Insulin Treatment Satisfaction Research Articles

Patient-reported outcome measures for medication treatment satisfaction: a systematic review of measure development and measurement properties

BackgroundMedication Treatment Satisfaction (M-TS) from the patients’ perspective is important for comprehensively evaluating the effect of medicines. The extent to which current patient-reported outcome measures (PROMs) for M-TS are valid, reliable, responsive, and interpretable remains unclear. To assess the measurement properties of existing PROMs for M-TS and to highlight research gaps.MethodsUsing PubMed, Embase (Ovid), Cochrane library (Ovid), IPA (Ovid), PsycINFO, Patient-Reported Outcome and Quality of Life Questionnaires biomedical databases, and four Chinese databases, we performed a systematic search for studies addressing the development and validation of PROMs for M-TS. Based on the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, pairs of reviewers independently assessed the measurement properties of the PROMs and rated the quality of evidence on the measurement properties of each PROM. (The Open Science Framework registration: https://doi.org/10.17605/OSF.IO/8S5ZM).ResultsThis review identified 69 PROMs for M-TS in 114 studies (four generic, 32 disease-specific, and 33 drug-specific) of which 60 were intended for adults. All provided limited or no information regarding interpretability. Most demonstrated appropriate construct validity including convergent validity (39/69) and discriminative or known-groups validity (40/69) (high to moderate quality of evidence). Only a few provided evidence of sufficient content validity (8/69), structural validity (13/69), and internal consistency (11/69). Of 38 PROMs reporting test–retest reliability, results in 24 provided evidence of satisfactory test–retest reliability (18 with high to moderate, 6 with low to very low quality of evidence). Few PROMs reported responsiveness (16/69). Two generic PROMs (Treatment Satisfaction Questionnaire for Medication initial Version 1.4, TSQM-1.4; Treatment Satisfaction with Medicines Questionnaire, SATMED-Q) and one drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) demonstrated both satisfactory validity and reliability.ConclusionsMost existing PROMs for M-TS require further exploration of measurement properties. Reporting guidelines are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.

Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes.

Objective: To evaluate the safety and explore the efficacy of use of ultra-rapid lispro (URLi, Lyumjev) insulin in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology in children, teenagers, and adults living with type 1 diabetes (T1D). Methods: At 14 U.S. diabetes centers, youth and adults with T1D completed a 16-day lead-in period using lispro in a t:slim X2 insulin pump with Control-IQ 1.5 technology, followed by a 13-week period in which URLi insulin was used in the pump. Results: The trial included 179 individuals with T1D (age 6-75 years). With URLi, 1.7% (3 participants) had a severe hypoglycemia event over 13 weeks attributed to override boluses or a missed meal. No diabetic ketoacidosis events occurred. Two participants stopped URLi use because of infusion-site discomfort, and one stopped after developing a rash. Mean time 70-180 mg/dL increased from 65% ± 15% with lispro to 67% ± 13% with URLi (P = 0.004). Mean insulin treatment satisfaction questionnaire score improved from 75 ± 13 at screening to 80 ± 11 after 13 weeks of URLi use (mean difference = 6; 95% confidence interval 4-8; P < 0.001), with the greatest improvement reported for confidence avoiding symptoms of high blood sugar. Mean treatment-related impact measure-diabetes score improved from 74 ± 12 to 80 ± 12 (P < 0.001), and mean TRIM-Diabetes Device (score improved from 82 ± 11 to 86 ± 12 (P < 0.001). Conclusions: URLi use in the Tandem t:slim X2 insulin pump with Control-IQ 1.5 technology was safe for adult and pediatric participants with T1D, with quality-of-life benefits of URLi use perceived by the study participants. Clinicaltrials.gov registration: NCT05403502.

Effect of needle-free injection on psychological insulin resistance and insulin dosage in patients with type 2 diabetes.

Psychological insulin resistance (PIR), which refers to the reluctance of diabetic patients to use insulin, is a frequently encountered clinical issue. Needle-free injection (NFI) offers advantages in terms of expediting insulin absorption and mitigating adverse reactions related to injection. To evaluate the effects of subcutaneous injection of insulin aspart 30 with NFI on PIR and insulin dosage in patients with type 2 diabetes mellitus (T2DM). Sixty-four patients with T2DM participated in this randomized, prospective, open, crossover study. Insulin aspart 30 was administered subcutaneously to each subject via QS-P NFI and Novo Pen 5 (NP) successively. The effects of NFI on PIR were analyzed. Differences in insulin dosage, glycemic variability, and injection safety were compared at similar levels of glycemic control. After the administration of NFI, the insulin treatment attitude scale score decreased (53.7 ± 7.3 vs. 58.9 ± 10.7, p<0.001), the insulin treatment adherence questionnaire score increased (46.3 ± 4.9 vs. 43.8 ± 7.1, p<0.001), and the insulin treatment satisfaction questionnaire score increased (66.6 ± 10.5 vs. 62.4 ± 16.5, p<0.001). At the same blood glucose level, NFI required a smaller dosage of insulin aspart 30 compared with that of NP (30.42 ± 8.70 vs. 33.66 ± 9.13 U/d, p<0.001). There were no differences in glycemic variability indices (standard deviation, mean amplitude of glycemic excursion or coefficient of variation) between the two injection methods. Compared with NP, NFI did not increase the incidence of hypoglycemia (17.2% vs. 14.1%, p=0.774), and it decreased the incidence of induration (4.7% vs. 23.4%, p=0.002) and leakage (6.3% vs. 20.3%, p=0.022) while decreasing the pain visual analog scale score (2.30 ± 1.58 vs. 3.11 ± 1.40, p<0.001). NFI can improve PIR in patients with T2DM and be used with a smaller dose of insulin aspart 30 while maintaining the same hypoglycemic effect. https://www.chictr.org.cn/, identifier ChiCTR2400083658.

Association between glycemic control and patient-reported outcomes in adults with type 1 diabetes in Japan: the SAGE study subanalysis.

Psychosocial aspects and the quality of life (QOL) of individuals with diabetes are important for achieving glycemic control and treatment goals. Here, we describe patient-reported outcomes (PROs) of Japanese adults with type 1 diabetes (T1D) and evaluate the association thereof with glycemic control. This subanalysis of a subgroup of 528 Japanese participants in the SAGE study of adults with T1D used data on glycosylated hemoglobin (HbA1c) and PRO scores [Hypoglycemia Fear Survey-II (HFS-II), Problem Areas In Diabetes (PAID), Insulin Treatment Satisfaction Questionnaire (ITSQ), and Audit of Diabetes-Dependent QOL (ADDQoL)] and summarized the score by the predefined age groups (26-44-years: n = 208, 45-64-years: n = 217, and ≥ 65-years: n = 103). The association between PROs, achieving HbA1c < 7.0%, and individualized targets was explored using multivariate logistic regression analysis. The HFS-II and PAID scores were lower, and the ITSQ score was higher in the ≥ 65-years group than in the younger groups with a linear trend of better scores with increasing age (P for trend < 0.05). ADDQoL scores were similar across the age groups, and present QOL (ADDQoL subscale) tended to improve with age (P for trend < 0.05). Achieving HbA1c < 7.0% and individualized targets were associated with satisfaction with insulin treatment regarding glycemic control. In Japanese adults with T1D, the impact on psychosocial aspects and QOL varied across age groups, with a trend of improving scores with age, potentially in relation to the less stringent glycemic control targets adopted in older individuals. Glycemic control was significantly associated with treatment satisfaction. The online version contains supplementary material available at 10.1007/s13340-023-00668-4.

The Satisfaction level with Insulin Treatment in Type 1 Diabetics - Yazd Diabetes Research Center 2019

Objective: Diabetes is a non-communicable disease. The patient satisfaction with treatment is a key point of patient’s compliance. Definitive treatment for patients with type 1 diabetes is lifelong insulin injections, but type 1 diabetic patients are commonly in poor glycemic state due to poor compliance. Therefore, it is necessary to check insulin treatment satisfaction in this population. Therefore, the main purpose of this study was to evaluate the satisfaction of insulin treatment in patients with type 1 diabetes in Yazd.&#x0D; Materials and Methods: In this cross-sectional study, 114 patients with type 1 diabetes participated. Persian version of Insulin Treatment Satisfaction Questionnaire (ITSQ) used. All analyzes were performed by SPSS 22.&#x0D; Results: The overall satisfaction mean score in this study was 49.72(± 8.88). Insulin treatment satisfaction score had a significant positive correlation with BMI (P: 0.00) and age (P: 0.04). Hypoglycemic control subscale showed a positive correlation with BMI (P: 0.01) and age (P: 0.01). Also, inconvenience of insulin therapy regimen sub-scale showed a significant positive correlation with age (P: 0.04). Overall satisfaction and sub-groups had no significant correlation with other variables.&#x0D; Conclusion: The overall satisfaction in type 1 diabetics was unacceptable. Understanding the pathogenesis of this problem could guide health care providers for better and effective management of type 1 diabetes. Also, a more comprehensive approach with consider all potentially relevant variables is necessary.

Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial – A detailed statistical analysis plan

BackgroundThe evidence on the effects of metformin and insulin in type 2 diabetes patients on quality of life, patient satisfaction, and cardiovascular outcomes is unclear. MethodsThe Copenhagen Insulin and Metformin Therapy (CIMT) trial is an investigator-initiated multicentre, randomised, placebo-controlled trial with a 2 × 3 factorial design conducted at eight hospitals in Denmark. Participants with type 2 diabetes were randomised to metformin (n = 206) versus placebo (n = 206); in combination with open-label biphasic insulin aspart one to three times daily (n = 137) versus insulin aspart three times daily in combination with insulin detemir once daily (n = 138) versus insulin detemir once daily (n = 137).We present a detailed description of the methodology and statistical analysis of the clinical CIMT outcomes including a detailed description of tests of the assumptions behind the statistical analyses. The outcomes are quality of life (Short Form Health Survey (SF-36)), Diabetes Medication Satisfaction Questionnaire, and Insulin Treatment Satisfaction Questionnaire (assessed at entry and 18 months after randomisation) and cardiovascular outcomes including time to a composite of either myocardial infarction, stroke, peripheral amputation, coronary revascularisation, peripheral revascularisation, or death. DiscussionsThis statistical analysis plan ensure the highest possible quality of the subsequent post-hoc analyses. Trial registrationThe protocol was approved by the Regional Committee on Biomedical Research Ethics (H-D-2007-112), the Danish Medicines Agency (EudraCT: 2007-006665-33 CIMT), and registered within ClinicalTrials.gov (NCT00657943, 8th of April 2008).

Efficacy of the mHealth application in patients with type 2 diabetes transitioning from inpatient to outpatient care: A randomized controlled clinical trial

IntroductionNo studies have assessed the efficacy of telemedicine using a platform for recording and adjusting insulin doses in patients with diabetes mellitus type 2 (DM2) transitioning from inpatient to outpatient care. This study aimed to assess, in a population of patients with DM2, discharged from a tertiary referral hospital, whether treatment based on the use of an mHealth application was associated with better glycemic control at the 3-month follow-up, than standard care. MethodsThis open, randomized, controlled clinical trial included adult DM2 patients who were transitioning from inpatient to outpatient care. The efficacy and safety of patient management with and without mHealth was compared at the 3-month follow-up. The primary outcome was the change in the Glycosylated hemoglobin (HbA1c) levels. The secondary outcomes were the rates of hypoglycemic and hyperglycemic events and treatment satisfaction measured using the Insulin Treatment Satisfaction Questionnaire (ITSQ). ResultsIn total, 86 patients (41 using mHealth) were included in the clinical trial. HbA1c levels showed a significant decrease in both groups. The mean HbA1c level was significantly lower in the mHealth group. Patients using mHealth showed decreased incidence rate ratios of hypoglycemia 3.0 mmol/L [<54 mg/dl], hypoglycemia ranging from 3.0 to 3.8 mmol/L [54 to 70 mg/dl] and severe hypoglycemia. The level of satisfaction assessed using the ITSQ was higher in the mHealth group. ConclusionUsing mHealth in patients with DM2 transitioning from inpatient to outpatient care improves metabolic control and may reduce the hypoglycemia rates.

Determinants of insulin treatment satisfaction among type 2 diabetic older adults

IntroductionGlycemic control for elderly diabetics is a challenge. Treatment satisfaction reflects this control.ObjectivesTo determine the factors associated with insulin treatment satisfaction among type 2 diabetic elderly.MethodsA cross-sectional study on 86 type 2 diabetic insulin dependent elderly recruited from the outpatient endocrinology consultation during June and July 2021. We applied the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and geriatric assessment scores.ResultsThree quarters of the patients were satisfied with the insulin therapy. Satisfied patients had significantly less history of hospitalization and more regular follow-up. Diabetic neuropathy medications were significantly less taken by satisfied patients. The number of daily insulin injections was significantly higher in the unsatisfied patients. Diabetic foot was significantly more frequent in unsatisfied patients. Satisfied patients were significantly less depressed, more independent in both basic and instrumental activities of daily living, without memory impairment, in better nutritional status and not falling. Higher DTSQ scores were associated with regular follow up (β 7.92, 95% CI 1.83 to 34.3). Lower DTSQ scores were associated with the history of hospitalization (β 0.12, 95% CI 0.02 to 0.58), the taking of medications for diabetic neuropathy (β 0.07, 95% CI 0.09 to 0.51), the high number of insulin injections (β 0.43, 95% CI 0.19 to 0.97) and the presence of diabetic foot (β 0.17, 95% CI 0.01 to 0.38).ConclusionsRisk factors for patients’ insulin dissatisfaction should be detected early and managed appropriately to improve patients’satisfaction and consequently their well-being.DisclosureNo significant relationships.

814-P: Treatment Satisfaction in People with T2D Switched from Basal Insulin (BI) to Insulin Glargine 300 U/mL (Gla-300) : Patient-Reported Outcomes from ARTEMIS-DM Study

Treatment satisfaction is the key for treatment adherence, to improve long-term outcomes and avoid diabetes complications. However, there is limited data on treatment satisfaction in people with T2D who switch to Gla-300 from other BI in regions outside US and Europe. The current analysis of the 26-week ARTEMIS-DM study presents patient perspective on treatment satisfaction using the Insulin Treatment Satisfaction Questionnaire (ITSQ) , in people with T2D, from Asia, Middle East Africa (MEA) and Latin America (LaTAm) , uncontrolled on BI and who switched to Gla-300. A total of 362/372 (97.3%) participants completed the study. Mean ± SD ITSQ total score increased from baseline 76.30 ± 15.63 to 83.51 ± 13.29 and 84.42 ± 13.15 at Weeks 12 and 26, respectively. Improvements were noted for all ITSQ domain scores, especially glycemic control (baseline: 65.83; mean change from baseline to Week 12: 15.12 and Week 26: 16.06) (Table) . Despite similar mean baseline scores (73.to 79.31) , LS mean change in ITSQ total score was numerically greater in LaTAm (10.86) and MEA (10.40) compared with Asia (1.56) at Week 26. In ARTEMIS-DM study, in people with T2D uncontrolled on BI, switching to Gla-300 demonstrated improvement in treatment satisfaction and specifically in glycemic control in a diverse population from multiple geographic regions. Disclosure K.Alrubeaan: Research Support; Sanofi. E.G.Wilmot: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Sanofi, Research Support; Insulet Corporation, Novo Nordisk, Speaker's Bureau; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi. A.Roborel de climens: Employee; IQVIA Inc., Sanofi. M.N.Mabunay: Employee; Sanofi. V.Pilorget: None. B.Berthou: None. G.Frechtel: None. B.Sethi: None. Funding Sanofi

Patient-reported outcomes in adults with type 1 diabetes in global real-world clinical practice: The SAGE study.

To conduct a secondary analysis of the SAGE study to evaluate the association between glycaemic control and patient-reported outcomes (PROs), in adults with type 1 diabetes (T1DM) across different age groups and regions. SAGE was a multinational, cross-sectional, observational study in adults with T1DM. Data were collected at a single visit, analysed according to predefined age groups (26-44, 45-64, and ≥65 years), and reported across different regions. PRO questionnaires were applied to assess hypoglycaemia fear (Hypoglycemia Fear Survey-II), diabetes-related distress (Problem Areas In Diabetes questionnaire), insulin treatment satisfaction (Insulin Treatment Satisfaction Questionnaire), and diabetes-specific quality of life (QoL; Audit of Diabetes-Dependent Quality of Life). Multivariable analysis was performed to evaluate the relationship between glycated haemoglobin (HbA1c) target achievement (<7% and individualised targets) with PRO scores. The PRO scores showed relatively low levels of diabetes-related emotional distress and fear of hypoglycaemia, moderate to high treatment satisfaction, and low diabetes-related impact on QoL. Results were generally comparable across age groups with some regional variability. Achievement of the HbA1c <7% target was associated with less worry about hypoglycaemia, lower diabetes-related emotional distress, higher insulin treatment satisfaction, and higher QoL. Achievement of individualised HbA1c targets was associated with lower diabetes-related emotional distress and higher insulin treatment satisfaction. Better glycaemic control was most closely associated with low emotional distress due to diabetes and high patient-reported insulin treatment satisfaction.

44-LB: Insulin Treatment Satisfaction Questionnaire Results for PRONTO-Pump-2 Study

Background: In PRONTO-Pump-2, a Phase 3, 16-week, randomized, double-blind clinical trial in patients with type 1 diabetes on continuous subcutaneous insulin infusion (CSII), ultra rapid lispro (URLi; a novel mealtime insulin), showed superior postprandial glucose control and noninferior HbA1c reduction, with less hypoglycemia compared to Humalog® (Lispro). We assessed treatment satisfaction in patients enrolled in this trial (URLi, N=215; Humalog, N=217), using the Insulin Treatment Satisfaction Questionnaire (ITSQ). Methods: The ITSQ was administered to patients at baseline and endpoint (week 16 or early discontinuation). The 5 domains assessed were glycemic control, hypoglycemic control, insulin delivery device, inconvenience of regimen, and lifestyle flexibility. Domain scores were transformed to a scale of 0-100 for analysis, with higher scores indicating better treatment satisfaction. The change in each domain-specific and overall transformed score from baseline to endpoint (last observation carried forward) was analyzed using an ANCOVA model. Results: At endpoint, for patients treated with URLi, glycemic control scores had increased from a baseline of 66.9 by +7.0 (standard error [SE] 1.59; p&amp;lt;0.001), and scores for all other domains, except hypoglycemic control, had numerically increased. For patients treated with Humalog, glycemic control scores increased from a baseline of 61.3 by +3.9 (SE 1.51; p=0.010) while inconvenience of regimen scores decreased from a baseline of 80.0 by -2.5 (SE 1.13; p=0.029). At endpoint, the inconvenience of regimen score was significantly higher with URLi treatment compared to Humalog (between-treatment difference: 2.9 [95% CI 0.2, 5.6]; p= 0.034). No significant differences were observed in the overall ITSQ score between treatments. Conclusion: Patients with type 1 diabetes treated with URLi using CSII reported to be satisfied with the glycemic control they experienced and perceived URLi treatment to be more convenient than Humalog. Disclosure C. Piras de oliveira: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. R. Paczkowski: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Amgen Inc., Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Amgen Inc. J. Cho: None. R. Juneja: Employee; Self; Eli Lilly and Company. J. Poon: Employee; Self; Eli Lilly and Company. E. R. Hankosky: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. D. A. Ignaut: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company

Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Patients with T2D Uncontrolled on NPH or Premixed Insulins as Part of Routine Clinical Practice in Bulgaria: ToUPGRADE Study

IntroductionThe aim of this study is to demonstrate the real-life effectiveness and safety of insulin glargine 300 U/mL (Gla-300) in patients with type 2 diabetes (T2D) previously uncontrolled on NPH ± prandial insulin or premixed insulins in routine clinical practice in Bulgaria.MethodsThis was a 24-week prospective, observational study performed in 40 inpatient and outpatient sites across the country.ResultsA total of 286 patients were included in the study. The mean age (± SD) was 61.2 ± 10.0 years with duration of diabetes of 11.64 ± 7.5 years and body mass index (BMI) of 32.1 ± 5.7 kg/m2. HbA1c before Gla-300 initiation was 9.8 ± 1.0%, and fasting plasma glucose (FPG) was 13.1 ± 3.4 mmol/L. HbA1c and FPG change from baseline to week 24 was − 1.86% (p < 0.001) and − 4.8 mmol/L (p < 0.001), respectively. The proportion of patients reaching their individualized HbA1c at week 24 was 39.1% (95% CI 33.3–45.1%), while the proportion of patients reaching their individualized HbA1c target without confirmed and/or severe hypoglycaemia was 34.8% (95% CI 29.2–40.7%). At study end, 19.0% (95% CI 14.6–24.1%) achieved HbA1c < 7%. Body weight decreased from 88.3 to 87.0 kg from baseline to week 24 with mean change of − 1.3 kg (p < 0.001). The incidence and event rates of anytime confirmed (≤ 3.9 mmol/L) and/or severe hypoglycaemia were low: 7.7% and 0.42 events per patient-year, respectively. The overall Insulin Treatment Satisfaction Questionnaire (ITSQ) score increased from 53.2 to 78.2 from baseline to week 24 and the difference of 25.1 ± 21.5 points was significant (p < 0.001).ConclusionsIn real-life settings, Gla-300 significantly improved glycaemic control and insulin treatment satisfaction in people with T2D who were inadequately controlled with NPH ± prandial insulin or premixed insulin analogues. Improvement of glycaemic control was associated with a very low risk of hypoglycaemia and with significant weight loss irrespective of the previous insulin regimen. Video Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01022-0.

Treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine is comparable in patients with type 2 diabetes mellitus after switching from insulin glargine or insulin degludec: a post-marketing safety study

Objective To evaluate insulin treatment satisfaction, safety, and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice for Japanese patients with type 2 diabetes mellitus (T2DM) who switched from originator insulin glargine (100 U/mL) or insulin degludec treatment to GLY treatment. Methods The Insulin Treatment Satisfaction Questionnaire (ITSQ) was used to assess treatment satisfaction in a subgroup analysis of a post-marketing safety study. Hypoglycemia incidence rates and blood glucose control are also reported during the 12-month observation period for GLY-switched patients. Results Of 1104 patients with T2DM enrolled to participate, 565 patients switched from either insulin glargine U100/mL (n = 470) or insulin degludec (n = 95) to GLY. The mean total change from baseline to 3 months for total ITSQ score was 1.35 (95% confidence interval [CI] − 0.13 to 2.83, p = .073) for patients who switched from insulin glargine and 2.63 (95% CI −1.43 to 6.70, p = .195) for patients who switched from insulin degludec to GLY treatment. The mean change from baseline to 12 months in hypoglycemia events reported per month was −0.04% (95% CI −0.12 to 0.03, p = .236) for patients who switched from insulin glargine and no change for patients who switched from insulin degludec (0.00, 95% CI −0.20 to 0.20, p = 1.000). Non-significant mean changes from baseline to 12 months were observed for hemoglobin A1c and fasting plasma glucose in GLY-switched patients. Conclusions Treatment satisfaction does not change significantly in Japanese patients with T2DM who switch to GLY from the reference product or from insulin degludec. Safety and effectiveness over a 12-month period were similar in GLY-treated patients who switched from either insulin glargine or insulin degludec. ClinicalTrials.gov Not applicable.

1629-P: Association of Patient-Reported Outcomes (PROs) Scores with Glycemic Target Achievement in Type 1 Diabetes (T1D) in the SAGE Study

T1D is a chronic disease affecting both physical and psychosocial health. SAGE was a multinational, cross-sectional observational study using data from medical records and interviews of people (N=3858) aged ≥26 years with T1D for ≥1 year. The association between the achievement of general (HbA1c &amp;lt;7 %) or individualized HbA1c targets and PRO scores was analyzed by multivariate logistic regression, adjusted for region and age group. The following PROs are reported: Hypoglycemia Fear Survey (HFS-II) worry subscore, Problem Areas in Diabetes (PAID), Insulin Treatment Satisfaction Questionnaire (ITSQ), Audit of Diabetes-Dependent Quality of Life (ADDQoL). Overall, 24.3% of people achieved the general HbA1c target; 20.9% achieved individualized targets (most common target, HbA1c 7 % to &amp;lt;7.5 %). Lower emotional distress (PAID score) and higher treatment satisfaction (all ITSQ scores except Lifestyle domain) were associated with achievement of general and individualized HbA1c targets (Table). Lower HFS-II worry score and higher ADDQoL total scores were associated with achievement of HbA1c general target, but neither was associated with achieving individualized HbA1c targets. In people with T1D, lower diabetes-related emotional distress and higher treatment satisfaction appear to be associated with achievement of both general and individualized HbA1c targets. Disclosure E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. F. Ampudia Blasco: None. L. Berard: Consultant; Self; Abbott, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Becton, Dickinson and Company, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Montméd, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd. S. Brette: Other Relationship; Self; Sanofi. L.P. Calliari: Board Member; Self; Abbott, Medtronic, Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Lilly Diabetes. E. Fitts: Other Relationship; Self; N/A. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck &amp; Co., Inc. J.J. Gagliardino: None. F. Lauand: Employee; Self; Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. A. Roborel de Climens: Employee; Self; Sanofi. J. Seufert: Research Support; Self; Sanofi. Speaker’s Bureau; Self; Sanofi.

1626-P: Differences in Patient-Reported Outcomes (PROs) by Age and Region in Adults with Type 1 Diabetes (T1D) in the SAGE Study

T1D is a chronic disease impacting patients’ lives and psychosocial health; we explored how this may vary by age and region. SAGE was a multinational, cross-sectional observational study using data from medical records and interviews of participants (N=3858) aged ≥26 years with T1D for ≥1 year. Results from PROs questionnaires (Hypoglycemia Fear Survey [HFS-II], Problem Areas in Diabetes [PAID], Insulin Treatment Satisfaction Questionnaire [ITSQ], Audit of Diabetes-Dependent Quality of Life [ADDQoL]) were analyzed by region (Asia [A], Eastern Europe [EE], Western Europe [WE], Latin America [LA], Middle East [ME]) and age group (26-&amp;lt;45; 45-&amp;lt;65; ≥65 years). HFS-II scores showed fear of hypoglycemia was lowest in A for all age groups (Table). HFS-II scores increased with age in EE and decreased with age in LA. PAID scores showed highest levels of emotional distress in ME for all age groups. ITSQ scores showed treatment satisfaction increased with age in WE, LA and ME, and was more stable in EE and A. ADDQoL total scores showed a small negative impact of T1D on quality of life, with the highest and lowest impact in EE and ME, respectively, across all ages. PROs scores indicated relatively low levels of diabetes-related impact and high treatment satisfaction. Age and regional differences may reflect variations in T1D control and management, as well as cultural and healthcare-system-related factors. Disclosure L. Berard: Consultant; Self; Abbott, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Becton, Dickinson and Company, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Montméd, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd. F. Ampudia Blasco: None. S. Brette: Other Relationship; Self; Sanofi. D. Bruttomesso: Consultant; Self; Abbott, Eli Lilly and Company, Movi, Novo Nordisk, Roche Diagnostics, Sanofi. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck &amp; Co., Inc. H. Ikegami: None. D. Jurišic-Eržen: None. F. Lauand: Employee; Self; Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. V. Pilorget: Employee; Self; Sanofi. R. Balamurugan: None. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. A. Roborel de Climens: Employee; Self; Sanofi. Funding Sanofi

Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial.

Insulclock® is an electronic device designed to improve treatment adherence and insulin injection tracking. This randomized, single-center, pilot study assessed the clinical impact of Insulclock on glycemic control and variability, treatment adherence, and satisfaction in patients with uncontrolled type 1 diabetes mellitus (T1DM). We also compared these outcomes between the Active and Masked groups (with or without receiving reminders and app alerts). Sixteen patients completed the study: 10 in the Active group and 6 in the Masked group. Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL [1.5 mmol/L]; P = 0.013), glucose standard deviation (-14.4 mg/dL [0.8 mmol/L]; P = 0.003), and time above range (-12.5%; P = 0.0026), and an increase in time in range (TIR) (+7%; P = 0.038) in the overall population. The use of app information and alerts in the Active group was associated with an increase in TIR (+8%; P = 0.026). We observed a -3.9 (P = 0.1352) and -5.4 (P = 0.032) reduction per month in the number of missed and mistimed insulin doses in the overall population, respectively. Most of the items of the Insulin Treatment Satisfaction Questionnaire (ITSQ) improved after 4 weeks of Insulclock use. This pilot study points out an improvement in glycemic levels, adherence, and satisfaction in T1DM patients, supporting the development of clinical trials powered to confirm these effects.

Improved insulin injection technique, treatment satisfaction and glycemic control: Results from a large cohort education study

ObjectiveThe aim of this study was to elucidate injection techniques, treatment satisfaction and glycemic control after education among patients with type 2 diabetes. Methods4513 insulin-treated diabetic patients enrolled in the observational study EGIDA II (Education and GensuPen In Diabetology II) filled out the questionnaire which focused on key insulin injection parameters, pain sensation scale and satisfaction of the treatment form before (visit 1) and after 3 months treatment with insulin injection (visit 2). The education was performed by trained healthcare professionals. To assess the utility and comfort during using new automatic injection system (GensuPen) we separated 2 groups: A – treated with GensuPen and B – treated with other pens. ResultsThe education resulted in increased number of patients who properly remix cloudy insulin; inject insulin into skin; change every time the injection site; use the pen needle only once; prepare a pen for injection and store insulin. We noticed significant decrease in BMI and sensation of pain in both groups. Our study revealed that patients’ satisfaction with the treatment increased with each of the 5 items (type of the treatment, mood, physical activity, vital energy, a sense of control over the disease) using a 5-point scale, with greater increase in group A. The utility and comfort (weight, thickness, easiness in remove pen cap, cleaning, twisting, keeping in hand the pen, dial the dose, readable signaling of injected dose) during using the GensuPen significantly increased in group A. Finally the mean glucose level in self-control diary was significantly lower after 3 months of the treatment in both groups, however the difference between visit 1 and 2 was greater in group A. ConclusionThe study showed that proper selection of pen and professional education can result in the improvement of insulin injection technique, higher patients’ satisfaction and better glycemic control.

Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study

BackgroundThe duodenum has become a metabolic treatment target through bariatric surgery learnings and the specific observation that bypassing, excluding or altering duodenal nutrient exposure elicits favourable metabolic changes. Duodenal mucosal...

Parental Satisfaction on Multiple Daily Injections, Insulin Pump and Flexible Multiple Daily Injections Used for Children with Type 1 Diabetes Mellitus

Aims: This study aims to identify differences in parental satisfaction between three distinct types of intensive insulin therapies used for children with type 1 diabetes (T1D) namely multiple daily injection (MDI), continuous subcutaneous insulin infusion (CSII) and flexible multiple daily injection (fMDI). Materials and Methods: Data was collected over a 6-month period during the quarterly clinic visits. Two modified versions of validated tools- Insulin Treatment Satisfaction Questionnaire (ITSQ) and Diabetes Treatment Satisfaction Questionnaire (DTSQ), were electronically filled in by the parents of children with T1D. This provided information on parental satisfaction on the following areas: inconvenience of regimen, lifestyle flexibility, impression of glycaemic control, fear of hypoglycaemia, diabetic symptoms, treatment barriers, worry, treatment adherence and communication. Results: 34 parents completed the electronic data forms on iSurvey. Parents of the fMDI group were the most confident to avoid severe hypoglycaemia whereas MDI-parents being the least confident, t (21) = 2.12, p = 0.046. There was no statistical difference noted on how confident parents felt to avoid asymptomatic hypoglycaemia, their worry about nocturnal hypoglycaemia, convenience and ease of using insulin in public places, nor was there statistically significant difference in the pain and discomfort felt by their children. Parents of children with fMDI felt the time their children spent with hyperglycemia was higher than the MDI, t (21) = 2.11, p = 0.047. Parents of the CSII group were most likely to continue their current treatment and were also, most likely to recommend the treatment regimen to others. Parents of MDI were least likely to do so, t (20) = 2.12, p =.047 and t (18) = 2.35, p = 0.031. Conclusion: Although this study was conducted with a very small sample size, it has revealed no significant difference in parental satisfaction among MDI, CSII and fMDI groups including parental anxiety and stress, ease of use in public places, convenience, flexibility, parental perception of pain and discomfort experienced by their children and fear of nocturnal hypoglycaemia. However, parents indicated greater confidence in avoiding severe hypoglycaemia in fMDI albeit there was higher glycaemic variability. Parents with CSII were more satisfied with treatment and more likely to recommend their current treatment option to others, than fMDI and MDI, as the preferred mode of treatment.

Adults with Type 1 Diabetes (T1D) Using Continuous Glucose Monitoring (CGM) Report Disease Has Little Impact on Daily Functioning—T1D Exchange

Glycemic Variability (GV) and Treatment Satisfaction (TS) are not accurately reflected in HbA1c. This study explored GV measures and their effect on insulin TS, productivity and activity in a real-world population with T1D. This prospective survey was of 98 adults from the T1D Exchange online patient community. Surveys were completed and CGM data were downloaded at baseline and weekly thereafter for 4 weeks (week). The Insulin Treatment Satisfaction Questionnaire was done at week 4, and Work Productivity Impairment (WPI) and Activity Impairment (AI)-General Health Questionnaire were done weekly for 4 weeks. Linear regression and mixed models explored the relationship between GV and TS, and impairment, respectively. Overall mean age was 43 years (SD 15.3), mean years with T1D was 22 (SD 14.2), 68% were female, and mean self-reported most recent HbA1c was 6.8% (SD 0.8). Participants on insulin pump (n=86) and multiple daily injections (n=12) took an average of 47.7 Units (±35.8) and 39.3 Units (±23.1) of insulin, respectively. Markers of GV and patient reported measures are in Table. Of the 14 GV measures examined, CV and LBGI showed a positive association with insulin TS (p&amp;lt;.05). No GV measures significantly impacted WPI or AI. The adult population with T1D in this survey had high TS, and had low WPI and AI, despite overall moderate risk for hypoglycemia. Disclosure L. Fan: Employee; Self; Eli Lilly and Company. C. Garey: None. J. Liu: None. B. Mitchell: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J. Bispham: None. A.H. McAuliffe-Fogarty: Advisory Panel; Self; Novo Nordisk Inc..