TY - JOUR

T1 - ‘Is Insulin Right for Me?’

T2 - Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes—A randomised controlled trial

AU - Holmes-Truscott, Elizabeth

AU - Holloway, Edith E.

AU - Lam, Benjamin

AU - Baptista, Shaira

AU - Furler, John

AU - Hagger, Virginia

AU - Skinner, Timothy

AU - Speight, Jane

N1 - Funding Information: This investigator‐sponsored study was supported by funding from Sanofi, Australia. Sanofi was not involved in the design, collection, analysis, interpretation or reporting of the study, but was given the opportunity to review the manuscript prior to submission. The decision to submit for publication was made independently by the authors. Sanofi will be allowed access to all de‐identified data from the study for research and audit purposes, if requested. In‐kind support including project oversight was provided by the Investigator team. EHT and JS are supported by the core funding to the Australian Centre for Behavioural Research in Diabetes (ACBRD) provided by the collaboration between Diabetes Victoria and Deakin University. EEH, SB and BL were supported, in part, by an unrestricted grant from Diabetes Australia. Costs associated with participation incentives, website development and data management were funded (fully or partially) by the ACBRD. Publisher Copyright: © 2023 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

PY - 2023

Y1 - 2023

N2 - Aims: To test ‘Is Insulin Right for Me?’, a theory-informed, self-directed, web-based intervention designed to reduce psychological barriers to insulin therapy among adults with type 2 diabetes. Further, to examine resource engagement and associations between minimum engagement and outcomes. Methods: Double-blind, two-arm randomised controlled trial (1:1), comparing the intervention with freely available online information (control). Eligible participants were Australian adults with type 2 diabetes, taking oral diabetes medications, recruited primarily via national diabetes registry. Exclusion criteria: prior use of injectable medicines; being ‘very willing’ to commence insulin. Data collections were completed online at baseline, 2-week and 6-month follow-up. Primary outcome: negative insulin treatment appraisal scale (ITAS) scores; secondary outcomes: positive ITAS scores and hypothetical willingness to start insulin. Analyses: intention-to-treat (ITT); per-protocol (PP) examination of outcomes by engagement. Trial registration: ACTRN12621000191897. Results: No significant ITT between-arm (intervention: n = 233; control: n = 243) differences were observed in primary (2 weeks: Mdiff [95% CI]: −1.0 [−2.9 to 0.9]; 6 months: −0.01 [−1.9 to 1.9]), or secondary outcomes at either follow-up. There was evidence of lower Negative ITAS scores at 2-week, but not 6-month, follow-up among those with minimum intervention engagement (achieved by 44%) compared to no engagement (−2.7 [−5.1 to −0.3]). Conclusions: Compared to existing information, ‘Is insulin right for me?’ did not improve outcomes at either timepoint. Small intervention engagement effects suggest it has potential. Further research is warranted to examine whether effectiveness would be greater in a clinical setting, following timely referral among those for whom insulin is clinically indicated.

AB - Aims: To test ‘Is Insulin Right for Me?’, a theory-informed, self-directed, web-based intervention designed to reduce psychological barriers to insulin therapy among adults with type 2 diabetes. Further, to examine resource engagement and associations between minimum engagement and outcomes. Methods: Double-blind, two-arm randomised controlled trial (1:1), comparing the intervention with freely available online information (control). Eligible participants were Australian adults with type 2 diabetes, taking oral diabetes medications, recruited primarily via national diabetes registry. Exclusion criteria: prior use of injectable medicines; being ‘very willing’ to commence insulin. Data collections were completed online at baseline, 2-week and 6-month follow-up. Primary outcome: negative insulin treatment appraisal scale (ITAS) scores; secondary outcomes: positive ITAS scores and hypothetical willingness to start insulin. Analyses: intention-to-treat (ITT); per-protocol (PP) examination of outcomes by engagement. Trial registration: ACTRN12621000191897. Results: No significant ITT between-arm (intervention: n = 233; control: n = 243) differences were observed in primary (2 weeks: Mdiff [95% CI]: −1.0 [−2.9 to 0.9]; 6 months: −0.01 [−1.9 to 1.9]), or secondary outcomes at either follow-up. There was evidence of lower Negative ITAS scores at 2-week, but not 6-month, follow-up among those with minimum intervention engagement (achieved by 44%) compared to no engagement (−2.7 [−5.1 to −0.3]). Conclusions: Compared to existing information, ‘Is insulin right for me?’ did not improve outcomes at either timepoint. Small intervention engagement effects suggest it has potential. Further research is warranted to examine whether effectiveness would be greater in a clinical setting, following timely referral among those for whom insulin is clinically indicated.

KW - attitudes

KW - insulin

KW - intervention

KW - psychological insulin resistance

KW - randomised control trial

KW - type 2 diabetes

U2 - 10.1111/dme.15117

DO - 10.1111/dme.15117

M3 - Journal article

C2 - 37052584

AN - SCOPUS:85153613831

VL - 40

JO - Diabetic Medicine Online

JF - Diabetic Medicine Online

SN - 1464-5491

IS - 7

M1 - e15117

ER -