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Abstract
Objective Insulin glargine 300 (Gla-300) provides less hypoglycemia risk and more flexibility in injection time. The extent to which these effects translate into improved patient-reported outcomes (PROs) is unknown, and is the subject of this observational study.
Research design and methods Adults with type 2 diabetes treated with basal insulin for at least 6 months initiating Gla-300 were included. Data were collected at baseline (start Gla-300) and at 3-month and 6-month follow-up. Patients and physicians gave reasons for switching to Gla-300 at baseline and the extent to which Gla-300 fulfilled their expectations at 6 months. Mixed model analyses examined PRO changes over time, with emotional well-being (WHO-5 Well-Being Index) as the primary outcome. The secondary outcomes were hypoglycemia incidence, hemoglobin A1c (HbA1c), hypoglycemia worries (worry subscale of the Hypoglycemia Fear Survey), diabetes distress (short form of the Dutch version of the Problem Areas In Diabetes Scale), diabetes medication convenience (Diabetes Medication System Rating Questionnaire (DMSRQ)), sleep quality and duration (Pittsburgh Sleep Quality Index), and adherence (Summary of Diabetes Self-Care Activities).
Results 162 patients participated: 53.70% were men, the mean age was 65.54 years (9.05), baseline mean HbA1c was 7.87% (1.15) (62.48 mmol/mol (12.61)), and mean diabetes duration was 15.14 years (6.65). Mean WHO-5 Well-Being Index scores improved non-significantly from 61.94 (19.52) at baseline (T0) to 63.83 (19.67) at 6 months (T2). Mean DMSRQ scores improved significantly from 32.96 (9.02) (T0) to 36.70 (8.85) (T2) (p<0.001). Dose (less volume) was a switching reason in 69.60% of patients and 63% of physicians, and flexibility in 33.30% and 24.70%, respectively. Gla-300 fulfilled the expectations or even better than expected in 92.30% of patients and 88.90% of physicians.
Conclusion In a relatively well-controlled sample of adults with type 2 diabetes, switching to Gla-300 improves diabetes medication convenience.
- well-being
- patient-reported outcomes
- insulin treatment in type 2 diabetes
- treatment satisfaction
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Footnotes
Contributors THW performed the data analyses and wrote the manuscript. MdW and FJS designed the study and reviewed the manuscript. JWRT supported THW in analyzing the data and reviewed the manuscript. All authors read and approved the final manuscript.
Funding This study was financially supported by Sanofi Netherlands. THW is the guarantor of this work and, as such, has full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analyses.
Competing interests Sanofi contributed to the study design. Physicians’ initial interest to participate in the study was given via an information leaflet, after which a Sanofi employee of the Clinical Study Unit performed an initiation visit for eligibility. Physicians (or their organization) received a monetary reward from Sanofi for participation. Data were collected by physicians and sent to a clinical research organization, which was responsible for data entering. The contract research organization created the database and sent it to Amsterdam UMC. Data analyses were under the responsibility of THW, MdW, and FJS, and were performed without participation of Sanofi.
Patient consent Not required.
Ethics approval In view of its observational and non-invasive nature, this study was deemed not subject to the Dutch Medical Research Involving Human Subjects Act.
Provenance and peer review Not commissioned; externally peer reviewed.
Data statement The dataset analysed during the current study is available from the corresponding author on reasonable request.