Use of Connected Pen as a Diagnostic Tool to Evaluate Missed Bolus Dosing Behavior in People with Type 1 and Type 2 Diabetes

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Abstract

Objective: This study used connected pen to determine missed bolus dose (MBD) frequency during masked and unmasked continuous glucose monitoring (CGM) periods and examined its link with time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), and key participant characteristics in people with diabetes.

Methods: This was a 12-week, single-arm, exploratory, two-period study for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). The primary objective was to estimate the average number of MBD during masked and real-time CGM use. The secondary objective was to estimate the average percent TIR and its relationship to MBD. An exploratory objective was to investigate the participant characteristics that were associated with MBD. Data were analyzed for differences in MBD by diabetes type and other participant characteristics, by CGM period, and by hypoglycemic fear scores.

Results: Participants ( n = 64; T1D, n = 38; T2D, n = 26) were 48 ± 11.9 years old and 44% were female. From the masked to the unmasked period, MBD, %TAR, %TBR, and glycated hemoglobin decreased significantly (0.74 MBD/day to 0.62 MBD/day, P = 0.008; 53.6%–48.1%, P = 0.004; 4.49%–2.93%, P < 0.001; mean 8.8%–8.4%, P < 0.001, respectively), while %TIR increased significantly (41.9%–49.0%, P < 0.001). MBD/day was negatively associated with TIR ( P = 0.016) and positively associated with TAR ( P = 0.015) for T1D and positively associated with TBR ( P = 0.024) for T2D in the masked period only. MBD was significantly associated with fear of hypoglycemia for T2D, but not T1D.

Conclusions: MBD is associated with reduced TIR when CGM is masked and tailored therapeutic approaches are needed for T1D and T2D populations.

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Fitting Linear Mixed-Effects Models Using lme4

Douglas M Bates, Martin Mächler, Ben Bolker … (2015)

Maximum likelihood or restricted maximum likelihood (REML) estimates of the parameters in linear mixed-effects models can be determined using the lmer function in the lme4 package for R. As for most model-fitting functions in R, the model is described in an lmer call by a formula, in this case including both fixed- and random-effects terms. The formula and data together determine a numerical representation of the model from which the profiled deviance or the profiled REML criterion can be evaluated as a function of some of the model parameters. The appropriate criterion is optimized, using one of the constrained optimization functions in R, to provide the parameter estimates. We describe the structure of the model, the steps in evaluating the profiled deviance or REML criterion, and the structure of classes or types that represents such a model. Sufficient detail is included to allow specialization of these structures by users who wish to write functions to fit specialized linear mixed models, such as models incorporating pedigrees or smoothing splines, that are not easily expressible in the formula language used by lmer. Journal of Statistical Software, 67 (1) ISSN:1548-7660

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Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study

M Peyrot, A. Barnett, L F Meneghini … (2012)

Aims To examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens. Methods Internet survey of 1250 physicians (600 specialists, 650 primary care physicians) who treat patients with diabetes and telephone survey of 1530 insulin-treated patients (180 with Type 1 diabetes, 1350 with Type 2 diabetes) in China, France, Japan, Germany, Spain, Turkey, the UK or the USA. Results One third (33.2%) of patients reported insulin omission/non-adherence at least 1 day in the last month, with an average of 3.3 days. Three quarters (72.5%) of physicians report that their typical patient does not take their insulin as prescribed, with a mean of 4.3 days per month of basal insulin omission/non-adherence and 5.7 days per month of prandial insulin omission/non-adherence. Patients and providers indicated the same five most common reasons for insulin omission/non-adherence: too busy; travelling; skipped meals; stress/emotional problems; public embarrassment. Physicians reported low patient success at initiating insulin in a timely fashion and adjusting insulin doses. Most physicians report that many insulin-treated patients do not have adequate glucose control (87.6%) and that they would treat more aggressively if not for concern about hypoglycaemia (75.5%). Although a majority of patients (and physicians) regard insulin treatment as restrictive, more patients see insulin treatment as having positive than negative impacts on their lives. Conclusions Glucose control is inadequate among insulin-treated patients, in part attributable to insulin omission/non-adherence and lack of dose adjustment. There is a need for insulin regimens that are less restrictive and burdensome with lower risk of hypoglycaemia.

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Correlates of Insulin Injection Omission

Mark Peyrot, Richard R. Rubin, Davida Kruger … (2010)

OBJECTIVE The purpose of this study was to assess factors associated with patient frequency of intentionally skipping insulin injections. RESEARCH DESIGN AND METHODS Data were obtained through an Internet survey of 502 U.S. adults self-identified as taking insulin by injection to treat type 1 or type 2 diabetes. Multiple regression analysis assessed independent associations of various demographic, disease, and injection-specific factors with insulin omission. RESULTS Intentional insulin omission was reported by more than half of respondents; regular omission was reported by 20%. Significant independent risk factors for insulin omission were younger age, lower income and higher education, type 2 diabetes, not following a healthy diet, taking more daily injections, interference of injections with daily activities, and injection pain and embarrassment. Risk factors differed between type 1 and type 2 diabetic patients, with diet nonadherence more prominent in type 1 diabetes and age, education, income, pain, and embarrassment more prominent in type 2 diabetes. CONCLUSIONS Whereas most patients did not report regular intentional omission of insulin injections, a substantial number did. Our findings suggest that it is important to identify patients who intentionally omit insulin and be aware of the potential risk factors identified here. For patients who report injection-related problems (interference with daily activities, injection pain, and embarrassment), providers should consider recommending strategies and tools for addressing these problems to increase adherence to prescribed insulin regimens. This could improve clinical outcomes.

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Author and article information

Journal

Journal ID (nlm-ta): Diabetes Technol Ther

Journal ID (iso-abbrev): Diabetes Technol Ther

Journal ID (publisher-id): dia

Title: Diabetes Technology & Therapeutics

Publisher: Mary Ann Liebert, Inc., publishers (140 Huguenot Street, 3rd Floor New Rochelle, NY 10801 USA )

ISSN (Print): 1520-9156

ISSN (Electronic): 1557-8593

Publication date (Print): January 2022

Publication date (Electronic): 05 January 2022

Publication date PMC-release: 05 January 2022

Volume: 24

Issue: 1

Pages: 61-66

Affiliations

[ ¹ ]Eli Lilly and Company, Indianapolis, Indiana, USA.

[ ² ]Dexcom, Inc., San Diego, California, USA.

[ ³ ]Behavioral Diabetes Institute, San Diego, California, USA.

Author notes

[ * ]

The authors were employed at Eli Lilly and Company during the time of study.

[*]Address correspondence to: William Polonsky, Behavioral Diabetes Institute, 5230 Carroll Canyon Road, Suite 208, San Diego, CA 92121, USA whp@ 123456behavioraldiabetes.org

ⁱORCID ID ( https://orcid.org/0000-0001-9771-6344).

ⁱⁱORCID ID ( https://orcid.org/0000-0001-9064-6144).

Author information

Howard Wolpert https://orcid.org/0000-0001-9771-6344

William Polonsky https://orcid.org/0000-0001-9064-6144

Article

Publisher ID: 10.1089/dia.2021.0239

DOI: 10.1089/dia.2021.0239

PMC ID: 8783630

PubMed ID: 34524010

SO-VID: bf97c5a3-a3eb-4908-ba24-264bd6ec60de

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This Open Access article is distributed under the terms of the Creative Commons Attribution Noncommercial License [CC-BY-NC] ( http://creativecommons.org/licenses/by-nc/4.0/) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

Use of Connected Pen as a Diagnostic Tool to Evaluate Missed Bolus Dosing Behavior in People with Type 1 and Type 2 Diabetes

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Most cited references 16

Fitting Linear Mixed-Effects Models Using lme4

Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study

Correlates of Insulin Injection Omission

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