes | a) Time taken for study procedures (e.g. education on the use of Omnipod DASH® System) b) Mode of interaction (face-to-face vs. virtual) c) Device-related outcomes i. Length of time taken to change Omnipod DASH® pods vs. insulin pump infusion sets (for participants on IPT) ii. Length of time taken to upload Omnipod DASH® PDM data vs. pump data (for participants on IPT) iii. Frequency of Omnipod DASH® pod failures vs. insulin infusion line occlusions (for participants on IPT) Pre-defined as: • Unexplained finger-prick glucose reading > 14 mmol/L that does not respond to a corrective dose of insulin with ≥ 2.8 mmol/L drop within one hour • Finger-prick glucose reading > 14 mmol/L with elevated ketones ≥ 0.6 mmol/L • Occurrence of a non-resolvable pump occlusion/failure alarm) |
Secondary scientific outcomes | |
Participant-centred outcomes | Questionnaires: a) Diabetes distress: Problem Areas in Diabetes (PAID) questionnaire b) Sleep quality: Pittsburgh Sleep Quality Index (PSQI) c) Fear of hypoglycaemia: Hypoglycaemia Fear Survey Short-Form (HFS-II-SF) d) Diabetes treatment satisfaction: Diabetes Medication System Rating Questionnaire Short-Form (DMSRQ-SF) e) User satisfaction: User Evaluation Questionnaire (UEQ) f) Treatment system efficacy and effectiveness: System Usability Scale (SUS) |
Participant perceptions of Omnipod DASH® System assessed via semi-structured interviews | |
Healthcare professional perspectives | Healthcare professional perceptions of Omnipod DASH® System assessed via semi-structured interviews |
Glycaemic outcomes | Masked CGM metrics a) Percentage of time spent < 2.8 mmol/L b) Percentage of time spent < 3.3 mmol/L c) Percentage of time spent < 3.9 mmol/L d) Percentage of time spent 3.9–7.8 mmol/L e) Percentage of time spent 3.9–10 mmol/L f) Percentage of time spent > 10.0 mmol/L g) Percentage of time spent > 13.9 mmol/L h) Percentage of time spent > 16.7 mmol/L i) Standard deviation and coefficient of variation of CGM j) Mean CGM glucose |
HbA1c | |
Symptomatic hypoglycaemic events recorded in real time through KeyLead Health™ phone application Defined as typical symptoms of hypoglycaemia with finger-prick glucose reading < 3.9 mmol/L | |