Effect of insulin therapy on quality of life in Type 2 diabetes mellitus: The Fremantle Diabetes Study

doi:10.1016/S0168-8227(00)00245-X

Diabetes Research and Clinical Practice

Volume 52, Issue 1, April 2001, Pages 63-71

https://doi.org/10.1016/S0168-8227(00)00245-X Get rights and content

Abstract

Previous studies investigating the relationship between insulin therapy on quality of life (QOL) in Type 2 diabetes have produced conflicting results that may reflect differences in patient samples, study design and context. To assess the effect of insulin on QOL in a community-based, prospective and observational setting, we studied 1290 Type 2 patients recruited from a region of 120 097 people and undergoing detailed annual assessments of metabolic control and complications. The average age of the cohort was 64.1 years, the median duration of diabetes was 4.4 years and 48.9% were males. A modified Diabetes Quality of Life (DQOL) questionnaire and a health measurement questionnaire providing the Rosser index were administered annually. At baseline, the 149 insulin-treated patients had greater satisfaction, worry, impact and total DQOL scores (indicating a worse QOL) than the 1141 non-insulin-treated patients (P≤0.018). Except in the case of satisfaction, these differences persisted after adjustment for potentially confounding demographic, socioeconomic and diabetes-specific variables (P<0.001). The Rosser index showed a similar pattern, with insulin-treated patients having lower values both before (P=0.012) and after (P<0.001) adjustment. During follow-up, 38 patients commenced insulin but there were no significant differences in DQOL scores or the Rosser index either side of this therapeutic change. In 389 patients on stable therapy and followed for 4 years, DQOL remained significantly higher in insulin-treated patients (P≤0.005). These findings suggest that, although positive factors including increased support and improved hyperglycaemic symptoms may initially offset unfavourable aspects of insulin self-administration, their effect wanes and a lower QOL supervenes after 1–2 years.

Introduction

The institution of insulin therapy can be a significant event in the life of a patient with Type 2 diabetes. It usually occurs on a background of many years of habitual diabetes self-management practices that may have to be changed, can act as a reminder of the progressive nature of the condition, and requires drug self-administration by a method that is both relatively complex and invasive. In addition, potentially beneficial effects on hyperglycaemic symptoms and chronic complications are set against the risk of increased hypoglycaemia and weight gain [1].

There have been a number of studies of the impact of insulin therapy on well-being and quality of life (QOL) in Type 2 diabetes. In the large-scale UK Prospective Diabetes Study (UKPDS), randomisation to insulin therapy was not associated with a significant change in QOL in a subset of 374 patients followed for 6 years [2]. Nevertheless, all UKPDS patients were newly diagnosed, those who were unwilling to consider insulin treatment were excluded, and almost all those who received insulin were in the intensive group and received non-standard care. In a study of 237 patients on diet and/or oral therapy [3], 39 of 157 with complete 2-year follow-up data had been started on insulin. Although insulin therapy did not influence physical and psychological well-being or treatment satisfaction in these patients, all were part of a shared-care project that involved 3-monthly review as part of intensified management [3]. Other small-scale studies have shown apparently discordant results, with the effects of insulin on well-being and/or QOL ranging from beneficial [4], [5], [6] to deleterious [7], [8].

The Fremantle Diabetes Study (FDS) is an ongoing observational prospective study of diabetes care, control and complications in a multi-ethnic urban Australian setting. Patients attend for an annual comprehensive assessment, an accepted part of usual diabetes care in Australia, but their diabetes management is otherwise at the discretion of their usual health professionals. We have used cross-sectional and prospective data, including QOL questionnaire responses, gathered from FDS patients between 1993 and the present, in order to assess the impact of insulin treatment on QOL in a setting outside an intervention study and involving a community-based sample of patients.

Section snippets

Patients

The FDS sample is drawn from a postcode-defined region of 120 097 people that includes the port of Fremantle in Western Australia and surrounding suburbs. The FDS protocol was approved by the Human Rights Committee, Fremantle Hospital and all patients gave informed consent to participation. Identification of patients was through hospital inpatient and outpatient lists, general practitioners, specialist physicians, allied health services, advertisements in pharmacies and local media, and word of

Clinical assessment

At their first annual visit, all FDS subjects had a comprehensive history taken and physical examination performed, and provided fasting blood and urine samples for automated biochemical analyses. Ethnic background was assessed from self-selection of one of six categories [9]: (1) Northern European (principally Anglo-Celts); (2) Southern European (family origins in Italy, Spain, Portugal or Greece); (3) Asian; (4) African; (5) Aboriginal/Torres Strait Islander (ATSI); and (6) Other (including

Patient characteristics

The details of the 1290 patients at study entry classified by whether or not patients were insulin treated are shown in Table 1. The patients on insulin comprised 11.5% of all FDS Type 2 diabetic patients. They were significantly older and had been diabetic for a median of 10 years longer than those not treated with insulin (P<0.001 in each case). The glycaemic control of the insulin-treated patients was worse than those on other therapies and they were significantly more likely to have one of

Discussion

Our data argue for a biphasic model of changes in diabetes-specific QOL after the institution of insulin therapy in patients with Type 2 diabetes from the community. In the subset started on insulin during follow-up, there were no significant differences in DQOL scores at the two annual FDS assessments either side of this change in therapy. It is likely that positive factors accompanying the introduction of insulin such as increased education, clinical care and family support, as well as the

Acknowledgements

We are grateful to Dorothy Ridley, Helen Lund, Sylvie Price, Kim Jacobsen, Giovanna Stuccio, Denise Jackson, Christine Jones, Mary Balme and David Bruce for help with collecting and recording clinical information. We thank John Robson, Simon Langton, Paul Chubb and other members of the Biochemistry Department at Fremantle Hospital for performing routine laboratory tests, and the Diabetic Education, Podiatry and Dietetic Departments for assistance with recruitment of patients. Paul Kind is

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The relationship between intensification of blood glucose-lowering therapies, health status and quality of life in type 2 diabetes: The Fremantle Diabetes Study Phase II
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Nevertheless, treatment intensification can also lead to better quality of life (QoL) [6], mainly through a reduction in symptoms associated with hyperglycaemia [7]. We previously studied the effect of insulin initiation on health status and QoL in patients with type 2 diabetes from a representative community-based sample of participants in the Fremantle Diabetes Study Phase 1 (FDS1) followed for four years from recruitment between 1993 and 1996 [8]. Initiation of insulin did not affect health status assessed using the Rosser Index [9,10] or QoL measured by a modified Diabetes Quality of Life (DQOL) instrument developed for type 1 diabetes [11], but patients on chronic insulin therapy had lower health status and diabetes-associated QoL than those on other therapies.
To determine whether therapeutic intensification in type 2 diabetes influences health status and quality of life (QoL).
We studied 930 participants in the longitudinal observational Fremantle Diabetes Study Phase II (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline assessment and two biennial reviews (4 years of follow-up) between 2008 and 2015. The main outcome measures were the Short Form-12 version 2 physical and mental health composite scores (PCS, MCS) and the average weighted impact (AWI) score from the Audit of Diabetes Dependent QoL.
There were reductions in PCS at Year 4 compared with baseline and Year 2 in patients on stable diet-based management (n = 160), oral glucose-lowering medication (OGLM; n = 387), and insulin with/without OGLM (n = 168; P < 0.05), but no statistically significant temporal changes in MCS/AWI. Insulin-treated patients had the lowest PCS, MCS and AWI compared to the other two subgroups at each time-point (P ≤ 0.012). In participants initiating OGLM (n = 84) or insulin (n = 85), there were no differences in PCS, MCS or AWI at the biennial assessments either side of these therapeutic changes (P ≥ 0.08).
These real-life data show that treatment intensification, including insulin initiation, does not impact adversely on patient well-being in community-based type 2 diabetes. Since insulin use at entry was associated with longer diabetes duration, worse glycaemic control, and a greater risk of chronic complications, the burden of disease rather than treatment modality appears the primary determinant of health status and QoL.
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Quality of life (QoL) assessment provides valuable outcome to support clinical decision-making, particularly for patients with chronic diseases that are incurable. A brief, 15-item diabetes-specific tool [i.e. Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI)] is known to be developed in English and validated for use in clinical practice. This simplified tool, however, is not readily available for use in the Malaysian setting.
To translate the DQoL-BCI into a Malaysian version and to assess its construct validity (factorial validity, convergent validity and discriminant validity), reliability (internal consistency) and floor and ceiling effects among the Malaysian diabetic population.
A forward-backward translation, involving professional translators and experts with vast experience in translation of patient reported outcome measures, was conducted. A total of 202 patients with Type 2 diabetes mellitus (T2DM) who fulfilled the inclusion criteria were invited to complete the translated DQoL-BCI. Data were analysed using SPSS for exploratory factor analysis (EFA), convergent and discriminant validity, reliability and test-retest, and AMOS software for confirmatory factor analysis (CFA).
Findings from EFA indicated that the 4-factor structure of the Malaysian version of DQoL-BCI was optimal and explained 50.9% of the variance; CFA confirmed the 4-factor model fit. There was negative, moderate correlation between the scores of DQoL-BCI (Malaysian version) and EQ-5D-3L utility score (r = −0.329, p = 0.003). Patients with higher glycated haemoglobin levels (p = 0.008), diabetes macrovascular (p = 0.017) and microvascular (p = 0.013) complications reported poorer QoL. Cronbach's alpha coefficient and intraclass coefficient correlations (range) obtained were 0.703 and 0.86 (0.734–0.934), indicating good reliability and stability of the translated DQoL-BCI.
This study had validated the linguistic and psychometric properties of DQoL-BCI (Malaysian version), thus providing a valid and reliable brief tool for assessing the QoL of Malaysian T2DM patients.
Increased healthcare utilization costs following initiation of insulin treatment in type 2 diabetes: A long-term follow-up in clinical practice
2017, Primary Care Diabetes
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International T2DM guidelines however recommend several options as second line treatment, including also more innovative second line treatment options, such as dipeptidyl peptidase (DPP)-4 inhibitors, sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RA) [13,14]. In addition to the benefits on glucose levels, insulin also carries a number of unwanted side effects like weight gain, hypoglycemia, reactions from injections and increased treatment complexity [15–18]. Furthermore, recent studies report associations between insulin and increased risk of cancer, cardiovascular disease and all-cause mortality [18–20].
To compare long-term changes in healthcare utilization and costs for type 2 diabetes patients before and after insulin initiation, as well as healthcare costs after insulin versus non-insulin anti-diabetic (NIAD) initiation.
Patients newly initiated on insulin (n = 2823) were identified in primary health care records from 84 Swedish primary care centers, between 1999 to 2009. First, healthcare costs per patient were evaluated for primary care, hospitalizations and secondary outpatient care, before and up to seven years after insulin initiation. Second, patients prescribed insulin in second line were matched to patients prescribed NIAD in second line, and the healthcare costs of the matched groups were compared.
The total mean annual healthcare cost increased from €1656 per patient 2 years before insulin initiation to €3814 seven years after insulin initiation. The total cumulative mean healthcare cost per patient at year 5 after second-line treatment was €13,823 in the insulin group compared to €9989 in the NIAD group.
Initiation of insulin in type 2 diabetes patients was followed by increased healthcare costs. The increases in costs were larger than those seen in a matched patient population initiated on NIAD treatment in second-line.
Second line initiation of insulin compared with DPP-4 inhibitors after metformin monotherapy is associated with increased risk of all-cause mortality, cardiovascular events, and severe hypoglycemia
2017, Diabetes Research and Clinical Practice
The objective of this nationwide study was to compare the risk of all-cause mortality, fatal and nonfatal cardiovascular disease (CVD), and severe hypoglycemia in patients with type 2 diabetes (T2D) on metformin monotherapy treatment starting second-line treatment with either insulin or dipeptidyl peptidase-4 inhibitor (DPP-4i).
All patients with T2D in Sweden who initiated second-line treatment with insulin or DPP-4i after metformin monotherapy during 2007–2014 identified in the Swedish Prescribed Drug Register were followed for outcome in the Cause of Death and National Patient Registers. Insulin and DPP-4i patients were matched 1:1 using propensity-score matching. Comparisons between groups were performed using unadjusted Cox regression models. Additionally, multivariate adjusted survival models were used to test the results using the full population without matching.
Of 27,767 mono-metformin-treated patients, 55.7% started insulin and 44.3% a DPP-4i, and after matching both groups had 9278 patients each. Median follow-up (patients years) times were 3.84 (37,578) and 3.93 (37,983) for insulin and DPP-4i-groups, respectively. Insulin compared with DPP-4i was associated with higher risk of subsequent all-cause mortality, fatal and nonfatal CVD, and severe hypoglycemia; adjusted HR (95% CI): 1.69 (1.45–1.96); 1.39 (1.21–1.61); and 4.35 (2.26–8.35), respectively. When performing multivariate adjusted analyses on the full population similar results were found.
Initiation of insulin, compared with DPP-4i treatment, was associated with an increased risk of subsequent all-cause mortality, fatal and nonfatal CVD, and severe hypoglycemia. Results from randomized trials will be important to elucidate causal relationships.
Evaluation of the quality of life of patients with diabetes mellitus treated with conventional or analogue insulins
2016, Diabetes Research and Clinical Practice
The results of two scales that measure quality of life of patients with diabetes mellitus treated with conventional or analogue insulin were evaluated and compared.
Descriptive, observational, cross-sectional study, conducted in the cities of Pereira and Manizales, Colombia, in a care facility between 1 August 2013 and 30 March 2014. A total of 238 patients diagnosed with diabetes mellitus type 1 or type 2 who had been undergoing treatment with conventional or analogue insulin for at least 6 months. Comparison of the results of the Diabetes 39 (specific) and European Quality of Life-5 Dimensions (EQ-5D) (generic) tools it was performed. Comparisons between the results of the two instruments were performed. Tests for parametric and non-parametric distribution (Pearson’s correlation coefficient, Mann–Whitney U test, Student’s t-test and Wilcoxon test) were used.
The mean age was 57.7 ± 16.6 years. Conventional insulin was prescribed to 69.6% of patients, and analogue insulin was prescribed to 30.4% of patients. Diabetes-39 (D-39) showed 24.7% of subjects with a high quality of life. No statistically significant differences were found when comparing patients prescribed conventional or analogue insulin (p = 0.35; 95% confidence interval [CI]: 0.375–1.419). In the EQ-5D survey, 45.7% claimed to have a high quality of life, without statistically significant differences between groups (p = 0.56; 95% CI: 0.676–2.047).
No differences between patients receiving conventional insulin versus analogue insulin were detected in terms of quality of life. The group aged over 60 years requires special attention to improve their quality of life, and programs should focus on those individuals.
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¹: This study was funded by an Aza Research Programme Grant and the Fremantle Diabetes Study as a whole by the Raine Foundation, University of Western Australia.

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Effect of insulin therapy on quality of life in Type 2 diabetes mellitus: The Fremantle Diabetes Study1

Abstract

Introduction

Section snippets

Patients

Clinical assessment

Patient characteristics

Discussion

Acknowledgements

Diabetes Res. Clin. Pract.

Eur. J. Vasc. Endovasc. Surg.

Well-being and symptoms in relation to insulin therapy in Type 2 diabetes

Diabetes Care

Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients

Diabetes Care

Quality of life following a change in therapy for diabetes mellitus

Pharmacoeconomics

Initiation of insulin treatment after 70 years of age: patient status 2 years later

Diabetes Med.

Longitudinal study on glycaemic control and quality of life in patients with Type 2 diabetes mellitus referred for intensified control

Diabetes Med.

Effect of insulin therapy on quality of life in Type 2 diabetes mellitus: The Fremantle Diabetes Study¹