Multiple Daily Injection Regimen Research Articles

Diabetes and COVID-19: A Tale of 2 Pandemics.

Diabetes and COVID-19: A Tale of 2 Pandemics.

107-LB: Relative Contribution of Fasting Plasma and Postprandial Glucose to HbA1c and TIR in People with T1D on Basal-Bolus Insulin Therapy

Background: A recent report was published on the contribution of fasting plasma glucose (FPG) and postprandial glucose (PPG) to HbA1c and time in range (%TIR) in people with type 2 diabetes on multiple daily injection regimens using prandial Humalog® (Lispro). We extended this analysis to type 1 diabetes (T1D) using data from people randomized to 26 weeks of mealtime ultra rapid lispro (URLi; N=451), postmeal URLi (N=329) or mealtime Humalog (N=442) in the phase 3 trial, PRONTO-T1D, and its continuous glucose monitoring (CGM) substudy. Methods: A multivariate regression model was used to quantify the contribution of FPG and PPG change to the change in HbA1c and %TIR. The contribution of PPG relative to FPG was determined. %TIR was derived from 10-point self-monitored blood glucose (SMBG) and CGM data from the CGM substudy. Only results for the mealtime groups are presented here. Results: With URLi treatment, a 1 mmol/L reduction in FPG and PPG was associated with a 0.11% ± standard error 0.02% and 0.09% ± 0.01% reduction in HbA1c, respectively, both p<0.0001, with a contribution of PPG relative to FPG of 82%. Similar results were obtained with Humalog: A 1 mmol/L reduction in FPG and PPG was associated with reduction in HbA1c of 0.12% ± 0.02% and 0.07% ± 0.02%, respectively, both p<0.0001, but the contribution of PPG relative to FPG was 58%. For SMBG-derived %TIR, with URLi treatment, a 1 mmol/L reduction in FPG and PPG was associated with an increase in %TIR of 10.0% ± 0.53% and 8.6% ± 0.47%, respectively, all p<0.0001. Similarly, with Humalog, a 1 mmol/L reduction in FPG and PPG was associated with an increase in %TIR of 9.8% ± 0.56% and 8.6% ± 0.52%, respectively, all p<0.0001 A similar trend was observed with CGM data, although the absolute values of contributions of FPG and PPG differed. Conclusions: Changes in FPG and PPG significantly impacted HbA1c and %TIR in people with T1D, reinforcing the need to manage both FPG and PPG to achieve optimal glycemic control. Disclosure C. Piras de oliveira: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. M. A. Dellva: Employee; Self; Eli Lilly and Company. J. M. Bue-valleskey: Employee; Self; Eli Lilly and Company. A. M. Chang: Employee; Self; Eli Lilly and Company. F. B. Chigutsa: None. B. Liao: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company

Efficacy of a glucose meter connected to a mobile app on glycemic control and adherence to self-care tasks in patients with T1DM and LADA: a parallel-group, open-label, clinical treatment trial.

The main aim of the study was to evaluate the patients' glycemic control and adherence to self-care tasks. Patients with type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes of the adult (LADA) using a multiple daily injection (MDI) regimen with carbohydrate counting (n = 25, Subgroup B) or fixed insulin dose (n = 25, Subgroup C) were allocated to use the application (app) for 12 weeks. Both subgroups were compared with each other and against a control group (n = 25, Group A) comprising patients with T1DM or LADA treated with continuous subcutaneous insulin infusion (CSII) in a parallel-group, open-label, clinical treatment trial. All patients had glycated hemoglobin (A1C) levels measured and were asked to fill out the Diabetes Self-Management Profile (DSMP) questionnaire at study start and end. The patients were instructed to measure capillary glucose six times daily in study weeks 4, 8, and 12. Mean A1C levels decreased 0.725% in Subgroup C in intragroup analysis (p = 0.0063), and had a mean variation of 0.834% compared with Group A (p = 0.003). Mean DSMP scores increased 5.77 points in Subgroup B in intragroup analysis (p = 0.0004) and increased by a mean of 6.815 points in relation to Group A (p = 0.002). OneTouch Reveal improved both A1C levels and DSMP scores in patients with T1DM or LADA compared with standard treatment (CSII).

Type 1 Diabetes Management With Technology: Patterns of Utilization and Effects on Glucose Control Using Real-World Evidence.

This retrospective cohort study evaluated diabetes device utilization and the effectiveness of these devices for newly diagnosed type 1 diabetes. Investigators examined the use of continuous glucose monitoring (CGM) systems, self-monitoring of blood glucose (SMBG), continuous subcutaneous insulin infusion (CSII), and multiple daily injection (MDI) insulin regimens and their effects on A1C. The researchers identified 6,250 patients with type 1 diabetes, of whom 32% used CGM and 37.1% used CSII. A higher adoption rate of either CGM or CSII in newly diagnosed type 1 diabetes was noted among White patients and those with private health insurance. CGM users had lower A1C levels than nonusers (P = 0.039), whereas no difference was noted between CSII users and nonusers (P = 0.057). Furthermore, CGM use combined with CSII yielded lower A1C than MDI regimens plus SMBG (P <0.001).

Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy.

BACKGROUNDGlycemic control is suboptimal in many individuals with type 2 diabetes. Although use of flash continuous glucose monitoring (CGM) has demonstrated A1C reductions in patients with type 2 diabetes treated with a multiple daily injection or insulin pump therapy regimen, the glycemic benefit of this technology in patients with type 2 diabetes using nonintensive treatment regimens has not been well studied.METHODSThis retrospective, observational study used the IBM Explorys database to assess changes in A1C after flash CGM prescription in a large population with suboptimally controlled type 2 diabetes treated with nonintensive therapy. Inclusion criteria were diagnosis of type 2 diabetes, age <65 years, treatment with basal insulin or noninsulin therapy, naive to any CGM, baseline A1C ≥8%, and a prescription for the FreeStyle Libre flash CGM system during the period between October 2017 and February 2020. Patients served as their own control subject.RESULTSA total of 1,034 adults with type 2 diabetes (mean age 51.6 ± 9.2 years, 50.9% male, baseline A1C 10.1 ± 1.7%) were assessed. More patients received noninsulin treatments (n = 728) than basal insulin therapy (n = 306). We observed a significant reduction in A1C within the full cohort: from 10.1 ± 1.7 to 8.6 ± 1.8%; Δ −1.5 ± 2.2% (P <0.001). The largest reductions were seen in patients with a baseline A1C ≥12.0% (n = 181, A1C reduction −3.7%, P <0.001). Significant reductions were seen in both treatment groups (basal insulin −1.1%, noninsulin −1.6%, both P <0.001).CONCLUSIONPrescription of the flash CGM system was associated with significant reductions in A1C in patients with type 2 diabetes treated with basal insulin or noninsulin therapy. These findings provide evidence for expanding access to flash CGM within the broader population of people with type 2 diabetes.

399 Simple basal insulin regimen in women with mild gestational diabetes

Approximately 30% to 40% of women with gestational diabetes (GDM) receive insulin therapy, and the multiple daily insulin injection (MDI) regimen with a combination of basal and prandial insulin is generally used, as in cases of prepregnancy diabetes. We developed a simple insulin injection (SII) regimen, in which one or two injected doses of basal insulin are used, for women with mild GDM who require insulin therapy. The present study explored whether or not the SII regimen is as effective as the MDI regimen in preventing fetal macrosomia in women with mild GDM. In this retrospective study, we included singleton pregnant women with GDM in a tertiary perinatal care center. Insulin therapy was indicated if glucose control did not reach the target values under diet therapy. At the beginning of the insulin therapy, we used one daily injection of NPH insulin (10 to 20 units) before breakfast and added another injection of NPH insulin at bedtime, if necessary. If the control still did not reach the target values, we switched to an MDI regimen with additional prandial insulin aspart injection. We compared the glucose control levels, gestational weight gain (GWG), and perinatal outcomes between the diet-alone, SII, and MDI groups. Among 397 women with GDM, 66%, 15%, and 19% were in the diet-alone, SII, and MDI groups, respectively. There were no significant differences in the glucose control, maternal GWG, or perinatal outcomes among the groups (Table). Among the 34% of women with GDM requiring insulin therapy, 44% had a well-controlled condition with the SII regimen without any increase in the GWG or adverse perinatal outcomes. In women with mild GDM requiring insulin therapy, nearly half can maintain good control with this simpler insulin regimen.

Clinical Evaluation of Basal-Bolus Therapy Delivered by the V-Go® Wearable Insulin Delivery Device in Patients with Type 2 Diabetes: A Retrospective Analysis.

Insulin therapy is frequently required to achieve glycemic targets (A1c) in type 2 diabetes (T2D); however, clinicians and patients face barriers with the complexities of multiple daily injection regimens. Patch-like wearable insulin devices, such as V-Go, may simplify and optimize this complexity. This study evaluated the change in A1C and insulin total daily dose (TDD) in a suboptimally-controlled (not achieving A1C targets) T2D population after switching to V-Go. A retrospective chart analysis at a diabetes clinic was performed to evaluate change in A1c measurements from baseline (V-Go initiation) to end of study observation. Of the 139 patients enrolled, A1C significantly decreased from baseline (−1.5 ± 1.79%; p < 0.001). Patients prescribed insulin at baseline (n = 122) used significantly less insulin TDD (−8 u/day; p = 0.006). The percentage of patients meeting the target of A1C < 8% increased from 14% at baseline to 48% at study completion (p = 0.008). Patients prescribed a basal-bolus regimen prior to V-Go achieved an A1C reduction of 1.5 ± 2.0% (p < 0.0001) and experienced the greatest reduction in TDD (−24 u/day; p < 0.0001). Thus, patients switching to V-Go from a variety of therapies at baseline experienced reductions in A1C while using less insulin, with a reduction in clinically relevant hypoglycemia, indicating the potential benefit of V-Go in optimizing and simplifying T2D care.

Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.

OBJECTIVEThe principle of replacing prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA) for type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with albiglutide.RESEARCH DESIGN AND METHODSIn this treat-to-target study, basal plus prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently, lispro injections were fully discontinued 4 weeks later) (n = 402) or to continued optimized lispro plus optimized glargine (n = 412).RESULTSMean ± SD HbA1c at baseline, 7.8 ± 0.6% (61 ± 7 mmol/mol) in the albiglutide + glargine group and 7.7 ± 0.6% (60 ± 7 mmol/mol) in the lispro + glargine group, was reduced at week 26 to 6.7 ± 0.8% (49 ± 8 mmol/mol) and 6.6 ± 0.8% (48 ± 8 mmol/mol), respectively (least squares [LS] difference 0.06% [95% CI −0.05 to 0.17]; noninferiority P < 0.0001). In the albiglutide + glargine group, 218 participants (54%) replaced all prandial insulin without reintroducing lispro up to week 26. Total daily prandial insulin dose was similar at baseline but was lower by 62 units/day (95% CI −65.9 to −57.8; P < 0.0001) at week 26 in the albiglutide + glargine group, and the total number of weekly injections was also reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred in the albiglutide + glargine group with meaningful weight differences (LS mean ± SE −2.0 ± 0.2 vs. +2.4 ± 0.2 kg; P < 0.0001) vs. lispro + glargine. Gastrointestinal adverse events were higher with albiglutide + glargine (26% vs. 13%).CONCLUSIONSA once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal plus prandial insulin treatments and achieve better outcomes in type 2 diabetes.

1044-P: The Impact of Basal Insulin Type, Prandial Dosing Plan, and Baseline Postprandial Glucose (PPG) on Glycemic Control after Treatment with Ultra-Rapid Lispro (URLi) or Humalog in Type 1 Diabetes: Planned Subgroup Analyses from PRONTO-T1D

URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion and improve PPG control. In PRONTO-T1D, a phase 3, 26-week, treat-to-target study comparing URLi to Humalog in patients with T1D on a multiple daily injection regimen with insulin glargine or degludec, mealtime URLi was non-inferior to mealtime Humalog for change from baseline HbA1c and superior for PPG control, with a similar safety profile to Humalog. Randomization to treatment was stratified by basal insulin type, baseline HbA1c and prandial insulin dosing plan (carb counting, yes/no). The impact of these subgroups and baseline 2-hour PPG on the efficacy and safety of URLi was assessed from the double-blind treatment groups: mealtime URLi (n=451) and mealtime Humalog (n=442). No significant treatment-subgroup interactions were noted (all p&amp;gt;0.1) but occasional treatment differences were seen within each subgroup (p&amp;lt;0.05) (Table 1.). Numerically, results suggest that basal insulin type, starting PPG, and starting HbA1c, but not prandial dosing plan, may influence the magnitude of the HbA1c improvement and/or hypoglycemia risk reduction among patients treated with URLi. Disclosure J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company. J. Cho: None. T. Hardy: Other Relationship; Self; Eli Lilly and Company. Funding Eli Lilly and Company

197-OR: Six Months Experience on Hybrid Closed-Loop System in Children and Adolescents Previously Treated with Multiple Daily Injections

Aim: Evaluation of six months experience on MiniMed 670G Hybrid Closed Loop (HCL) system in patients with type 1 diabetes (T1D), previously treated with Multiple Daily Injections (MDI). Methods: This is a 6-months prospective observational study of patients (7 to 18 years) with T1D on MDI, starting the MiniMed 670G system, using a 10-day initiation protocol: 2-days, HCL system assessment; 5-days, HCL system training (2-hours sessions in 5 consecutive days); 3-days, Manual Mode use of HCL system and 6 months, Auto Mode use of the HCL system. Results: MiniMed 670G was initiated in 47 patients (age 12.2±3.2 years). All patients used the system for six months period. Auto Mode usage was 87.2% at the first month and 89.6% at the 6-months of Auto Mode initiation. The mean HbA1c decreased from 8.4±1.5% (68±16.4 mmol/mol) at baseline, 6.7±0.8% (50±8.7 mmol/mol) at 3-months (p=0.021), to 6.9±0.7% (52±7.7 mmol/mol) at 6-months of MiniMed 670G initiation (p=0.024). Time in Range (70-180mg/dL) significantly increased over the time (Figure 1). No severe hypoglycemia nor DKA were found. Conclusion: Children and adolescents with T1D can successfully initiate the HCL system, achieve and maintain better glycemic control than previous MDI regimen. Low attrition rate and the sustainability of the results are likely due to patients’ selection, structured educational program and HCL system by itself. Disclosure G. Petrovski: None. J. Campbell: None. F. AlKhalaf: None. F. Umer: None. K. Hussain: None.

Factors Beyond Carbohydrate to Consider When Determining Meantime Insulin Doses: Protein, Fat, Timing, and Technology.

For many years, carbohydrate counting has been a popular strategy for determining mealtime insulin doses for people with diabetes who are on a multiple daily injection regimen or continuous subcutaneous insulin infusion. This approach assumes that only carbohydrate-containing foods and beverages affect postprandial glucose levels. However, many studies have indicated that the fat and protein content of a meal can play an important role in delaying postprandial hyperglycemia and should be considered when trying to optimize postprandial glucose levels. This article reviews research on making insulin dose adjustments for high-fat and high-protein meals, as well as the timing of mealtime insulin doses.

Combined continuous glucose monitoring and subcutaneous insulin infusion versus self-monitoring of blood glucose with optimized multiple injections in people with type 1 diabetes: A randomized crossover trial.

To investigate the efficacy of a combination of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) versus an optimized degludec-based multiple daily injections (MDI) regimen + self-monitoring of blood glucose (SMBG) in people with type 1 diabetes with regard to optimizing glucose control. The trial included 28 individuals who underwent a 4-week run-in phase, and were then randomized 1:1 to: (a) CSII + CGM followed by MDI + SMBG or (b) an MDI basal-bolus regimen followed by CSII + CGM. In patients randomized to the CSII + CGM → MDI + SMBG arm, a significant reduction in glycated haemoglobin (HbA1c) versus baseline was found at the end of the first phase (CSII + CGM) without significant variation in the following MDI + SMBG phase. In the arm randomized to the MDI + SMBG → CSII + CGM sequence, a significant improvement in HbA1c was observed in the first phase (MDI + SMBG), together with a further decrease in the following CSII + CGM phase. In the comparison of the two treatments using a mixed linear model, CSII + CGM was superior to MDI + SMBG with respect to change in HbA1c (P = 0.001). This study suggests that CSII + CGM improves glycaemic control without relevant safety issues in type 1 diabetes, in comparison with MDI + SMBG.

Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review.

Here, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM). Most patients with T1DM should follow a regimen of multiple daily injections of basal/bolus insulin, but those not meeting individual glycemic targets or those with frequent or severe hypoglycemia or pronounced dawn phenomenon should consider continuous subcutaneous insulin infusion. The latter treatment modality could also be an alternative based on patient preferences and availability of reimbursement. Continuous glucose monitoring may improve glycemic control irrespective of treatment regimen. A glycemic target of glycated hemoglobin < 7% (53 mmol/mol) is appropriate for most nonpregnant adults. Basal insulin analogues with a reduced peak profile and an extended duration of action with lower intraindividual variability relative to neutral protamine Hagedorn insulin are preferred. The clinical advantages of basal analogues compared with older basal insulins include reduced injection burden, better efficacy, lower risk of hypoglycemic episodes (especially nocturnal), and reduced weight gain. For prandial glycemic control, any rapid-acting prandial analogue (aspart, glulisine, lispro) is preferred over regular human insulin. Faster-acting insulin aspart is a relatively new option with the advantage of better postprandial glucose coverage. Frequent blood glucose measurements along with patient education on insulin dosing based on carbohydrate counting, premeal blood glucose, and anticipated physical activity is paramount, as is education on the management of blood glucose under different circumstances.Plain Language Summary: Plain language summary is available for this article.

Diminished school-based support for the management of type 1 diabetes in adolescents compared to younger children.

To evaluate diabetes management at school in a large cohort of adolescents with type 1 diabetes and to compare the level of support provided to adolescents with that provided to younger children. Questionnaires were distributed to adolescents with type 1 diabetes attending nine regional and tertiary paediatric diabetes services in the Republic of Ireland. The data collected included patient demographics, treatment regimen and support provided for self-care management. Results were compared with a similar cohort of primary school children with type 1 diabetes, studied using similar methodology. The study cohort comprised 405 adolescents with a median age of 15 years, of whom 215 (54%) were on multiple daily injections and 128 (32%) were on pump therapy. Eighty-five percent of pump users administered their bolus insulin in classrooms, whereas 76% of those on a multiple daily injection regimen injected outside the classroom. Girls were less likely to administer bolus insulin in an office (10% vs 19%) and more likely to administer it in the bathroom (50% vs 34%; P=0.01). Twenty-five adolescents (12%) on multiple daily injection regimens did not administer bolus insulin at school. Compared to primary school children with type 1 diabetes, adolescents were less likely to use pump therapy, have an emergency treatment plan and have a designated staff member responsible for care needs. Support provided to adolescents with type 1 diabetes is diminished compared with that provided to younger schoolchildren.

Simplifying Complex Insulin Regimens While Preserving Good Glycemic Control in Type 2 Diabetes.

IntroductionType 2 diabetic patients suffering from severe hyperglycemia are often assigned a regimen involving multiple daily injections (MDI) of insulin. If the glucose toxicity resolves, the regimen can potentially be simplified, but there are no guidelines for this, and many patients are left on the MDI regimen. We aimed to prospectively examine the safety and efficacy of switching from MDI to once-daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c ≤ 7.5%) subjects with type 2 diabetes on a low total daily insulin dose (TDD).Methods62 adults with type 2 diabetes (baseline age 64.06 ± 10.24 years, HbA1c 6.42 ± 0.68%, BMI 33.53 ± 6.90 kg/m2, body weight 93.81 ± 19.26 kg, TDD 43.31 ± 10.99 IU/day, insulin requirement 0.47 ± 0.13 IU/kg, duration of diabetes 10.84 ± 7.50 years, mean ± SD) treated with MDI ± metformin were enrolled in our study. Previous insulins were stopped and once-daily IDegLira was started. IDegLira was titrated by the patients to achieve a self-measured pre-breakfast blood glucose concentration of < 6 mmol/L.ResultsAfter a mean follow-up period of 99.2 days, mean HbA1c had decreased by 0.30% to 6.12 ± 0.65% (p < 0.0001), body weight had decreased by 3.11 kg to 90.70 ± 19.12 kg (p < 0.0001), and BMI had reduced to 32.39 ± 6.71 kg/m2 (p < 0.0001). After 3 months of treatment, the mean dose of IDegLira was 20.76 ± 6.60 units and the mean insulin requirement had decreased to 0.23 ± 0.08 IU/kg. IDegLira ± metformin combination therapy was found to be safe and generally well tolerated. During the month before the baseline visit, 28 patients (45%) had at least one episode of documented or symptomatic hypoglycemia, while only 6 (9.67%) patients reported a total of 13 documented episodes during the follow-up.ConclusionIn everyday clinical practice, switching from low-dose MDI to IDegLira in patients with well-controlled type 2 diabetes is safe, may result in weight loss and similar or better glycemic control, and substantially reduces the insulin requirement. Simplifying complex treatment regimens decreases treatment burden and may improve adherence to therapy.Clinical Trial NumberNCT04020445.

Continuous vs. Intermittent Insulin Delivery in Children and Adolescents with Type 1 Diabetes Mellitus

This multicenter, open label, parallel group, randomized controlled trial was conducted to compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes mellitus (T1DM) in children and adolescents (7 mo – 15 y) in UK. A total of 294 participants with a new diagnosis of T1DM were randomized, stratified by age and treating center, to start treatment with CSII (n=145) or MDI (n=149) within 14 days of diagnosis. Primary outcome was glycemic control, as measured by glycated hemoglobin (HbA1c), at 12 months. At 12 months, mean HbA1c was comparable with clinically unimportant differences between CSII and MDI participants (60.9 mmol/mol vs 58.5 mmol/mol; mean difference 2.4 mmol/mol; 95% CI -0.4 to 5.3; P=0.09). Achievement of HbA1c lower than 58 mmol/mol was low among the two groups (66/143 (46%) CSII participants vs. 78/142 (55%) MDI participants (RR 0.84; 95% CI 0.67 to 1.06). Parents (but not children) reported superior pediatric quality of life inventory scores for those patients treated with CSII compared to those treated with MDI. The authors concluded that during the first year following diagnosis of T1DM, no clinical benefit of CSII over MDI was identified in children and young people in the UK setting, and treatment with either regimen was suboptimal in achieving HbA1c thresholds. CSII was not cost-effective.

Long-term body weight trajectories and metabolic control in type 1 diabetes patients on insulin pump or multiple daily injections: A 10-year retrospective controlled study

Background and aimsOverweight/obesity is a clinical concern also in patients with Type 1 diabetes (T1DM). These patients' body weight may vary depending on whether treatment consists in continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI), as these treatments lead to different blood glucose control, insulin doses, and eating behaviors. We compared long-term body weight trajectories in persons with diabetes on CSII or MDI regimens. Methods and resultsAnnual changes in body weight, HbA1c, and daily insulin doses over 6–10 years were retrospectively analyzed in T1DM adult patients on CSII (n = 90) or MDI (n = 90), strictly matched for sex, age, BMI, and diabetes duration. Mean follow-up was 9.1 ± 1.4 years. Body weight increased linearly (∼0.5 kg per year) throughout the observation period (p = 0.001, repeated measures ANOVA) with no significant difference between the CSII and MDI cohorts (p = 0.74), in either normal-weight or overweight/obese patients. HbA1c over follow-up was lower with CSII than with MDI (p = 0.037), maintaining the initial reduction after starting pump therapy. Insulin doses over follow-up were stably lower than baseline (∼20%) with CSII, while linearly increasing (∼20% from baseline to the end of observation) with MDI (p = 0.002). Mean annual weight changes correlated directly with total insulin dose changes (r = 0.191; p = 0.011) and baseline HbA1c level (r = 0.267; p = 0.001), and inversely with HbA1c changes (−0.173; p = 0.021) and baseline age (r = −0.254; p = 0.001). ConclusionT1DM patients on CSII or MDI showed comparable body weight gain over a 10-year follow-up, despite improved glycemic control and decreased insulin doses with CSII.

129-LB: Similar Efficacy, Safety, and Immunogenicity in People with Diabetes Using SAR341402 or Insulin Aspart: Gemelli 1 Study

SAR341402 (SAR-Asp) was developed as a biosimilar/follow-on product to rapid-acting insulin NovoLog®/NovoRapid® (NN-Asp). This 6-month randomized, controlled, open-label, phase 3 study compared efficacy and safety of SAR-Asp and NN-Asp in adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) also using insulin glargine (GLA100) as basal insulin. In total 597 adults with diabetes were randomized (1:1; 497 with T1D, 100 with T2D) to a multiple daily injection regimen of SAR-Asp or NN-Asp along with using once daily GLA100. Glucose targets levels were &amp;lt;180 mg/dL (2h-postprandial) and 80-130 mg/dL (fasting and pre-prandial) while avoiding hypoglycemia. Primary endpoint was HbA1c change (non-inferiority margin of 0.3%) from baseline to week 26 (tested for non-inferiority of SAR-Asp vs. NN-Asp). Immunogenicity was assessed by anti-insulin aspart antibody (AIA) status (positive/negative) and titers during the study. SAR-Asp was non-inferior to NN-Asp for change in HbA1c, with similar insulin dosages. There was no difference in the percentage of patients reporting hypoglycaemia. Immunogenicity and safety profiles (adverse events, hypersensitivity events and injection site reactions) were similar for SAR-Asp and NN-Asp (Table). We conclude that biosimilar/follow-on SAR-Asp is safe, effective and well-tolerated as insulin aspart in adults with T1D or T2D. Disclosure S.K. Garg: Advisory Panel; Self; Eli Lilly and Company, Roche Pharma, Sanofi-Aventis, Zealand Pharma A/S. Research Support; Self; Eli Lilly and Company, WebMD. K. Wernicke-Panten: Employee; Self; Sanofi-Aventis Deutschland GmbH. M. Wardecki: Employee; Self; Sanofi Research &amp; Development. Stock/Shareholder; Self; Sanofi. D. Kramer: Employee; Self; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Self; Sanofi-Aventis Deutschland GmbH. F. Delalande: None. V.N. Shah: Advisory Panel; Self; Sanofi US. Consultant; Self; Dexcom, Inc. E. Franek: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Novartis AG, Novo Nordisk Inc. Speaker’s Bureau; Self; AstraZeneca, Bioton, Boehringer Ingelheim International GmbH, Medtronic, Novartis AG, Novo Nordisk Inc., Polfa Tarchomin S.A. K. Sadeharju: Research Support; Self; AstraZeneca, Bayer AG, ICON plc., Sanofi. T. Monchamp: Research Support; Self; Amarin Corporation, Novo Nordisk Inc., Sanofi, TrialNet. Funding Sanofi

Continuous subcutaneous insulin infusion versus multiple daily injection regimens in children and young people at diagnosis of type 1 diabetes: pragmatic randomised controlled trial and economic evaluation

ObjectiveTo compare the efficacy, safety, and cost utility of continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) regimens during the first year following diagnosis of type 1 diabetes...

The role of proper insulin injection technique training FOR achieving of good glycaemic control

Inappropriate injection technique leads to incorrect insulin dosing, increased pain and impaired glucose control in patients with diabetes. This review examines in detail the results of two clinical studies, the Glycemic Impact of Insulin Injection Technique (GIIIT) and the UK Lipo Study (UKLS) that examined the effect of teaching patients proper injection techniques to achieve good glycemic control.&#x0D; The GIIIT study included patients with type 1 and type 2 diabetes (1870 years) who were on a regimen of multiple daily insulin injections. They were categorised into three groups: those that received structured injection technique training using 4-mm injection needles (TN), those that received injection technique training (T) and control (C). The UKLS study included 75 patients who received structured training to reduce the risk of developing lipohypertrophy.&#x0D; Initially, deviations from proper insulin injection technique were observed in a majority of patients in both the studies. In the GIIIT study, 6 months after training under TN and T conditions, HbA1c decreased by 1%, with no observable changes under the C condition. The daily insulin dose was increased by 6 IU in all conditions. Overall, the use of 4-mm short needles reduced post-injective pain in all patients. In the UKLS study, for 6 months, the variability of glycemia and frequency of unexplained hypoglycaemia decreased as the daily dose of insulin decreased by an average 6 IU; in addition, HbA1c level decreased from 8.6% to 8.2%. Six months after the training, both studies noted a decrease in or disappearance of lipohypertrophy in the patients.&#x0D; These results indicate that proper injection technique training improves glycemic control in patients with diabetes.