Development of a Measure to Assess Attitudes Towards Nasal versus Autoinjector Glucagon Delivery Devices for Treatment of Severe Hypoglycemia

Abstract

Background

For individuals managing diabetes, the administration of glucagon for severe hypoglycemia can be lifesaving, yet, until recently, there were no easy-to-use devices for these stressful emergencies. New products have emerged to meet this need, including nasal glucagon (NG) and auto-injector glucagon (AI). This study evaluated the psychometric properties of a new measure, the Glucagon Device Attitudes Questionnaire (GDAQ), in assessing attitudes toward NG and AI from the perspectives of persons with diabetes on insulin (PWDs), caregivers, and acquaintances.

Methods

Developed based on qualitative research, the GDAQ consists of 38 rating items for each device and 16 direct-elicitation of attitudes of device relative to each other. It was administered to participants via a cross-sectional online survey. Twenty-six rating items were included in principal component analysis and confirmatory factor analysis. Items comprising each factor were averaged to form scales. Additionally, 12 direct elicitation items were averaged to form an overall “Attitudes” scale. Reliability and validity analyses were conducted. Descriptive statistics were provided for the rating items not included in the factor analysis.

Results

A total of 405 PWDs, 313 caregivers, and 305 acquaintances participated. Three factors were identified: “Prepared and Protected” (7 items), “Hesitation” (12 items), and “Device Perceptions by Others” (7 items); factor loadings ranged from 0.13 to 0.92, 0.50 to 0.89, and 0.16 to 0.92, respectively. Cronbach’s alpha for the four scales ranged from 0.76 to 0.96. Correlations of the scales with their global item ranged from 0.30 to 0.90. The items outside of the factor analysis showed good distribution in responses and differentiation between the two devices.

Discussion

This study supports the validity and reliability of the GDAQ, which successfully conceptualizes attitudes towards devices for administering glucagon among different respondent groups. Use of the GDAQ can help guide the development and testing of new glucagon drug/device combinations.

Keywords:

• diabetes
• severe hypoglycemic events
• glucagon delivery device
• patient attitudes

Abbreviations

AI, autoinjector; AQ, acquaintance; CFA, confirmatory factor analysis; CFI, comparative fit index; CG, caregiver; FDA, Food and Drug Administration; GDAQ, Glucagon Device Attitudes Questionnaire; NG, nasal glucagon; PCA, principal component analysis; PWD, person with diabetes on insulin; RMSEA, root mean square error of approximation (RMSEA); SRMR, standardized root mean square residual.

Data Sharing Statement

The datasets used and/or analyzed during the current study are available from Eli Lilly for reasonable request subsequent to Eli Lilly approvals of appropriate documentations, such as, appropriate confidentiality and data retention agreements as well as detailed protocols, analytic plans and publication/disclosure plans for the proposed usage of the data.

Ethics Approval and Informed Consent

All participants completed an Informed Consent Form. Exemption status from review by an ethics committee was received from the Sterling IRB on March 1, 2019 (Study ID 6494). This research met the terms of the US Department of Health and Human Service’s Policy for Protection of Human Research Subjects at 45 C.F.R. §46.101 (b) category 2 which refers to research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation.

Consent for Publication

All participants completed an Informed Consent Form (ICF) electronically. In the ICF, participants were informed that the results of the study may be published. Exemption status from review by an ethics committee was received from the Sterling IRB on March 1, 2019. This research met the terms of the US Department of Health and Human Service’s Policy for Protection of Human Research Subjects at 45 C.F.R. §46.101 (b) category 2 which refers to research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation.

Acknowledgments

Errol J. Philip PhD for writing support.

Author Contributions

All authors are responsible for the work described in this paper. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

SKB, JLP, QW, BDM, and NKR are full-time employees of Eli Lilly and Company (Indianapolis, IN, USA). CJC is a full-time employee of Eli Lilly and Company (Erl Wood Manor, Windlesham, UK). JLP, BDM, and CJC own stock in Eli Lilly and Company. MJCM, OW, EYP, JB, and KB are employees of Cerner Enviza, who provided consulting services on this study. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by Eli Lilly and Company. Cerner Enviza received funding from Eli Lilly and Company to conduct this study and to write and submit the paper for publication.