Insulin Dose Titration Research Articles

Type 1 Diabetes Mellitus Associated with Dermatomyositis: A Case Report

Abstract Type 1 diabetes mellitus (T1DM) is an autoimmune illness that targets specific organs and associated with other autoimmune conditions. Dermatomyositis is an idiopathic systemic autoimmune condition involving skeletal muscles and skin. Co-occurrence of both disorders is quite rare. We diagnosed dermatomyositis in a young male with T1DM who presented with muscle weakness and cutaneous manifestations. There is an additional metabolic hurdle in T1DM, as high doses of glucocorticoids used in dermatomyositis management are related to glycemic instability which requires regular blood sugar monitoring and insulin dose titration accordingly. Considering the prognostic consequences, early diagnosis and management of dermatomyositis is essential.

Efficacy of a basal insulin dose management smartphone application for controlling fasting blood glucose in patients with type-2 diabetes mellitus: A single-centre, randomised clinical study.

To explore the efficacy and safety of the 'Walk with you'application for titrating basal insulin (BI) doses in type-2 diabetes mellitus (T2DM) hospitalised patients. This was a randomised, single-centre, open-label, controlled clinical trial to compare the changes in fasting blood glucose (FBG) and postprandial blood glucose (PBG), time to reach target FBG (FBG-TRT), incidence of hypoglycaemia events and FBG coefficient of variation in the application group (weight-based titration of BI dose regimen) and control group (typical adjustment regimen). This study selected 173 patients with T2DM using basal-prandial insulin therapy who were admitted to Binhaiwan Central Hospital of Dongguan between December 2021 and December 2022. Patients were randomised to the control group or the application group (App group) and then titrated to achieve an FBG concentration of less than 7.0 mmol/L. There were 86 patients in the control group and 87 patients in the App group. The FBG concentrations in the control and App groups were decreased by 6.77 ± 4.75 and 5.95 ± 4.06 mmol/L, respectively. The FBG-TRTs in the control and App groups were 3.80 ± 1.52 and 2.82 ± 1.34 days, respectively (p < .001). Fewer patients in the control group reached the FBG-TRT within 3 days than in the App group, with 46.5% and 71.3% of patients reaching that target, respectively. There was no significant between-group difference in hypoglycaemia incidence. The use of this weight-based insulin dose titration protocol for BI app is effective and safe for achieving the target FBG in noncritically ill patients with T2DM and is free, easy to use and user friendly.

Studies are needed to support optimal insulin dose titration in gestational diabetes mellitus: A systematic review

Background and aimsWe aimed to summarise the existing literature on insulin dose titration in gestation diabetes. MethodsDatabases: Medline, EMBASE, CENTRAL and CINAHL were systematically searched for trials and observational studies comparing insulin titration strategies in gestational diabetes. ResultsNo trials comparing insulin dose titration strategies were identified. Only one small (n = 111) observational study was included. In this study, patient-led daily basal insulin titration was associated with higher insulin doses, tighter glycaemic control, and lower birthweight, vs weekly clinician-led titration. ConclusionsThere is a paucity of evidence to support optimal insulin titration in gestational diabetes. Randomized trials are required.

Basal insulin titration algorithms in patients with type 2 diabetes: the simplest is the best (?)

Basal insulin is the first and main component of insulin therapy in patients with type 2 diabetes mellitus (T2DM). Based on the shortcomings of human NPH insulin and the advantages provided by long-acting basal insulin analogues, they are recommended for priority use in patients with T2DM. The leading factor in the success of insulin therapy is titration of its dose with the achievement of the target range of glycemia. Data from clinical trials and real clinical practice indicate that simpler dose titration algorithms ensure better achievement of glycemic goals with a lower risk of hypoglycemia. In addition, simple dose titration algorithms are better accepted by patients and increase satisfaction with treatment. The leading societies of diabetologists ADA/EASD and AACE/ACE recommend the use of simple dose titration algorithms. Recent clinical trials on the effectiveness of the insulin glargine dose titration based on the INSIGHT algorithm, which, unlike the traditional options for changing the dose 1–2 times a week, involves a daily correction of the insulin glargine dose by 1 Unit, have proven its effectiveness and safety. Most patients prefer this type of insulin dose titration. The same titration algorithm can be used for a fixed combination of glargine with lixisenatide, which was also confirmed by the results of clinical trials. In general, simplified options for correcting the basal insulin dose have demonstrated their effectiveness and allow increasing the percentage of patients who manage to achieve the glycemic goal without increasing the risk of hypoglycemia. When prescribing basal insulin, physician must determine the target range of glycemia, demonstrate the titration algorithm that is acceptable for each insulin and which a patient will use to achieve the glycemic goal.

Expert Opinion by Clinicians on the Use of Insulin Therapy in People with Hepatic Impairment.

People with type 2 diabetes mellitus (T2DM) have a higher risk of developing chronic liver disease (CLD) and its complications. T2DM, obesity, and insulin resistance are all strongly associated with nonalcoholic fatty liver disease (NAFLD). Conversely, people suffering from cirrhosis have reduced glucose tolerance in approximately 60% of cases, diabetes in 20% of cases, and insulin-mediated glucose clearance is lowered by 50% as compared with those who do not have cirrhosis. An exploratory review was conducted using existing published evidence from clinical studies on dosing and titrations of individual insulin formulations in people with CLD to optimize insulin dosage titration for minimizing hypoglycemia risk.pThis article discusses current hyperglycemia treatment techniques for patients with CLD as well as the consensus recommendations on insulin use in special populations with T2DM and hepatic impairment. Based on available evidence and expert diabetologists' recommendations, careful insulin dose titration, customized glycemic targets, and frequent glucose screening are recommended for optimal glycemic management without hypoglycemia in CLD. Long-acting insulin should be avoided or used when short-acting insulin fails to provide adequate glycemic control with raised fasting blood sugar levels. While the patient's glucose profile is being evaluated, the prandial insulin dose can be lowered by 25% initially. The dose can be titrated based on the patient's postprandial glycemic expression and whether their food intake meets the Child-Pugh scores A and B categories. Titrating premixed insulins is difficult for patients in class C since their appetite and overall health are constantly compromised and in flux.

Predictors of success and failure in achieving glycemic control targets in patients with type 2 diabetes on basal insulin: review of the real-world evidence studies

Basal insulin (BI) is the main therapeutic option for patients with type 2 diabetes (T2D) who have not reached glycemic targets on oral antidiabetic drugs and/or glucagon-like peptide-1 receptor agonists. The results of epidemiological studies indicate that the majority of patients with T2D do not achieve the targeted parameters of glycemic control on BI in the real-world settings. In this review the results of real-world evidence studies assessing predictors of success or failure of BI therapy in patients with T2D are we summarized. A number of studies have demonstrated that delayed initiation of insulin therapy with a high level of glycated hemoglobin A1c (HbA1c) at the start of the treatment reduces achieving glycemic control targets on BI. Hypoglycemia in the first weeks or months of BI treatment may reduce the adherence and persistence to treatment and likelihood of achieving treatment targets. In real-world evidence studies, glargine 300 U/mL and degludec, the long-acting second-generation insulin analogues, have shown greater potential in reduction of HbA1c levels with a lower risk of hypoglycaemia compared to other BIs. In the DUNE, ATOS, and some others studies, a lack of insulin dose titration in newly initiated BI users and those who needed treatment intensification was demonstrated. Poor treatment adherence and persistence (missed injections, incorrect dose selection, and temporary or permanent discontinuation of insulin therapy), deviations in insulin injection technique, and formation of lipohypertrophy at the injection sites are also common problems that prevent good glycemic control in these patients. Therefore, patient education with a focus on injection technique, dose titration and prevention of hypoglycemia, as well as the use of the second-generation BI analogs, increases the chances for achieving glycemic control targets in patients with T2D who initiate or need to intensify BI therapy.

Comparison of Once-daily Versus Twice-daily Injection of Insulin Detemir in Children with Type 1 Diabetes Mellitus

Background: The purpose of this study was to compare the effectiveness of once-daily versus twice-daily insulin detemir injection in children with type 1 diabetes mellitus (T1DM). Methods: In this randomized 4-month clinical trial, 60 children aged 33 - 156 months with T1DM were randomly assigned into two groups, once-daily (group 1) and twice-daily (group 2) detemir insulin injection with pre-meal insulin Aspart. The first month of the study was devoted to educating the patients and insulin dose titration. Hemoglobin A1C (HbA1C) measured at the end of the first month and again after the fourth month. Hypoglycemia as one of the major complications was defined as blood glucose lower than 70 mg/dL with clinical symptoms or blood glucose lower than 50 mg/dL in the absence of clinical symptoms. Results: Mean HbA1C in the fourth month was 8.5% ± 1% in group 1 and 8.5% ± 1.1% in group 2 (P = 0.98). Mean changes in the fourth month compared to baseline were -0.09% (95% CI: -0.47 - 0.3) in group 1, and -0.42% (95% CI: -0.94 - 0.09) in group 2 (P = 0.273). The treatment modification rate was 39% and 15% in groups 1 and 2, respectively (P = 0.02). However, there were no statistically significant differences between the two groups in terms of insulin dose, hypoglycemia, and other complications. Conclusions: Twice-daily injections did not change HbA1c in comparison with once-daily injections. However, the lower treatment modification rate in the twice-daily group in the age group of our study was considerable.

Exploring the Experiences and Perspectives of Insulin Therapy in Type 2 Diabetes via Web-Based UK Diabetes Health Forums: Qualitative Thematic Analysis of Threads.

BackgroundDespite the advent of type 2 diabetes (T2D) remission strategies and novel therapeutic agents, many individuals with T2D will require insulin treatment to achieve target glycemia, with the aim of preventing or delaying diabetes complications. However, insulin refusal and cessation of treatment in this group are common, and their needs are underreported and relatively unexplored.ObjectiveThis study aimed to explore the experiences and perspectives of individuals with T2D for whom insulin therapy is indicated as expressed on web-based health forums, in order to inform the development of evidence-based structured educational and support strategies and improve health care provider awareness.MethodsRetrospective archived forum threads from the 2 largest, freely and publicly accessible diabetes health forums in the United Kingdom were screened over a 12-month period (August 2019-2020). The Diabetes UK and Diabetes.co.uk forums were searched for relevant threads. A total of 3 independent researchers analyzed the forum threads and posts via thematic analysis. Pertinent themes were identified and illustrated by paraphrasing members’ quotes to ensure anonymity. A total of 299 posts from 29 threads from Diabetes UK and 295 posts from 28 threads Diabetes.co.uk were analyzed over the study period. In all, 57 threads met the inclusion criteria and were included in the final analysis.ResultsFour overarching themes were generated to illustrate the unmet needs that prompted members to seek information, advice, and support regarding insulin therapy outside of their usual care provision via the forums: empowerment through sharing self-management strategies, seeking and providing extended lifestyle advice, relationships with health care professionals, and a source of psychological peer support.ConclusionsThis is the first study to collect data from web-based health forums to characterize the experiences and perspectives of people with T2D for whom insulin therapy is indicated. The observed naturalistic conversations have generated useful insights; our findings suggest that there are significant unmet self-management and psychological needs within this group that are not being met elsewhere, prompting the seeking of information and support on the web. These include practical aspects such as insulin injection technique, storage and dose titration, driving and travel considerations, the emerging use of technology, and a strong interest in the effects of extended lifestyle (diet and activity) approaches to support insulin therapy. In addition, problematic relationships with health care professionals appear to be a barrier to effective insulin therapy for some. In contrast, seeking and offering mutually beneficial, practical, and psychological support from peers was viewed as enabling. The study results will help to directly inform insulin-focused self-management and support strategies to enable individuals in this group to achieve their best outcomes.

Patient-led rapid titration of basal insulin in gestational diabetes is associated with improved glycaemic control and lower birthweight.

AimsElevated fasting blood glucose in gestational diabetes (GDM) is a key predictor of high birthweight babies and adverse pregnancy outcomes but is hard to treat. We implemented a simple, patient‐led, insulin dose titration algorithm aiming to improve fasting glycaemic control in GDM.MethodsIn women with GDM, initiating basal insulin, we recommended a daily four‐unit dose increase after every fasting glucose value ≥5.0 mmol/mol (90 mg/dl). This approach augmented our pre‐existing intensive (weekly) specialist nursing input. Using a before‐and‐after retrospective observational study design, we examined insulin doses and glucose values at 36 weeks gestation and maternal and neonatal outcomes in 105 women completing pregnancy before and 93 women after the intervention.ResultsThe baseline characteristics of women in the before and after groups were the same. Women initiated on insulin after implementation (n = 30 before, n = 43 after) achieved substantially higher doses at 36 weeks (53 vs. 36 units/day; 0.56 vs. 0.37 units/kg/day; p = 0.027). 36‐week mean fasting glucose was lower in those on insulin after implementation (4.6 vs. 5.1 mmol/L [83 vs. 92 mg/dl]; p = 0.031). Birthweight was significantly reduced (birthweight Z‐scores 0.34 vs. 0.92; p = 0.005). There was no significant difference in macrosomia (after; 2% vs. before; 17% p = 0.078) or caesarean sections (after; 33% vs. before; 47%; p = 0.116). No women experienced severe hypoglycaemia. There were no outcome differences before versus after intervention in women not treated with insulin.ConclusionsPatient‐led daily insulin titration in gestational diabetes leads to higher insulin dose use lower fasting glucose and is associated with lower birthweight without causing significant hypoglycaemia.

In gestational diabetes, patient‐led insulin titration is rapidly effective, safe and is associated with reduced birthweight

AbstractBackground: Elevated fasting glucose in gestational diabetes (GDM) is the strongest predictor of adverse pregnancy outcomes but is difficult to treat. We assessed the effectiveness, safety, and patient acceptability of a simple patient‐led insulin dose titration algorithm in GDM, targeting rapid reduction in fasting glucose.Methods: Once initiated on basal insulin, women were asked to increase their dose by 4 units daily, following every fasting glucose ≥5.0mmol/L. We evaluated pregnancy outcomes, rates of hypoglycaemia and time taken to achieve target readings (&lt;5.3mmol/L) before and after this practice change. We undertook patient interviews and questionnaires to capture the patient perspective.Results: Insulin was commenced at a median 30+4 weeks with fasting glucose control (defined as the first of three consecutive readings &lt;5.3mmol/L) achieved after a median 4 days (IQR: 1–11) and maintained throughout pregnancy with further patient‐led titrations. Hypoglycaemia was uncommon; 1.7% of all fasting glucose readings were &lt;3.5mmol/L and 0.3% were &lt;3.0mmol/L. No patients experienced hypoglycaemia requiring assistance. At delivery, patient‐led titration achieved higher final insulin doses (53 vs 36 units/day; p=0.027), improved fasting glucose (4.6 vs 5.1mmol/L; p=0.031), and significantly lower birthweight (Z‐scores 0.34 vs 0.92; p=0.005) compared to our previous routine practice. Women liked the intervention and having increased responsibility for their own management.Conclusions: In GDM significant reduction in birthweight is achieved with patient‐led insulin dose titration. Following insulin initiation glycaemic control is achieved rapidly and maintained without detrimental hypoglycaemia. Copyright © 2022 John Wiley &amp; Sons.

64-LB: Long-Term Effectiveness of the My Dose Coach Application on the Maintenance of Glycemic Control in Patients with Type 2 Diabetes Mellitus in Uncontrolled

Introduction: My Dose Coach (MDC) is an app designed for basal insulin dose titration that has demonstrated its versatility in several clinical studies. We evaluated its effect on the maintenance of glycemic control for 28 weeks in patients with type 2 Diabetes. Objective: Compare the efficacy of 2 basal insulin titration strategies: MDC vs. Conventional Titration (CT) to maintain glycemic control (HbA1c &amp;lt; 7% and fasting plasma glucose -FPG- between 90-130 mg/dL) . Research Design and Methods: We design controlled and randomized clinical trial lasting 28 weeks, we included 80 patients with uncontrolled type 2 Diabetes (HbA1c between 8-10%) and without previous treatment with insulin. They were randomized into 2 groups: online insulin dose titration using the MDC app vs. CT in person every 2 weeks. At week 25, all enrolled patients titrated their dose in a conventional manner to assess the effect of discontinuing use of the app. Results: We included 40 patients per group, with a mean age of 52.7 years and a duration of type 2 Diabetes of 8.1 years. A total of 36 subjects (90%) vs. 33 (82.5%) completed the study, p 0.215. In the initial evaluation the following results were obtained: baseline FPG 172 vs. 167 mg/dL, p 0.98, HbA1c 9 vs. 8.9%, p 0.497, initial dose of insulin Glargine (U-100/U-300) 16.9 vs. 17.6 IU, p 0.122, MDC vs. CT respectively. Evaluation at 24 weeks, glucose 106 vs. 110 mg/dL, p 0.69, HbA1c 6.87 vs. 7.08 %, p 0.016, mean HbA1c reduction -2.10 vs. -1.83 %, p 0.015. Final insulin dose 29.9 vs. 34.1 IU, p 0.004, mean time to FPG goal 18 vs. 26 days, p 0.001. When suspending the titration by means of the application in the week 25 to 28 average glucose increased 138.5 vs. 142 mg/dL p 0.605, MDC vs. CT respectively. Conclusions: My Dose Coach app is an effective digital insulin glargine titration tool in real-world patients with uncontrolled type 2 Diabetes, as the number of participants achieving established control goals was higher and lasted longer. Fulfilling the objective of the study with lower doses of insulin and achieving stability in FPG in a considerably shorter time. Disclosure M. A. Polanco: None.

Continuous Glucose Monitoring-Assisted Insulin Dose Titration in the Indian Outpatient Setting

Context: Monitoring blood glucose levels is an important aspect in the overall management of an individual with diabetes mellitus. Continuous glucose monitoring (CGM) system is an effective tool that enables physicians to do so by way of regular automated checks of sensor glucose (SG). Aims: In this article, we discuss in detail on how CGM technology works, practical aspects of its application and how CGM data are interpreted. We describe the different glucose sensors available in India and suggest when and whom to use them. We also evaluate the effectiveness of CGM-assisted titration of insulin dose in our hyperglycemic patients and discuss the results. Settings and Design: This is a single-center retrospective observational study of insulin-treated patients with diabetes attending the endocrinology outpatient department, who opted for a CGM-assisted insulin dose titration. Subjects and Methods: Monitoring was done using the Freestyle libre pro™ CGM system and insulin doses were titrated on regular follow-ups every 3–4 days for a total of 2 weeks. Patients who had an average SG level of more than 250 mg/dl on day 1 of monitoring, and had CGM data for a minimum of 12 days were included (n = 73). Data were analyzed using CGM-specific glucometrics including average SG and estimated A1c (eA1c) reduction, and changes in the percentage time in range (TIR), time below range (TBR), and time above range (TAR). Statistical Analysis Used: Not applicable. Results: When compared to day 1, the last day (D12–14) of CGM-assisted insulin dose titration showed: 1. An average SG reduction of 164.1 mg/dl (321.34 mg/dl → 157.24 mg/dl). 2. An eA1c reduction of 4.98% (12.08% → 7.1%). 3. An average TIR improvement of 51.21% (3.8% → 55.01%). 4. An average TAR reduction of 62.06% (96.12% → 34.06%). 5. An average increase in TBR from 0% to 10.21%. Target TIR &gt;70% was achieved by 31/73 patients on D12-14, compared to 0/73 on day 1. Target TAR &lt;25% was achieved by 43/73 patients on D12-14, compared to 0/73 on day 1. Target TBR &lt;5% was not achieved by 21/73 patients on D12-14 when compared to 0/73 on day 1. Conclusions: CGM is a novel, easy-to-use, useful technology easily available in India for all patients with diabetes. We have demonstrated that quick and effective glycemic reduction is possible with CGM-assisted insulin dose titration within a short period of 2 weeks.

954-P: In Gestational Diabetes, Patient-Led Insulin Titration Is Rapidly Effective without Detrimental Hypoglycaemia

Introduction: Elevated fasting blood glucose in gestational diabetes (GDM) is the strongest predictor of adverse pregnancy outcomes but is difficult to treat. We assessed the effectiveness and safety of a novel patient-led insulin dose titration algorithm, targeting rapid reduction in fasting glucose. Research Design and Methods: In women with GDM commenced on insulin, we initiated a patient-led approach to basal dose titration. Women were asked to increase their basal insulin dose by 4 units after every elevated fasting blood glucose (&amp;gt;90 mg/dL). We retrospectively reviewed the records of 50 women with GDM, after initiating this approach. Daily fasting capillary glucose measurements and insulin dose were collected from GDM diagnosis to delivery. Results: Basal insulin was commenced at a median 30+4 weeks gestation in 28 (56%) women. At insulin initiation median fasting glucose was 104.4 mg/dL. Fasting glucose control (defined as the first of three consecutive readings &amp;lt;95 mg/dL) was achieved by all women after a median 4 days (IQR: 1-13). This was successfully maintained for the remainder of pregnancy with additional patient-led titrations. Basal insulin dose at delivery (median 38+2 weeks gestation) was a median 34 units (IQR 18-62; 0.31 units/kg; IQR 0.23-0.71) with a birthweight less than half a standard deviation above normal (birthweight z-score 0.47 vs. 0.81 [n=34 insulin treated prior to implementation]). Hypoglycaemia &amp;lt;63 mg/dL was uncommon in those on basal insulin (1.86% of all fasting glucose readings) with just five values &amp;lt;54 mg/dL (0.34% of all readings). By comparison, in women never started on basal insulin (n=22), 0.45% of fasting readings were &amp;lt;63 mg/dL with just one value &amp;lt;54 mg/dL (0.09% of all readings). No patients experienced hypoglycaemia requiring assistance. Conclusions: In GDM, fasting glycaemic control is achieved within a week by using intensive patient-led insulin titration and is not at the expense of detrimental hypoglycaemia. Disclosure I. K. Mayne: None. N. Thomas: None. A. T. Hattersley: None. A. P. Mcgovern: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc.

Usage of glucometer with mobile application in real clinical practice

Introduction. Glycemic control in patients with diabetes mellitus type 1 (DM1) can be held using glucometer with mobile application, continuous glucose monitoring (CGM), and intermediately scanned CGM (isCGM). isCGM do not need calibration with glucometer as CGM, but its usage in children and adolescents is recommended only together with glucometer.Aim: to study characteristics of glucometer usage in real clinical practice in a patient which utilizes glucometer with mobile application and is CGM simultaneously.Materials and methods. A 17-year-old girl with diabetes mellitus type 1 was advised to use isCGM together with glucometer Contour Plus One (ISO 15197:2013) and mobile application Contour Diabetes.Results. The first three months, while insulin dose titration and education, the patient used glucometer 1–9 times a day (3.0 (2.0; 4.0)), filled in diary. These led to decrease of glycaemia (10.7 (5.5; 14.7) – 7.8 (5.2; 9.5) mmol/L) and variability (56–45%), increase of percent of measurements within range (38–57%), according to glucometer; decrease of mean glycaemia (11.8–8.5 mmol/L) and increase of time in range (TIR) (14–59%), according to isCGM. The next three months, while diabetes mellitus type 1 compensation, according to glucometer (glycaemia 6.9 (4.9; 9.7) mmol/L, variability 48%, percent of measurements within range 71%) and isCGM (mean glycaemia mean glycaemia 7.3 mmol/L, TIR 67%), the patient stopped to fill in diary, decreased number of measurements by glucometer to 1.0 (1.0; 2.0) times a day. Mean month glycaemia was 5.5–9.8% lower according to glucometer than isCGM. The patient used glucometer in cases with relatively high risk of hypoglycemia more often.Conclusion. Usage of glucometer with mobile application can increase adherence to treatment. If glucometer and isCGM used simultaneously the patients measure glycaemia with glucometer in cases of decompensated diabetes mellitus type 1 and while insulin titration more often. Mean month glycaemia according to glucometer, if used every day, corresponds with isCGM data. We must discuss with patients circumstances when they use glucometer because this can influence glycemic control indicators in mobile application reports.

110-LB: The Korean Titration: A Randomized Controlled Trial to Evaluate the Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 Units/ml in Patients with Uncontrolled Type 2 Diabetes

Background: In the Canadian TITRATION study, the INSIGHT algorithm was as effective as the EDITION algorithm for insulin dose titration in patients with type 2 diabetes. However, these algorithms have not been evaluated in Asian patients. Objective: To compare the efficacy and safety of two algorithms, the INSIGHT and EDITION, for insulin glargine 300 units/mL (Gla-300) in patients with uncontrolled type 2 diabetes treated with basal insulin Methods: The Korean TITRATION was a 12-week, single-center, open-label, randomized, treat-to-target, and pragmatic trial. We randomly assigned 130 patients to either the INSIGHT (self-titration by 1 unit/day) or EDITION (self-titration no more than every 3 days) groups to achieve a fasting self-monitored blood glucose (SMBG) in the range of 4.4 to 5.6 mmol/L. The primary endpoint was a proportion of patients reaching fasting SMBG ≤5.6 mmol/L without hypoglycemia. Results: A total of 129 patients were included in the study. At week 12, patients achieving the primary endpoint were 24.6% (INSIGHT) and 23.4% (EDITION) (P = 0.961). Fasting SMBG were 102.0 mg/dL (INSIGHT) and 111.2 mg/dL (EDITION) (P = 0.110). Proportions of patients with HbA1c ≤7% were 23.1% (INSIGHT) and 20.3% (EDITION) (P = 0.867). There was no difference in changes in fasting plasma glucose, HbA1c, and body weight between the two groups. Mean changes in total daily insulin doses were significantly higher in the INSIGHT group than in the EDITION group (12.83 units/day vs. 6.81 units/day, P = 0.030). However, the incidence of hypoglycemia was comparable between the two groups. In addition, adherence to the algorithm tended to be higher in the INSIGHT group than in the EDITION group (45.7% vs. 35.9%, P = 0.109). Conclusion: The self-titration of Gla-300 with the INSIGHT algorithm is effective and safe compared to that with the EDITION algorithm in Korean patients with uncontrolled type 2 diabetes. Disclosure J. Bae: None. C. Ahn: None. Y. Yang: None. S. Moon: None. S. Kwak: None. H. Jung: None. K. Park: None. Y. Cho: None.

A pragmatic study of mid-mixture insulin and basal insulin treatment in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic medications: A lesson from real-world experience.

BackgroundChinese guidelines for the treatment of type 2 diabetes (T2D) recommend basal or premixed insulins as insulin starters after failed oral antihyperglycaemic medication (OAM). This pragmatic study compared effectiveness and safety of add‐on basal insulin analog (BI) and mid‐mixture insulin analog (MMI; 50:50 premixed insulin) as starter insulin regimens in Chinese patients with T2D in a real‐world setting.Materials and MethodsThis was a multicentre, open‐label, randomized, parallel, pragmatic trial. Patients receiving OAMs were randomized 1:1 to BI (n = 410) or MMI (n = 404) for 24 weeks. Insulin titration and OAM adjustment were determined by investigators following usual standard‐of‐care. The primary outcome was change in glycated haemoglobin (HbA1c) from baseline.ResultsLeast‐squares mean changes in HbA1c from baseline to week 24 were −2.00% and −2.15% for BI and MMI groups, respectively (P = .13). The MMI group demonstrated a greater reduction in concomitant OAM therapies used than BI group (53.8% vs. 35.3%, respectively; P < .001). Very limited daily insulin dose increments were observed from baseline to week 24 in both BI and MMI groups (2.5 U/day and 1.8 U/day, respectively). Although both insulin analogs were well‐tolerated without severe hypoglycaemia, small weight gains were seen with both treatments. Higher total hypoglycaemia rates were noticed with the MMI group, while nocturnal hypoglycaemia events were comparable.ConclusionsIn real‐world settings, BI and MMI provided similar improvement in glucose control without conceding hypoglycaemia. The BI group received a greater number of OAMs in real‐world settings. Limited insulin dose titration was observed, while more adjustments occurred with OAM usage.

Basal Insulin Dose Titration for Glycemic Control in Patients With Type 2 Diabetes Mellitus in Thailand: Results of the REWARDS Real-World Study.

This multicenter, longitudinal, descriptive, observational study of T2DM adults in Thailand aimed to assess real-world outcomes of basal insulin (BI) dose titration on glycemic control. Three-hundred and twenty-four patients were recruited and followed up over 24 weeks. Basal insulin titration was physician-driven in 58.2% of patients and patient-driven in the rest. During the 24-week study period, the total daily BI dose moved from 20.9 to 25.6 in the physician-driven group, while in the patient-driven group, it increased from 25.3 to 29.7. Thirty-five patients (11.2%) achieved their individualized HbA1c targets, with 18 patients (5.8%) achieving HbA1c ⩽ 7% without documented hypoglycemia. In summary, this study highlights that BI titration is suboptimal in the real world, and patients are unable to achieve their glycemic targets.

SGLT inhibitors in type 1 diabetes: weighing efficacy and side effects.

Even before sodium-glucose cotransporter inhibitors (SGLTi) became popular agents for the treatment of people with type 2 diabetes (T2DM), clinicians had explored their potential as adjunct therapies in type 1 diabetes (T1DM). Several trials have demonstrated improved glycemic control (compared with placebo) and a decrease in glucose variability with a clinically relevant increase of time in range. In addition, weight loss and decreased systolic blood pressure are observed. The magnitude of the effects observed depends on the type of SGLTi, the dose administrated, and the duration of observation in the studies. As seen in T2DM, there was an increase in the risk of urogenital mycotic infections, but no increase in the risk of severe hypoglycemia. However, concerns arose regarding an increase in incidence of diabetic ketoacidosis. Mitigation strategies, including careful patient selection, extensive education of patients and (para)medical personnel, adequate insulin dose titration, and the adoption of a ketone-centered approach, are suggested.In different areas of the world, SGLTi are approved for use in T1DM with restrictions concerning patient selection and SGLTi dose. Real-world data on the effect of introduction of SGLTi in people with T1DM will yield insight on the robustness of glycemic effects over time, and allow us to determine whether the positive risk–benefit profile observed in clinical trials can be translated to the real world.

Implementation of Basal–Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with an Insulin Pen

Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen.Methods: Adults with type 2 diabetes (n = 278, age: 59.2 ± 8.9 years), were randomized to patch (n = 139) versus pen (n = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets.Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved (P < 0.0001) in both arms, −1.7% ± 0.1% and −1.6% ± 0.1% for patch and pen (−18.6 ± 1.1 and −17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more (P = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin.Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.

Clinical efficacy of Professional Continuous Glucose Monitoring in improving glycemic control among children with Type 1 Diabetes Mellitus: An Open-label Randomized Control Trial

Frequent self-monitoring of blood glucose (SMBG) is the only accurate method available for insulin dose titration in patients with T1DM. Professional continuous glucose monitoring (p-CGM) is blinded recording of glucose trends over 5–7 days and helps physicians to guide insulin titration to patient. This study was planned to assess efficacy of insulin dose adjustments, based on p-CGM plus SMBG in improving glycemic control compared to SMBG alone. We did an open-label, parallel design, randomized control trial among children (2–10 years) having T1DM for at least 6 months. Subjects in the intervention group were placed on p-CGM (iPRO 2™ Professional CGM, Medtronic, USA) for 3–5 days along with regular SMBG. Data from p-CGM was analyzed by physician and used to guide insulin titration along with SMBG over following 3 months. Control group had only SMBG records for titrating insulin doses. Primary outcome was change in HbA1c 3 months after intervention. A total of 68 eligible children were randomized, 34 each to either arms. Thirty children in intervention group and 33 in control group completed the study and were analyzed. It was found that there was more decreased unit change in HbA1c, percentage of low sugar records and total insulin requirement per day, after 3 months follow-up, in intervention group. However, difference was not significant except for total insulin Units/kg/day (p = 0.014). In sub-group analysis of children with baseline HbA1c >7.5%, there was a significant mean fall of HbA1c by 1.27% (p = 0.045). There were no major adverse events associated with p-CGM. We conclude that addition of p-CGM along with SMBG may help in adjusting insulin dose more effectively especially in children with higher baseline HbA1c.