1. INTRODUCTION
The joint American Diabetes Association/European Association for the Study of Diabetes 2022 consensus recommends initiating insulin without delay when glycaemic measurements do not reach targets and insulin is the best choice for the individual. 1 However, insulin adherence and persistence are significant challenges in diabetes management. 2 , 3 , 4 Furthermore, hypoglycaemia may limit management and result in insulin therapy discontinuation in people with type 2 diabetes (PwT2D). 5 , 6 Second‐generation basal insulins (BIs) like insulin glargine 300 U/mL (Gla‐300) have a more stable and prolonged duration of action with a favourable safety profile and may be a beneficial therapeutic option compared to first‐generation BIs. 7
Diabetes Treatment Satisfaction Questionnaire (DTSQ) is a widely used, short and well‐validated patient‐reported experience measure. It assesses treatment satisfaction with the current treatment and its continuation, convenience and flexibility, and perceived frequency of hyper/hypoglycaemia. 8 , 9 Moreover, in the absence of a gold standard, a distribution‐based approach, for example, based on half a standard deviation (SD), can be utilised to provide an estimated threshold to determine a meaningful change and make informed clinical decisions. 10 , 11 , 12 , 13
The real‐world ATOS study (NCT03703869) demonstrated improved glycaemic control and low hypoglycaemia after Gla‐300 initiation in PwT2D whose diabetes was uncontrolled with oral anti‐hyperglycaemic drugs. 14 , 15 This ATOS post‐hoc analysis evaluates changes in treatment satisfaction as measured by DTSQ, likely contributing to a better understanding of what constitutes a meaningful change in DTSQ scores following Gla‐300 initiation.
2. METHODS
ATOS was a 12‐month, real‐world study conducted in different geographical regions. The primary objective was to evaluate the percentage of participants achieving their pre‐defined individualised glycated haemoglobin (HbA1c) targets at month 6 among insulin‐naïve PwT2D receiving Gla‐300. The study design and primary results have been published. 14 A secondary objective of ATOS was to evaluate overall treatment satisfaction using DTSQ (Table S1). Of the total ATOS population, two populations for DTSQ analysis were defined: the eligible population for post hoc analyses, which included all participants who had signed an informed consent, met the inclusion/exclusion criteria, and initiated Gla‐300 ±31 days of the start of the study (for hypoglycaemic outcomes, BI dose and body weight) and the evaluable population, which included eligible participants with an HbA1c assessment at month 6 (for DTSQ and analyses of HbA1c, fasting plasma‐glucose [FPG] and self‐monitored plasma‐glucose [SMPG]).
Presently, no established criterion score (cut‐off) exists to determine a clinically meaningful change in DTSQ total score. Moreover, as a gold standard against which changes in the DTSQ score could be evaluated (anchor‐based approach) is lacking, we applied a distribution‐based approach, wherein half of SD of DTSQ status (DTSQs) scores at baseline was used to define meaningful change threshold. 13 The percentage of participants who achieved clinically meaningful change from baseline DTSQ scores at each post‐baseline visits, that is, change from baseline greater than or equal to the meaningful change threshold, were calculated along with their 95% confidence intervals (CIs). Participants for whom the treatment satisfaction total score improvement was above the meaningful change threshold at month 12 were classified as ‘DTSQs improvers’, whereas those with change in DTSQ total score below the meaningful change threshold were ‘DTSQs non‐improvers’.
DTSQs item‐level analysis, DTSQ change (DTSQc), change in DTSQs score, HbA1c, FPG and SMPG were also estimated. The model provided least square (LS) mean ± standard error (SE) estimates and 95% CIs for changes at months 3, 6 and 12. Spearman's correlation coefficients were computed for change in DTSQs scores versus change in HbA1c and FPG. Subgroup analysis was done for proportion of DTSQs improvers according to gender, age group, baseline body mass index (BMI) and diabetes duration. SAS® version 9.4 or higher was used.
3. RESULTS
The eligible population included 3801 participants of which, 3656 participants comprised the evaluable population (Figure S1). Baseline and demographic details are provided (Table 1).
TABLE 1.
Demographics and baseline characteristics by DTSQ response at month 12—eligible population (N = 3801).
| Baseline characteristics | DTSQs improvers at month 12 (N = 2860) | DTSQs non‐improvers at month 12 (N = 941) | All (N = 3801) |
|---|---|---|---|
| Age, mean (SD) (years) | 57.9 (10.4) | 56.9 (10.9) | 57.7 (10.5) |
| Age group, n (%) | |||
| Number | 2860 | 941 | 3801 |
| <65 | 2050 (71.7) | 705 (74.9) | 2755 (72.5) |
| 65–75 | 693 (24.2) | 191 (20.3) | 884 (23.3) |
| ≥75 | 117 (4.1) | 45 (4.8) | 162 (4.3) |
| Female | |||
| Number | 2860 | 941 | 3801 |
| n (%) | 1559 (54.5) | 468 (49.7) | 2027 (53.3) |
| Body weight (kg) | |||
| Number | 2408 | 804 | 3212 |
| Mean (SD) | 82.7 (16.2) | 78.5 (16.1) | 81.6 (16.3) |
| BMI (kg/m2) | |||
| Number | 2404 | 799 | 3203 |
| Mean (SD) | 29.9 (5.4) | 28.8 (5.2) | 29.6 (5.3) |
| BMI (kg/m2), n (%) | |||
| Number | 2404 | 799 | 3203 |
| <25 | 412 (17.1) | 185 (23.2) | 597 (18.6) |
| 25–30 | 934 (38.9) | 338 (42.3) | 1272 (39.7) |
| 30–35 | 676 (28.1) | 184 (23.0) | 860 (26.8) |
| ≥35 | 382 (15.9) | 92 (11.5) | 474 (14.8) |
| Duration of diabetes (years) | |||
| Number | 2860 | 941 | 3801 |
| Mean (SD) | 10.1 (6.1) | 10.2 (6.5) | 10.2 (6.2) |
| Duration of diabetes (years), n (%) | |||
| Number | 2860 | 941 | 3801 |
| 1–5 | 503 (17.6) | 185 (19.7) | 688 (18.1) |
| 5–10 | 1072 (37.5) | 326 (34.6) | 1398 (36.8) |
| ≥10 | 1285 (44.9) | 430 (45.7) | 1715 (45.1) |
| Region, n (%) | |||
| Number | 2860 | 941 | 3801 |
| South‐Eastern Asia | 16 (0.6) | 24 (2.6) | 40 (1.1) |
| Eastern Asia | 14 (0.5) | 35 (3.7) | 49 (1.3) |
| Southern Asia | 516 (18.0) | 362 (38.5) | 878 (23.1) |
| Western Asia | 570 (19.9) | 114 (12.1) | 684 (18.0) |
| Latin America and Caribbean | 163 (5.7) | 110 (11.7) | 273 (7.2) |
| Eastern Europe | 1408 (49.2) | 267 (28.4) | 1675 (44.1) |
| Northern Africa | 173 (6.0) | 29 (3.1) | 202 (5.3) |
| Basal insulin dose (U/kg) | |||
| Number | 2389 | 804 | 3193 |
| Mean (SD) | 0.18 (0.08) | 0.18 (0.08) | 0.18 (0.08) |
| Age of onset of diabetes (years) | |||
| Number | 2860 | 941 | 3801 |
| Mean (SD) | 50.0 (9.8) | 48.9 (10.3) | 49.7 (9.9) |
| Duration of OAD treatment (years) a | |||
| Number | 2860 | 940 | 3800 |
| Mean (SD) | 9.8 (6.0) | 9.8 (6.3) | 9.8 (6.1) |
| OAD use at baseline, n (%) b | |||
| Number | 2860 | 941 | 3801 |
| 1 OAD | 491 (17.2) | 180 (19.1) | 671 (17.7) |
| 2 OAD | 1432 (50.1) | 393 (41.8) | 1825 (48.0) |
| ≥3 OAD | 937 (32.8) | 368 (39.1) | 1305 (34.3) |
| OAD at baseline classification, n (%) | |||
| Number | 2860 | 941 | 3801 |
| Biguanides | 2546 (89.0) | 841 (89.4) | 3387 (89.1) |
| Sulfonylureas | 2150 (75.2) | 642 (68.2) | 2792 (73.5) |
| DPP‐4 inhibitors | 1130 (39.5) | 419 (44.5) | 1549 (40.8) |
| SGLT‐2 inhibitors | 324 (11.3) | 161 (17.1) | 485 (12.8) |
| Alpha‐glucosidase inhibitors | 134 (4.7) | 79 (8.4) | 213 (5.6) |
| Thiazolidinediones | 98 (3.4) | 44 (4.7) | 142 (3.7) |
| Glinides | 29 (1.0) | 13 (1.4) | 42 (1.1) |
| Any diabetes complication and comorbidity history, n (%) | |||
| Number | 2100 (73.4) | 724 (76.9) | 2824 (74.3) |
| Diabetic neuropathy | 1245 (43.5) | 325 (34.5) | 1570 (41.3) |
| Autonomic | 35 (1.2) | 6 (0.6) | 41 (1.1) |
| Peripheral | 1210 (42.3) | 319 (33.9) | 1529 (40.2) |
| Diabetic retinopathy | 578 (20.2) | 137 (14.6) | 715 (18.8) |
| Leading to blindness | 67 (2.3) | 15 (1.6) | 82 (2.2) |
| Renal function impairment c | 384 (13.4) | 129 (13.7) | 513 (13.5) |
| Related to | |||
| Diabetes | 358 (12.5) | 116 (12.3) | 474 (12.5) |
| Other conditions | 26 (0.9) | 13 (1.4) | 39 (1.0) |
| Types | |||
| Microalbuminuria | 259 (9.1) | 95 (10.1) | 354 (9.3) |
| Macroalbuminuria | 77 (2.7) | 18 (1.9) | 95 (2.5) |
| Advanced kidney disease | 46 (1.6) | 14 (1.5) | 60 (1.6) |
| End stage renal failure | 1 (<0.1) | 1 (0.1) | 2 (<0.1) |
| Hypertension | 1566 (54.8) | 520 (55.3) | 2086 (54.9) |
| Dyslipidaemia | 1413 (49.4) | 480 (51.0) | 1893 (49.8) |
| Coronary heart disease | 298 (10.4) | 89 (9.5) | 387 (10.2) |
| Acute myocardial infarction | 82 (2.9) | 31 (3.3) | 113 (3.0) |
| Heart failure | 150 (5.2) | 46 (4.9) | 196 (5.2) |
| Atrial fibrillation | 31 (1.1) | 8 (0.9) | 39 (1.0) |
| Stroke | 50 (1.7) | 19 (2.0) | 69 (1.8) |
| Transient ischemic attack | 29 (1.0) | 11 (1.2) | 40 (1.1) |
| Peripheral vascular disease | 177 (6.2) | 59 (6.3) | 236 (6.2) |
| Peripheral revascularisation | 12 (0.4) | 1 (0.1) | 13 (0.3) |
| Foot ulcer | 25 (0.9) | 6 (0.6) | 31 (0.8) |
| Lower limb amputation for arterial reason | 7 (0.2) | 3 (0.3) | 10 (0.3) |
| Fatty liver disease (steatosis or steatohepatitis) | 389 (13.6) | 97 (10.3) | 486 (12.8) |
| Chronic obstructive pulmonary disease | 38 (1.3) | 7 (0.7) | 45 (1.2) |
| Obstructive sleep apnoea | 35 (1.2) | 3 (0.3) | 38 (1.0) |
| Osteoarthritis | 201 (7.0) | 51 (5.4) | 252 (6.6) |
| Hip fracture | 6 (0.2) | 3 (0.3) | 9 (0.2) |
| Osteoporosis | 44 (1.5) | 20 (2.1) | 64 (1.7) |
| Ongoing malignant disease | 11 (0.4) | 5 (0.5) | 16 (0.4) |
| Depression | 55 (1.9) | 29 (3.1) | 84 (2.2) |
| Severe dementia | 2 (<0.1) | 1 (0.1) | 3 (<0.1) |
Note: Values are mean (SD) unless otherwise indicated.
Abbreviations: BMI, body mass index; CRF, case report form; DTSQs, Diabetes Treatment Satisfaction Questionnaire status version; DDP‐4, dipeptidyl peptidase‐4; FPG, fasting plasma‐glucose; HbA1c, glycated haemoglobin; OAD, oral anti‐hyperglycaemic drug; SD, standard deviation; SGLT‐2, sodium–glucose co‐transporter‐2; SMPG, self‐monitored blood glucose.
Duration calculated based on the participants who have reported at least one OAD in the concomitant CRF. Of the 3801 participants, 1 participant did not report the date of the first OAD intake.
OAD use at baseline was defined as the medications taken within 6 months of screening (i.e., taken in any time from the 6 months previous to informed consent [IC] date until the IC date).
Two participants who reported nephropathy were not counted here in relation to diabetes unknown.
3.1. DTSQs improvement
Overall results of the ATOS study for DTSQs scores are presented previously. 16 In this post hoc analysis, the SD of DTSQs at baseline of 7.4 led to a threshold for meaningful change of 4 points. In the evaluable population for post hoc analyses, the percentage of DTSQs improvers at month 12 was 76.0% (Figure 1). The cumulative distribution function curves of change in DTSQs are shown in Figure S2. Overall, 86.8% of participants who initiated Gla‐300 reported improved treatment satisfaction during the study (Table S2).
FIGURE 1.
Treatment satisfaction results according to improvement in DTSQs at month 12. The percentage of participants achieving clinically meaningful change—evaluable population (N = 3656). n, number of participants. DTSQs improvers are participants for whom the treatment satisfaction total score improvement is ≥4 points (i.e. 0.5 × SD of baseline DTSQs total score) from baseline. CI, confidence interval; DTSQs, Diabetes Treatment Satisfaction Questionnaire status version; SD, standard deviation.
Similar baseline characteristics were observed between DTSQs improvers and non‐improvers. However, at month 12, DTSQs improvers had a mean (SD) DTSQs total score slightly higher than DTSQs non‐improvers (Figure S3A). The mean (SD) scores for the perceived frequency of hyper/hypoglycaemia (item 2 and 3) are illustrated in Figure S3B.
No striking differences on item level were observed. Of the DTSQs improvers, 89% scored 5–6 points range for satisfaction with the current treatment at the end of month 12 (Figure S5). In DTSQs subgroup analysis, the percentage of DTSQs improvers was similar in subgroups when analysed based on gender, age group and diabetes duration, except for BMI (Tables S4–S7). At month 12, the mean (SD) DTSQc treatment satisfaction scores for DTSQs improvers was 15.03 (3.60) and DTSQs non‐improvers was 12.20 (5.35) (Figure S3C).
Correlation analysis showed a weak Spearman's coefficient correlation <0.4 between changes from baseline to month 12 in DTSQ and changes in HbA1c and FPG (Table S3). Proportion of participants reaching their individualised HbA1c target and change in the mean HbA1c, FPG and fasting SMPG, insulin dose and body weight in both groups at month 12 are illustrated in Figure S4A–F.
During the treatment period, at least one hypoglycaemic event (any hypoglycaemia) was reported in 50 (1.7%) and 29 (3.1%) participants of DTSQs improver and non‐improver groups, respectively (Tables S8 and S9).
4. DISCUSSION
This post hoc analysis showed meaningful improvement (defined as a change of 4 points) in treatment satisfaction upon Gla‐300 initiation in majority of participants at months 3, 6 and 12. Continuous improvement was observed in the treatment satisfaction total score of DTSQs improvers, with reduction in the perceived frequency of hyper/hypoglycaemia from baseline to month 12. Baseline characteristics of both DTSQ groups showed similarities, though at baseline in DTSQs improvers group, higher percentage of participants had comorbidities and reported a substantially lower treatment satisfaction level.
DTSQs item‐level scores (except item‐2 and ‐3) increased for DTSQs improvers, suggesting improved satisfaction, convenience and flexibility, with willingness to recommend and continue the same Gla‐300 treatment. Although, DTSQs improvers showed greater improvement, the non‐improvers also exhibited consistent treatment satisfaction score during the study period. However, the treatment satisfaction scores for non‐improvers did not meet the SD criteria considered for DTSQs improvers. The DTSQc scale overcomes the underestimation of treatment effects possibly due to baseline ceiling/floor scores, because the participants are asked to compare the new treatment with their previous treatment at the end of the trial. DTSQc scores improved in both groups, with a larger numerical difference in the improver group, indicating improvement in treatment satisfaction levels and confirming the outcomes from DTSQs analysis.
Furthermore, weak correlation was observed between DTSQs score change from baseline versus at month 12 in change in HbA1c and FPG, confirming that treatment satisfaction should not be replaced by clinical parameters. However, a numerically greater decrease in HbA1c and FPG from baseline to month 12 for DTSQs improvers was observed, even though the non‐improver group was more satisfied at baseline. The proportion of participants reaching individualised HbA1c targets was higher among DTSQs improver group, suggesting that reaching individualised glycaemic targets contributes to treatment satisfaction. In both groups, increase in mean BI dose and minimal body weight change from baseline to month 12 did not indicate any negative effects of Gla‐300 initiation.
Both perceived frequency of hyper/hypoglycaemia (item‐2 and ‐3) were inversely associated with treatment satisfaction. Moreover, lower hypoglycaemia event rates per patient‐year were observed in DTSQs improvers versus DTSQs non‐improvers, suggesting that hypoglycaemic event rates may influence participants' treatment satisfaction initiating Gla‐300.
In absence of a gold standard, the distribution‐based approach is recommended to identify a meaningful change in patient‐reported outcomes. 13 However, we recognised that in practice, along with outcomes gathered from statistical analyses, clinicians' judgement plays a role while making individualised treatment decisions incorporating patient‐reported outcomes. This balanced approach can facilitate the healthcare providers and PwT2D to make well‐informed shared decisions in routine clinical care. Thus, it is recommended to explore (changes in) satisfaction scores on the item level next to total scores.
In the absence of an established external indicator or ‘anchor’, we applied a distribution‐based method to determine clinically meaningful change in treatment satisfaction. Future studies should explore the possibility of using an anchor‐based approach alongside the distribution‐based approach, for which inputs from people with lived experience would be crucial. Furthermore, it is important to acknowledge that the associated confounding variables (other medications, waiting time on visits, etc.) might influence participant's response to the questionnaire. Nevertheless, the analysis provides the basis for future research focusing on clinically meaningful changes and estimating the significance of patient‐reported outcomes in diabetes treatment.
5. CONCLUSION
A distribution‐based approach can be applied to determine meaningful change in DTSQ scores and identify improvers versus non‐improvers. Initiating Gla‐300 resulted in meaningful improvements over time in treatment satisfaction as measured by DTSQ in insulin‐naïve PwT2D.
AUTHOR CONTRIBUTIONS
FS, GG, NK, AT, JK, HV‐U, HB and SH were involved in the conception of the study design/analysis. MAM, NG, VCG and JM substantially contributed to data collection/acquisition for the work related to this document. All authors substantially contributed to the data analysis/interpretation of the results, critically reviewed and approved the final version for submission and are accountable for the accuracy and integrity of this research letter.
FUNDING INFORMATION
The study and the journal's publication fee were funded by Sanofi.
CONFLICT OF INTEREST STATEMENT
FS received research funding (to institute) from Novo Nordisk and Sanofi and was a consultant/speaker for Abbott, Almirall, Sanofi, Lilly and Roche. MAM, NG, VCG and JM are employees of Sanofi and may hold shares and/or stock options in the company. AT, HV‐U, NK and GG were members of the ATOS Steering Committee and received honoraria in relation to ATOS. AT is a member of the National Diabetes Council and Head of the Diabetes Committee of the Israeli Endocrine Society and has received honoraria from Sanofi; a grant from Medtronic; consulting fees from Sanofi, Novo Nordisk, MSD, Merck, AstraZeneca, Medtronic and Dreamed Diabetes; and personal fees for participation in advisory boards from Sanofi, Novo Nordisk, MSD, Merck, AstraZeneca and Bayer. JK has no conflicts of interest. HV‐U received honoraria from Sanofi and Abbott and personal fees for participation in advisory boards and funding for attending meetings/travel from Sanofi. SH received research funding from BI, Novo Nordisk, Novartis and Eli Lilly and is a consultant/speaker for Abbott, Bayer, Dexcom, Eli Lilly, Novo Nordisk and Sanofi. HB is a consultant/speaker for Novo Nordisk, Sanofi and Lilly.
PEER REVIEW
The peer review history for this article is available at https://www.webofscience.com/api/gateway/wos/peer‐review/10.1111/dom.16415.
ETHICS STATEMENT
This study was conducted in accordance with the guidelines for Good Epidemiology Practice and principles laid down in the 1964 Declaration of Helsinki by the 18th World Medical Assembly and its later amendments. The study is registered at the US National Library of Medicine (Clinicaltrials.gov Number: NCT03703869). The study protocol was reviewed and approved by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies in accordance with the local regulations in each participating country/study centre. All participants provided written informed consent.
Supporting information
Data S1. Supporting information.
ACKNOWLEDGEMENTS
The authors are grateful to all study participants and thank all the trial staff and investigators who participated in the data collection for the study. The authors acknowledge Lydie Melas‐Melt, an employee of IVIDATA Life Sciences, for contributing to the statistical analysis. The authors acknowledge the medical writing assistance provided by Eshita Sharma, M. Pharm, and Amol Gujar, PhD, from Sanofi.
Snoek F, Galstyan G, Khan N, et al. Clinically meaningful improvements in treatment satisfaction in insulin‐naïve people with type 2 diabetes post initiation of insulin glargine 300 U/mL: A post hoc analysis of real‐world ATOS study. Diabetes Obes Metab. 2025;27(7):4011‐4016. doi: 10.1111/dom.16415
Part of the data was published as an abstract at the 84th Scientific Sessions of the American Diabetes Association, Orlando, FL, June 21–24, 2024.
DATA AVAILABILITY STATEMENT
Qualified researchers may request access to patient‐level data and related documents, including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan and dataset specifications. Patient‐level data will be anonymised, and study documents will be redacted to protect the privacy of trial participants. Further details on the data sharing criteria of Sanofi, eligible studies, and the process for requesting access can be found at https://www.vivli.org/.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1. Supporting information.
Data Availability Statement
Qualified researchers may request access to patient‐level data and related documents, including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan and dataset specifications. Patient‐level data will be anonymised, and study documents will be redacted to protect the privacy of trial participants. Further details on the data sharing criteria of Sanofi, eligible studies, and the process for requesting access can be found at https://www.vivli.org/.