Lifestyle modification is the cornerstone in the prevention or delay of the development of type 2 diabetes. However, active commitment to change among people with prediabetes is often hampered due to the insidious nature of prediabetes, where those afflicted are presented with minimal to no health warning signs. Digital health technologies such as the flash glucose monitoring system (FGMS) sensors may instill timely lifestyle changes through real-time feedback among people with prediabetes.
We conducted a single-arm, prospective study in two federally qualified health center sites to evaluate the feasibility and acceptability of wearing FGMS sensors among people with prediabetes (University of California, Irvine, Institutional Review Board HS Number 2021-6701). Eligible candidates were invited to wear FGMS sensors for 28 days (equivalent to two sensors) through provider referral. Feasibility was measured through subject recruitment, predetermined as 30 subjects over a 3-month recruitment period (1); subject adherence rates of ≥70% and ≥60% for the first and second sensors, respectively; and subject retention rate of ≥85% at the end of the 28-day sensor wear (2,3). Acceptability was measured through a semistructured, one-on-one interview, which consisted of an 11-item FGMS satisfaction scale and four open-ended questions on sensor-related preferences/recommendations (4,5).
Among 136 eligible subjects referred between February and July 2021, 46 (33.8%) were uncontactable, 24 (17.6%) were undecided, and 34 (25.0%) declined due to disinterest or lack of time, leaving 32 (23.5%) subjects (18 male, 14 female) to enter the study. Among the 32 participants, the majority were Hispanic (10; 31.3%) or Asian (10; 31.3%), followed by Black (6; 18.8%), White (5; 15.5%), and others (1; 3.1%). The mean age and duration of prediabetes were 52 years and 1.5 years, respectively. More than half (27; 84.4%) of the participants reported to have a high school or college education. In addition, the majority of participants described their general health and understanding of diabetes as good (29; 90.6%) or fair (31; 96.9%). When asked to rate the importance to reverse prediabetes from 0 (not important at all) to 10 (very important), the average score was 9.7.
Over the 3-month recruitment period, approximately one in every three contactable subjects agreed to wear FGMS sensors for 28 days. All subjects were adherent to wearing the first followed by the second sensor. Sixteen sensors fell off accidentally, requiring replacement. The overall average days of sensor wear was 25 days.
Findings for satisfaction toward wearing FGMS sensors were largely positive (Fig. 1). Of note, 22 (68.8%) participants agreed or strongly agreed that they would pay a copay if their insurance covered the FGMS sensors for people with prediabetes, but some felt neutral (6; 18.8%) or strongly disagreed (3; 9.4%) due to financial instability from retirement or unemployment.
With respect to the response to the first open-ended interview question (“What was the best thing about wearing a sensor?), two themes were established, namely, “positive behavior change” and “improved understanding from real-time feedback.” Some participants reported that they had started going to the gym as a result, and others stated that they had stopped snacking. For the second question (“What was the worst thing about wearing a sensor?”), only one theme on “mechanics of the sensor” was established. Numerous patients disliked the fact that the sensor fell off easily and that it was bulky. For the third question (“In your opinion, what is an appropriate duration for wearing a FGMS sensor for someone with prediabetes?”), 29 (90.6%) answered that the appropriate duration was at least 1 month and periodically throughout the care as a form of reinforcement or at a 3-month interval, so that they could have their HbA1c levels checked by their care team for any improvement. For the last question (“Is there anything you would like to comment about wearing a FGMS sensor in people with prediabetes?”), two themes, namely, “keep an open mind” and “evidence to change” were established. The majority commented that people with prediabetes should give it a try and that visual feedback from wearing the FGMS sensor would allow them to make timely lifestyle changes to prevent progression to diabetes.
To the best of our knowledge, this is the first study that explored the feasibility and acceptability of wearing FGMS sensors among people with prediabetes. While we confirmed that people with prediabetes were receptive to wearing FGMS sensors, our study endured a high uncontactable rate, which was likely due to recruiting participants from medically underserved communities and the impact of the COVID-19 pandemic. Future studies should incorporate larger randomized controlled studies to better evaluate the advantages and disadvantages of incorporating FGMS sensors into the care of people with prediabetes.
This article is part of a special article collection available at diabetesjournals.org/journals/collection/52/Diabetes-and-COVID-19.
Acknowledgments. The authors would like to thank Ms. Leanne Funanda, Senior Manager/Assistant Operations Director at UCI Health Family Health Center—Santa Ana and UCI Health Family Health Center—Anaheim, and Ms. Claudia Islas, Ambulatory Practice Manger at UCI Health Family Health Center—Anaheim, for their administrative assistance. The authors would also like to thank Dr. Margaret Schneider, Evaluation Director from University of California, Irvine, Institute for Clinical and Translational Science, and Amanda Woodworth from University of California, Irvine, Pilot Studies Research Acceleration and Facilitation Team for their research guidance and support.
Funding. The project described was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through grant UL1 TR0001414.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Duality of Interest. No potential conflicts of interest relevant to this article were reported.
Author Contributions. J.Y.L., J.A., and T.T. conceived of the study and the study design. J.Y.L., J.T.N., J.A., and J.M. researched the data. J.T.N., T.T., D.H., and J.M. facilitated data collection and data analysis or interpretation. J.Y.L. wrote the paper. J.T.N., J.A., T.T., D.H., and J.M. reviewed and edited the manuscript and responded to the revision. J.Y.L. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Prior Publication. Parts of this study were presented as a poster (57-LB) at 82nd Scientific Sessions of the American Diabetes Association, New Orleans, LA, 3–7 June 2022.