HypoCOMPaSS RCT clinical trial for adults with type 1 diabetes examined how patients feel about new insulin delivery and glucose monitoring technology.
With the development of newer devices for both glucose monitoring and insulin delivery, it is essential to evaluate whether or not patient morale and satisfaction will genuinely benefit from the use of newer technologies. The HypoCOMPaSS RCT is a clinical trial for adults with long-standing type 1 diabetes who had documented hypoglycemic awareness and/or a history of recurrent severe episodes of hypoglycemia. The trial compared patient satisfaction while using insulin pumps versus multiple daily injections, as well as real-time continuous glucose monitoring versus conventional self-monitoring of blood glucose.
HypoCOMPaSS is a longitudinal trial with results being evaluated at the 6-month mark and then re-evaluated at the 2-year mark. To evaluate patient satisfaction, randomized patients completed two separate questionnaires. The first was titled “The Insulin Treatment Satisfaction Questionnaire” and its subscales, which measured device delivery and hypoglycemia control. The second was titled “The Glucose Monitoring Experience Questionnaire,” which assessed convenience, effectiveness, intrusiveness, and total satisfaction. All of the randomized patients were given equivalent education on all the studied devices as well as clinical support, which included several weekly follow-up visits.
Reports from the HypoCOMPaSS trial at six months reported non-inferiority between all of the measured treatment arms in biomedical outcomes, (multiple daily injections vs. continuous infusion and self-monitoring blood glucose vs. continuous glucose monitoring) for randomized treatment. However, using the more detailed subscales in both the questionnaires (ITSQ and GME-Q), it was found that there was a significant improvement over the 6-months about aspects of patient’s satisfaction for both the continuous glucose monitoring and insulin delivery devices. These same measures were evaluated at the two-year mark, and the results confirmed. At the 2-year mark, biomedical outcomes continued to show non-inferiority. The patient’s detailed questionnaire responses suggested that patients were even more satisfied with the continuous insulin delivery over the multiple daily doses and that they preferred to use continuous glucose monitoring over self-blood glucose monitoring. The data collected at the patient’s 2-year mark also suggests that patients do not like to switch methods. When given their preference of which modality to use for delivery and monitoring at their 6-month mark, their questionnaire responses were very similar at both 6-month and 2-years. Patients who used continuous glucose monitoring for more than half of the time between follow-ups had a higher questionnaire score than those who used continuous glucose monitoring for less than half the time. This suggests that patients valued continuity in their chosen modality.
Systematic reviews and meta-analyses of trials conducted in the past revealed that there had not been many random control trials that have compared patient satisfaction using the newer biomedical technologies with the traditional modalities for both insulin delivery and blood glucose monitoring. The few that have measured any relationships between these modalities usually reported mixed findings because detailed analysis and examination of patient responses were not completed. HypoCOMPaSS is also one of the few studies of its kind that ensured that all patients received education on all of the studied devices as well as frequent clinical follow-up and support. One exception to this generalization is the REPOSE trial, which reported biomedical non-inferiority between continuous insulin delivery versus multiple daily doses but higher satisfaction with continuous delivery. HypoCOMPaSS was also unique in terms of the selected population. Before HypoCOMPaSS, any trials which measured similar outcomes usually excluded groups considered to be high-risk. This included those with severe hypoglycemic episodes and hypoglycemic unawareness, which was the target population in this study.
It is essential to accurately measure and report the experiences of persons with diabetes to ensure that patients receive care that is cutting edge, efficient, but also feasible for the targeted patient group. This helps clinicians continuously improve the quality of care they provide for patients with diabetes. Measured biomedical outcomes can tell us if a device or product is functional and can produce clinical results. To find out if patients can sustain these results, it is imperative to evaluate responses from the groups of patients who will have to incorporate them into their everyday lives and routines. Even though HypoCOMPaSS reported non-inferiority of self-monitoring blood glucose versus continuous glucose monitoring and multiple daily insulin doses versus continuous insulin delivery, a detailed evaluation of patient satisfaction questionnaires confirmed that patients were more satisfied with continuous insulin infusion over multiple daily injections with regards to insulin delivery methods. No matter how much data there is, clinicians should always consult their patients on their preferences to ensure everyone is on the same page.
- Many patients with diabetes are beginning to prefer newer technologies for insulin delivery and glucose monitoring.
- Measured patient satisfaction was the highest with continuous insulin administration over multiple daily injections.
- Clinicians should always factor in patient preferences when determining what devices and regimens should be instituted.
Speight J, Holmes-Truscott E, Little SA, et al. 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. Diabetes Technology & Therapeutics. 2019;21(11):619-626. doi:10.1089/dia.2019.0152.
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 randomized trial (RE- POSE). BMJ 2017;356:j1285
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, doi:10.1089/dia.2019.0189.
Jordan Boyd, PharmD. Candidate Florida Agricultural & Mechanical University School of Pharmacy