Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study

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Abstract

Introduction

MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting.

Materials and methods

Participants were at least 18 years old, with T2DM for more than 1 year, HbA _1c 7.0–10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA _1c changes at months 3, 6, 9, and 12, and safety.

Results

MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p < 0.0001). The main reasons for Gla-300 initiation were to decrease HbA _1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p < 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed ( p < 0.05). There were no statistically significant changes in HbA _1c. Safety outcomes, including hypoglycemia, were comparable to previously reported trials.

Conclusions

The MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.

Electronic supplementary material

The online version of this article (10.1007/s13300-020-00866-2) contains supplementary material, which is available to authorized users.

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Most cited references 13

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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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Psychometric Properties of the Hypoglycemia Fear Survey-II for Adults With Type 1 Diabetes

Linda Gonder-Frederick, Karen Schmidt, Karen Vajda … (2011)

OBJECTIVE To perform the first comprehensive psychometric evaluation of the Hypoglycemia Fear Survey-II (HFS-II), a measure of the behavioral and affective dimensions of fear of hypoglycemia, using modern test-theory methods, including item-response theory (IRT). RESEARCH DESIGN AND METHODS Surveys completed in four previous studies by 777 adults with type 1 diabetes were aggregated for analysis, with 289 subjects completing both subscales of the HFS-II and 488 subjects completing only the Worry subscale. The aggregated sample (53.3% female, 44.4% using insulin pumps) had a mean age of 41.9 years, diabetes duration of 23.8 years, HbA1c value of 7.7%, and 1.4 severe hypoglycemic episodes in the past year. Data analysis included exploratory factor analysis using polychoric correlations and IRT. Factors were analyzed for fit, trait-level locations, point-measure correlations, and separation values. RESULTS Internal and test-retest reliability was good, as well as convergent validity, as demonstrated by significant correlations with other measures of psychological distress. Scores were significantly higher in subjects who had experienced severe hypoglycemia in the past year. Factor analyses validated the two subscales of the HFS-II. Item analyses showed that 12 of 15 items on the Behavior subscale, and all of the items on the Worry subscale had good-fit statistics. CONCLUSIONS The HFS-II is a reliable and valid measure of the fear of hypoglycemia in adults with type 1 diabetes, and factor analyses and IRT support the two separate subscales of the survey.

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Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes

Yoshifumi Saisho (2018)

The efficacy of diabetes treatment should not be evaluated solely by HbA1c levels as they should also focus on patient-reported outcomes (PROs), such as patient satisfaction, wellbeing and quality of life. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) has been developed to assess patient satisfaction with diabetes treatment. DTSQ has been translated into more than 100 languages and is widely used in many countries, since it is relatively easy to answer and is used for both patients with and without medical therapy. Novel therapeutic options, such as insulin analogs, incretin-based therapy and sodium-glucose cotransporter 2 (SGLT2) inhibitors, have been shown to improve patient satisfaction using DTSQ for assessments. DTSQ is not only used for comparisons between different medications or treatment strategies, but also can be used to assess the quality of diabetes care in clinical settings. This is important as an improvement in treatment satisfaction may enhance patients’ self-efficacy and adherence to therapy, leading to the achievement of long-term stable glycemic control and reduced risk of diabetic complications. In this review, we summarize the current topics in DTSQ, introducing our own experience, and discuss the role of PROs in diabetes treatment.

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Author and article information

Contributors

Ides M. Colin: Ides.Michel.COLIN@jolimont.be

Journal

Journal ID (nlm-ta): Diabetes Ther

Journal ID (iso-abbrev): Diabetes Ther

Title: Diabetes Therapy

Publisher: Springer Healthcare (Cheshire )

ISSN (Print): 1869-6953

ISSN (Electronic): 1869-6961

Publication date (Electronic): 8 July 2020

Publication date PMC-release: 8 July 2020

Publication date (Print): August 2020

Volume: 11

Issue: 8

Pages: 1835-1847

Affiliations

[1 ]Endocrino-Diabetology Clinical Research Unit, CHR Mons-Hainaut/Groupe Jolimont, Avenue Baudouin de Constantinople 5, 7000 Mons, Belgium

[2 ]GRID grid.476725.5, Sanofi, Airport Plaza, ; Montreal Building, Leonardo Da Vincilaan 19, 1831 Diegem, Belgium

[3 ]Lambda-Plus, Rue Camille Hubert 15, 5032 Gembloux, Belgium

[4 ]GRID grid.411374.4, ISNI 0000 0000 8607 6858, Division of Diabetes, Nutrition and Metabolic Disorders and Clinical Pharmacology Unit, , CHU Liège, ; 4000 Liège, Belgium

[5 ]GRID grid.411414.5, ISNI 0000 0004 0626 3418, Department of Endocrinology, Diabetes and Metabolism, , Antwerp University Hospital, ; 2650 Egedem/Antwerp, Belgium

Article

Publisher ID: 866

DOI: 10.1007/s13300-020-00866-2

PMC ID: 7376812

PubMed ID: 32643130

SO-VID: 5601d9b4-8d26-4cc2-9703-8526695eb94c

License:

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 28 May 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100004339, Sanofi;

Custom metadata

ScienceOpen disciplines: Endocrinology & Diabetes

Keywords: basal-bolus insulin regimen,hypoglycemia,insulin glargine 300 u/ml,quality of life,type 2 diabetes

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ScienceOpen disciplines: Endocrinology & Diabetes

Keywords: basal-bolus insulin regimen, hypoglycemia, insulin glargine 300 u/ml, quality of life, type 2 diabetes

Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study

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Abstract

Introduction

Materials and methods

Results

Conclusions

Electronic supplementary material

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Most cited references 13

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

Psychometric Properties of the Hypoglycemia Fear Survey-II for Adults With Type 1 Diabetes

Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes

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