Satisfaction with the Use of Different Technologies for Insulin Delivery and Glucose Monitoring Among Adults with Long-Standing Type 1 Diabetes and Problematic Hypoglycemia: 2-Year Follow-Up in the HypoCOMPaSS Randomized Clinical Trial
Publication: Diabetes Technology & Therapeutics
Volume 21, Issue Number 11
Abstract
Background: In the HypoCOMPaSS trial, adults with long-standing type 1 diabetes and problematic hypoglycemia were randomized to compare insulin pump (continuous subcutaneous insulin infusion; CSII) with multiple daily injections (MDI) and real-time continuous glucose monitoring (RT-CGM) with conventional self-monitoring of blood glucose (SMBG). Our aim was to investigate participants' satisfaction with these technologies at 6-month randomized, controlled trial (RCT) endpoint and at 2-year follow-up.
Methods: Participants completed the Insulin Treatment Satisfaction Questionnaire subscales “device delivery” and “hypoglycemia control”; and Glucose Monitoring Experience Questionnaire, assessing “convenience”, “effectiveness”, “intrusiveness”, and “total satisfaction.” We assessed change over time and between-group differences by insulin and monitoring modalities.
Results: Participants (N = 96) were 64% women, aged 49 ± 12 years, with a diabetes duration of 29 ± 12 years. At 6 months, participants reported improvements compared with baseline (all P < 0.001) in satisfaction with insulin “delivery device” (r = 0.39) and “hypoglycemia control” (r = 0.52), and trends toward significance in perceived “effectiveness” (r = 0.42) and “intrusiveness” (r = 0.27) of monitoring device (but not “convenience”, P = 0.139). All improvements were sustained at 2 years. At 6 months, the only difference between arms was that greater satisfaction with insulin “delivery device” was reported in the CSII group compared with MDI (P < 0.001, r = 0.40). No between-group differences were observed at 2 years.
Conclusions: Overall, significant improvements in participant satisfaction with diabetes technologies were observed over the 6-month RCT, in all domains except “convenience,” and maintained at 2 years. Although HypoCOMPaSS demonstrated noninferiority of SMBG versus CGM, and MDI versus CSII in terms of biomedical outcomes, detailed assessments confirm that participants' satisfaction with delivery device was greater in those allocated to CSII than MDI.
Get full access to this article
View all available purchase options and get full access to this article.
References
1. Little S, Leelarathna L, Barendse S, et al.: Severe hypoglycaemia in type 1 diabetes mellitus: underlying drivers and potential strategies for successful prevention. Diabetes Metab Res Rev 2014;30:175–190.
2. Little SA, Leelarathna L, Walkinshaw E, et al.: Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care 2014;37:2114–2122.
3. Little SA, Speight J, Leelarathna L, et al.: Sustained reduction in severe hypoglycemia in adults with type 1 diabetes complicated by impaired awareness of hypoglycemia: two-year follow-up in the HypoCOMPaSS randomized clinical trial. Diabetes Care 2018;41:1600–1607.
4. Little S, Chadwick T, Choudhary P, et al.: Comparison of optimised MDI versus pumps with or without sensors in severe hypoglycaemia (the Hypo COMPaSS trial). BMC Endocr Disord 2012;12:33.
5. Bradley C: The Diabetes Treatment Satisfaction Questionnaire (DTSQ). In: Bradley C, ed. Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Research and Practice. Chur, Switzerland: Harwood Academic, 1994.
6. Speight J, Holmes-Truscott E, Singh H, Little S, Shaw JAM. Development and psychometric validation of the novel Glucose Monitoring Experiences Questionnaire (GME-Q) among adults with type 1 diabetes. Diabetes Technol Ther.
7. Anderson RT, Skovlund SE, Marrero D, et al.: Development and validation of the insulin treatment satisfaction questionnaire. Clin Ther 2004;26:565–578.
8. Yeh H-C, Brown T, Maruthar N, et al.: Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med 2012;154:336–347.
9. Barnard K, Lloyd C, Skinner T: Systematic literature review: quality of life associated with insulin pump use in type 1 diabetes. Diabet Med 2007;24:607–617.
10. The REPOSE Study Group: Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE). BMJ 2017;356:j1285.
11. Lind M, Polonsky W, Hirsch IB, et al.: Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the GOLD randomized clinical trial. JAMA 2017;317:379–387.
12. Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, et al.: Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia 2018;61:539–550.
13. Hommel E, Olsen B, Battelino T, et al.: Impact of continuous glucose monitoring on quality of life, treatment satisfaction, and use of medical care resources: analyses from the SWITCH study. Acta Diabetol 2014;51:845–851.
14. Shikiar R, Rentz A: Satisfaction with medication: an overview of conceptual, methodologic, and regulatory issues. Value Health 2004;7:204–215.
15. Vaddiraju S, Burgess DJ, Tomazos I, Jain FC, Papadimitrakopoulos F: Technologies for continuous glucose monitoring: current problems and future promises. J Diabetes Sci Technol 2010;4:1540–1562.
16. Gonder-Frederick LA, Shepard JA, Grabman JH, Ritterband LM: Psychology, technology, and diabetes management. Am Psychol 2016;71:577–589.
17. Choudhary P, Rickels MR, Senior PA, et al.: Evidence-informed clinical practice recommendations for treatment of type 1 diabetes complicated by problematic hypoglycemia. Diabetes Care 2015;38:1016–1029.
Information & Authors
Information
Published In
Diabetes Technology & Therapeutics
Volume 21 • Issue Number 11 • November 2019
Pages: 619 - 626
PubMed: 31335201
Copyright
Copyright 2019, Mary Ann Liebert, Inc., publishers.
History
Published in print: November 2019
Published online: 21 October 2019
Published ahead of print: 9 October 2019
Published ahead of production: 23 July 2019
Topics
Authors
Authors' Contributions
The HypoCOMPaSS Study was led by J.A.M.S., M.L.E., D.F., S.R.H., D.K. and J.S. J.S. and J.A.M.S. determined the psychological measures to be included in the HypoCOMPaSS survey booklet, in liaison with the investigator team. J.S., E.H.T. and J.A.M.S. developed the plan for this study. E.H.T. prepared the psychological dataset and conducted statistical analyses. J.S. and E.H.T. prepared the first draft, with input from J.A.M.S. All other authors reviewed the draft and provided critical input. All authors approve the final version.
Author Disclosure Statement
J.S. has participated in advisory boards for Medtronic, Roche Diabetes Care and Sanofi Diabetes; her research center (ACBRD) has honoraria in respect of these activities, as well as unrestricted educational grants from Abbott Diabetes Care, AstraZeneca and Sanofi Diabetes; in-kind support (products and consumables) for studies from Abbott Diabetes Care, Medtronic, Roche Diabetes Care and Sanofi Diabetes; speaker fees from Astra Zeneca, Medtronic, Novo Nordisk, Roche Diabetes Care and Sanofi Diabetes; sponsorship to attend educational meetings; and consultancy income from Roche Diabetes Care and Sanofi Diabetes. J.S. is a director of AHP Research Ltd that owns the copyright of the GME-Q. E.H.T. has participated in an advisory board for Astra Zeneca, has received unrestricted educational grants from Abbott Diabetes Care and Sanofi Diabetes, and speaker fees from Novo Nordisk; her research has received in-kind support (products and consumables) for studies from Abbott Diabetes Care and Roche Diabetes Care. M.L.E. has received travel support from Medtronic, Roche, and Novo Nordisk, speaker fees from Novo Nordisk, Eli Lilly, Astra Zeneca, and Abbott Diabetes Care, has received research support from Boehringer Ingelheim, Novo Nordisk, MedImmune, Imcyse, NGM Pharma, and Medtronic, and has been on advisory boards for CellNovo, Medtronic, Abbott Diabetes Care, Dexcom, and Roche. D.F. has received speaker's fees from Animas and Novo Nordisk. D.K. has received honoraria for participation in educational events and consultancy fees from Novo Nordisk, Sanofi, and Ascensia. He is also medical advisor to Glooko and has received research support from Lilly. S.R.H. has carried out consultancy work for device and insulin companies: Sanofi, Novo Nordisk, and Eli Lilly and Company, Boehringer Ingelheim, received research support from Medtronic, and speaker fees from Novo Nordisk, Eli Lilly and Company, and Astra Zeneca. J.A.M.S. has previously participated in advisory boards for Medtronic and received travel support for conference attendance from Novo Nordisk, and Sanofi. No other potential conflicts of interest relevant to this article were reported.
Metrics & Citations
Metrics
Citations
Export Citation
Export citation
Select the format you want to export the citations of this publication.
View Options
Get Access
Access content
To read the fulltext, please use one of the options below to sign in or purchase access.⚠ Society Access
If you are a member of a society that has access to this content please log in via your society website and then return to this publication.