OBJECTIVE | Approximately 200 million people worldwide use injectable therapies as part of diabetes management. There appears to be a significant gap between insulin injection technique recommendations and injection practice for many. We aimed to develop and validate a novel, brief, self-administered injection technique assessment questionnaire.RESEARCH DESIGN AND METHODS | An iterative codesign process was conducted. Focus groups and interviews with adults (or parents of children) with type 1 or type 2 diabetes and health care providers (HCPs) elicited views and refined the tool for broader distribution to the target audience. Questions addressed ease of understanding; relevance; included items and potential missing questions; feelings about diabetes; and any discomfort or judgment felt when completing the tool. A user guide was developed with cognitive interviewing performed to ensure relevance, acceptability, readability, and understanding. Statistical analyses included propensity score matching to identify a subset of the Worldwide Injection Technique Questionnaire with similar characteristics. Boruta feature selection, Cramér's V, and multiple correspondence analysis were conducted.RESULTS | HCPs and 16 people with diabetes participated in the initial focus groups and interviews. Questions were reported as clinically relevant, simple to complete, "about the right length," relevant, and easy to understand. A total of 267 participants completed the survey reviewing the questionnaire. A further 16 participants underwent cognitive interviews. The complete resource was then reviewed by another 23 people with diabetes as a final check for completeness and usability. Statistical analyses demonstrated high validity and reliability.CONCLUSION | This novel resource is clinically relevant, acceptable, and easy to use as both a clinical tool and a selfassessment tool for people using injectable therapies for diabetes.
Approximately 200 million people worldwide use injectable therapies as part of diabetes management. There appears to be a significant gap between insulin injection technique recommendations and injection practice for many. We aimed to develop and validate a novel, brief, self-administered injection technique assessment questionnaire.
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BACKGROUND Studies of mobile diabetes applications (apps) have demonstrated improvements in glycemia, and patient reported outcomes (PROs). In addition, the potential for reduced glycemic variability has been realized through the use of shorter pen needles (PN) and adoption of proper injection techniques. OBJECTIVE To determine the impact of using a diabetes mobile app plus a novel 4 mm pen needle (PN) on patient reported outcomes (PROs) and glycemic outcomes in people with T2DM using multiple daily injections (MDI) of insulin. METHODS This was a prospective, parallel group, randomized controlled trial. People with T2DM administering MDI with baseline hemoglobin A1c (HbA1c) concentrations of 8% - 11% were enrolled. The study lasted 10 weeks with PRO’s answered Pre/Post. Subjects wore a blinded flash glucose monitor (fGM) the first two and last two weeks. Following fGM use, subjects were randomized 1:1 to either Intervention (BD Diabetes Care (DC) App + BD Nano 2nd Gen PN) or Control for 8 weeks. Controls used their current PN and did not use diabetes apps. At study end, the Intervention group answered a survey on satisfaction with the app and PN. RESULTS Fifty-eight subjects were randomized and 57 completed the study (Intervention n=27, Control n=30). Mean (SD) age of subjects was 53.8 ± 10.3 (mean ± SD) years and duration of insulin therapy was 9.5 ± 6.5 years. At study end, there were no significant differences in PROs between groups, except an improvement in medication adherence (ARMS-D) in Controls, leading to significant between-group differences (P = 0.04). From fGM data, there were no significant differences in most glycemic measures between groups except for a trend for improved glycemic variability as measured by the mean amplitude of glycemic excursions (MAGE) in the Intervention group (P = 0.06). Controls spent significantly less time in hypoglycemia but had a 2 to 3-fold higher incidence at baseline. Intervention subjects had numerical improvements in several glycemic parameters whereas Controls had numerical decrements in these values over the study. In general, Intervention subjects reported satisfaction with the app and PN. CONCLUSIONS This is the first BD DC App study, in combination with BD Nano 2nd Gen PN, to assess glycemic outcomes. The Intervention showed a trend for improved glycemic variability and numerical improvements in several glycemic measures over the course of the study. This combination intervention shows promising results for reduced glycemic variability and the potential to positively impact patients’ diabetes self-management. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT04090242
Approximately 200 million people worldwide use injectable therapies as part of diabetes management. There appears to be a significant gap between insulin injection technique recommendations and injection practice for many. We aimed to develop and validate a novel, brief, self-administered injection technique assessment questionnaire.
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