Effects of Recommendations for Diabetes Management at Hospital Discharge on Long-Term Diabetes Control.

OBJECTIVE: To determine the impact of diabetes-specific recommendations at 1 year after hospital discharge on glycemic control and diabetes care in an outpatient setting. METHODS: A total of 139 patients with type 2 diabetes on a basal-bolus insulin regimen during hospitalization were included in the statistical analysis. We gathered data on treatment regimens after 12 to 16, 26 to 30, and 52 to 56 weeks following discharge as well as glycosylated hemoglobin (HbA1c) levels for all patients. Prescriptions for diabetes therapy were retrieved. All changes in insulin or oral/noninsulin injectable drug regimens were recorded. RESULTS: Half of the patients (n = 69) were discharged on their preadmission regimen (no change), and a change in the home treatment was recommended in the other half (n = 70). In the group of patients whose preadmission therapy was adjusted, HbA1c decreased from 9.6% (80 mmol/mol) to 8.5% (69 mmol/mol) (P = .0004) 1 year after discharge. In the group of patients discharged on their preadmission regimen, no significant changes in HbA1c levels during the study were observed. At follow-ups occurring 12 to 16 weeks after discharge, 52% (95% CI: 37.4%-66.3%) of patients in the change group had their treatment modified, compared with 18.6% (95% CI: 9.7%-30.9%) in the no-change group. In the group of patients discharged on their preadmission regimen, no significant change was observed. At the beginning of the study, patients in the change treatment group had higher HbA1c levels than patients in the no-change group (9.6 ± 2.0 vs 8.6 ± 1.7, P < .001). At the end of the study, no significant changes in terms of HbA1c levels were found between the groups (8.8 ± 1.9 vs 8.5 ± 1.9, P = .2). CONCLUSIONS: Significant improvement in diabetes control occurred 1 year after hospital discharge in patients who underwent modifications in their treatment. This supports the relevance of providing and implementing proper care recommendations at transition.

Initiation of basal bolus insulin therapy.

Most practice guidelines recommend the use of longacting or pre-mixed insulin at the initiation of insulin therapy in type 2 diabetes, especially in patients not achieving glycaemic goals. Nonetheless, there are some specific indications where basal bolus insulin is the preferred regimen for insulin initiation. These include the "5S" situations - 'Severe' hyperglycaemia, 'Symptomatic' diabetes, 'Sick' diabetes (acute or chronic comorbidity), 'Special' situations (pregnancy, childhood, adolescence) and 'Secondary' diabetes (pancreatic, drug-induced, endocrine disorders). This review describes a practical approach to initiation and follow up of basal bolus insulin regimens.

Basal rate tests (24-hour fasts) performed in type-1 diabetic subjects with either absolute fasting or snacks containing negligible carbohydrate amounts result in similar glucose profiles: A randomized controlled prospective trial.

AIMS: Basal rate tests (24-hour fasting periods) may be necessary to optimize basal insulin replacement in type 1 diabetes. It was the aim of this study to prospectively compare the allowance of negligible carbohydrate snacks vs absolute fasting. METHODS: A total of 20 patients with type 1 diabetes (age, 48 ± 15 years (9 women, 11 men); BMI, 28.5 ± 4.5 kg/m2 ; HbA1c, 8.8% ± 2.0% (73.0 ± 21.9 mmol/mol); insulin dose, 0.69 ± 0.31 IU/kg body weight and per day) participated in 2 basal rate tests lasting 24 hours in random order with unchanged basal insulin replacement. On 1 occasion, negligible carbohydrate snacks (salads and vegetables, up to 5.1 g carbohydrate and 276.3 kJ per portion) were allowed; during the second test subjects were obliged to fast absolutely. Plasma glucose profiles were determined using an exact laboratory method. Hypoglycaemic episodes (plasma glucose < 70 mg/dL) were compared. RESULTS: Plasma glucose concentrations during fasting periods, with and without negligible carbohydrate snacks, did not differ significantly ( P = .65) and differences were negligible (95% confidence intervals always included a difference of 0 mmol/L). Also, there was no difference in the number of hypoglycaemic plasma glucose values (P = .40) or in compensatory carbohydrate intake. Basal rate testing with negligible carbohydrate snacks was better tolerated (questionnaire, P = .046) and the desire to discontinue the fasting period was significantly reduced (P = .023). CONCLUSIONS: Allowing negligible carbohydrate snacks results in unchanged plasma glucose profiles during basal rate testing and is better tolerated by patients with type 1 diabetes.

Inpatient management of type 2 Diabetes Mellitus: Does choice of insulin regimen really matter?

OBJECTIVE: To assess inpatient management of non-critically ill type 2 diabetics with different insulin regimen. METHODS: We reviewed the medical records of all non-critically ill type 2 diabetic patients more than 18 years of age in medical department of civil hospital Karachi and Dow University of Health Sciences from January 2011 to December 2012. We collected the data from case records in data collection sheets that fulfill the inclusion criteria and divided the study subjects into three groups according to insulin regimen they received. RESULTS: A total of 416 patients were analyzed out of which 220 were male. Subjects were divided into three groups according to insulin regimen they received. Majority were put on sliding scale of insulin (44.7%), while 33.1% and 22.1% subjects received basal bolus and pre-mixed insulin regimen respectively. Patients treated with basal bolus regimen had greater improvement in glycaemic control with short duration of hospital stay as compared to other two groups. The mean hyperglycaemic events were higher in sliding scale group while mean hypoglycaemic events were higher in basal bolus group. CONCLUSION: In non-critically ill type 2 diabetic patients the basal bolus regimen is superior to sliding and pre-mixed insulin regimen. Sliding scale should be discouraged in non-critically ill type 2 diabetic patients.

Titration of Basal and Prandial Insulin Doses With the Initiation of Glucagon-Like Peptide-1 Receptor Agonist Therapy.

Objective Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated significant efficacy in improving glycemic control in type 2 diabetes mellitus, which often results in decreased insulin dose requirements. The purpose of this study was to examine the changes in basal and prandial insulin dose requirements from baseline to three months following initiation of a GLP-1 RA. Methodology A retrospective chart review was conducted of adult insulin-treated patients at the Chertow Diabetes Center, Huntington, WV, who were started on GLP-1 RAs for 24 months. Results Mean daily basal insulin doses decreased by 8.7 units (P = 0.29; mean 8.3% change) and mean daily prandial insulin doses decreased by 9.4 units (P = 0.10; mean 18.4% change) from baseline to three months after starting a GLP-1 RA. Average hemoglobin A1c significantly decreased from 8.8% (73 mmol/mol) at baseline to 8.0% (64 mmol/mol) at three months (P < 0.001). Significant decreases from baseline to three months were also observed in mean body weight, mean low-density lipoprotein (LDL) cholesterol, and mean total cholesterol. Conclusions GLP-1 RA therapy was associated with a significant decrease in hemoglobin A1c, body weight, and LDL-cholesterol from baseline to three months after initiation. Therapy with GLP-1 RAs was also associated with an overall decrease in daily basal and prandial insulin dose requirements, although this finding did not reach statistical significance.

BEYOND 2 years: durability of metabolic benefits by simplification of complex insulin regimens in type 2 diabetes.

PURPOSE: To assess the magnitude and durability of the metabolic benefits by simplification of complex insulin treatments in patients with type 2 diabetes inadequately controlled by a full basal-bolus insulin regimen. Herein we report the results of the scheduled 2-year extension of the BEYOND trial. METHODS: Originally, 305 participants with inadequate glycemic control (HbA1c > 7.5%) were randomly assigned to intensification of basal-bolus insulin regimen (n = 101), to a fixed-ratio combination (basal insulin + GLP-1RA, n = 102), or to an association of basal insulin plus an SGLT-2 inhibitor (gliflo-combo, n = 102). The primary efficacy outcome was change from baseline in HbA1c at 24 months assessed by an intention-to-treat analysis. A per-protocol analysis was also performed. RESULTS: Fifty-five percent of patients completed the study in the two comparison arms. Compared with patients randomized to basal-bolus, patients of the other groups experienced non statistically different reductions in HbA1c level according to either an intention-to-treat analysis (-0.8 ± 1.1%, -0.7 ± 1.1%, and -1.3 ± 1.1%, mean ± SD, fixed-ratio, gliflo-combo and basal bolus, respectively) or per-protocol analysis (-1.2 ± 1.0%, -1.2 ± 1.1%, and -1.3 ± 1.0%, respectively). The final HbA1c level (per protocol) was 7.2 ± 0.8%, 7.3 ± 0.9%, and 7.5 ± 0.9%, respectively (P = NS). Treatment satisfaction (DTSQ) increased in both exchange groups, whereas the proportion of patients with hypoglycemia was lower. CONCLUSION: Simplification of complex insulin regimen may be a durable option in at least one-half of patients with type 2 diabetes. CLINICAL TRIAL REGISTRATION: Clinical trial registration no. NCT04196231, clinicaltrials.gov.

Efficacy and safety of once-weekly insulin icodec compared to once-daily insulin g U-100 in patients with type II diabetes: a systematic review and meta-analysis.

BACKGROUND//OBJECTIVE: Diabetes affects millions of people globally, despite treatment options, adherence and other factors pose obstacles. Once-weekly Insulin Icodec, a novel basal Insulin analog with a week-long half-life, offers potential benefits, enhancing convenience, adherence, and quality of life for improved glycemic control. This systematic review and meta-analysis aimed to assess the efficacy and safety of once-weekly Insulin Icodec compared to once-daily Insulin Glargine U-100 in individuals with type II diabetes (T2D). METHODS: A comprehensive literature search was conducted using PubMed, and Cochrane Library databases before September 2023 to identify relevant Randomized control trials (RCTs) with no language restrictions following PRISMA guidelines. The Cochrane risk-of-bias tool was used for quality assessment. All statistical analyses were conducted using RevMan (version 5.4; Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). RESULT: Four RCTs published from 2020 to 2023 with a cumulative sample size of 1035 were included. The pooled mean difference (MD) revealed a 4.68% longer TIR (%) with Insulin Icodec compared to Insulin Glargine U-100 [{95% CI (0.69, 8.68), p = 0.02}], the estimated mean changes in HbA1c (%) and FPG (mg%) were found to be insignificant between the two groups [MD = - 0.12 {95% CI (- 0.26, 0.01), p = 0.07}] and [MD = - 2.59 {95% CI (- 6.95, 1.78), p = 0.25}], respectively. The overall OR for hypoglycemia was also nonsignificant between the two regimens 1.04 [{95% CI (0.71, 1.52), p = 0.84}]. Other safety parameters were similar between the two groups. CONCLUSIONS: Switching from daily Insulin Glargine U-100 to weekly Insulin Icodec showed longer TIR (%) as well as similar blood glycemic control and safety profile. Hence, it may be a good alternate option for management of longstanding T2D.

Treatment of Type 2 Diabetes Mellitus in Advanced Chronic Kidney Disease for the Primary Care Physician.

Diabetes mellitus (DM) is a common cause of chronic kidney disease (CKD), leading to the need for renal replacement therapy (RRT). RRT includes hemodialysis (HD), peritoneal dialysis (PD), kidney transplantation (KT), and medical management. As CKD advances, the management of DM may change as medication clearance, effectiveness, and side effects can be altered due to decreasing renal clearance. Medications like metformin that were safe to use early in CKD may build up toxic levels of metabolites in advanced CKD. Other medications, like sodium-glucose co-transporter 2 inhibitors, which work by excreting glucose in the urine, may not be able to work effectively in advanced CKD due to fewer working nephrons. Insulin breakdown may take longer, and both formulation and dosing may need to be changed to avoid hypoglycemia. While DM control contributes to CKD progression, effective DM control continues to be important even after patients have been placed on RRT. Patients on RRT are frequently taken care of by a team of providers, including the primary care physician, both in and outside the hospital. Non-nephrologists who are involved with the care of a patient treated with RRT need to be adept at managing DM in this population. This paper aims to outline the management of type 2 DM in advanced CKD.

The IDEAL (Insulin therapy DE-intensificAtion with iglarLixi) Randomised Controlled Trial-Study Design and Protocol.

INTRODUCTION: Multiple daily injection insulin regimen (MDI) represents the most intensive insulin regimen used in the management of people with type 2 diabetes (PwT2D). Its efficacy regarding glycaemic control is counterbalanced by the increased risk of hypoglycaemia, frequently observed tendency to weight gain and necessity for frequent glucose monitoring. Recent introduction of novel antidiabetic medications with pleiotropic effects reaching far beyond the reduction of glycaemia (HbA1c), such as the glucagon-like peptide 1 receptor agonist (GLP-1 RA), has significantly widened the therapeutic options available for management of T2D. Consequently, there is currently a substantial number of PwT2D for whom the MDI regimen was initiated at a time when no other options were available. Yet, in present times, these individuals could benefit from simplified insulin regimens ideally taking advantage of the beneficial effects of the novel classes of antidiabetic medications. iGlarLixi (Suliqua®) is a once-daily fixed-ratio combination of basal insulin analogue glargine 100 U/ml and a GLP-1 RA lixisenatide. METHODS: Insulin therapy DE-intensificAtion with iglarLixi (IDEAL) is a six-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active treatment period examining the efficacy and safety of MDI regimen de-intensification with once-daily administration of iGlarLixi versus MDI regimen continuation in PwT2D on a backgroud therapy with metformin ± sodium-glucose cotransporter 2 inhibitor. PLANNED OUTCOMES: The primary objective is to compare the effects of MDI therapy de-intensification with iGlarLixi versus MDI regimen continuation regarding glycaemic control (HbA1c). Secondary objectives include detailed evaluation of the effects of MDI regimen de-intensification with iGlarLixi on glycaemic control using standardised continuous glucose monitoring (CGM) metrics and self-monitoring of plasma glucose. Furthermore, body weight and body composition analysis, quality of life and safety profile are evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT04945070.

Comparison of regular with NPH insulin vs. premix insulin in children and adolescents with type 1 diabetes in a resources-limited setting: a retrospective data analysis.

OBJECTIVES: Few studies addressed the efficacy of human insulin regimens (mostly premix insulin) used in many low-and-middle income countries on glycemic control of children and adolescents with diabetes. The aim of this study was to assess the efficacy of the premix insulin on the glycated hemoglobin (HbA1c) in comparison to the regular with NPH insulin scheme. METHODS: A retrospective study was carried out from January 2020 to September 2022 on patients with type 1 diabetes aged below 18 years followed in Burkina Life For A Child program. They were categorized into three groups, on regular with NPH insulin (Group A), on premix insulin (Group B) and on regular with premix insulin (Group C). Outcome was analyzed based on HbA1c level. RESULTS: Sixty-eight patients with a mean age of 15.38 ± 2.26 years and the sex ratio (M/W) 0.94 were studied. There were 14 in Group A, 20 in Group B, and 34 patients in Group C. The mean HbA1c value in the corresponding insulin regimen was 12.8 ± 1.39%, 9.87 ± 2.18%, and 10.66 ± 2.1%, respectively. Glycemic control was better in Groups B and C than Group A (p<0.05) but there was no difference between groups B and C. CONCLUSIONS: Our results indicate that the use of premix insulin gives a better glycemic control than NPH insulin. However, further prospective study of these insulin regimens with a strengthening education strategy and glycemic control by continuous glucose monitoring and HbA1c is required to corroborate these preliminary findings.

The Impact of Insulin Staging in the Context of Pharmaceutical Care on Patients with Type 2 Diabetes Mellitus.

Purpose: The problem of polypharmacy and the nature of the disease make patients with type 2 diabetes mellitus highly vulnerable to drug therapy problems, especially those who are on insulin therapy. Despite this challenge, reaching the desired clinical outcome and using an appropriate insulin regimen are also considered a controversial issue among clinicians. The current study is designed to explore the impact of insulin staging regimens in the context of pharmaceutical care on patients with type 2 diabetes mellitus. Patients and Methods: This study is a randomized interventional comparative study of a few groups. It was conducted at the Diabetes and Endocrine Centre in Sulaymaniyah City in Iraq from January to August 2022. Patients with T2DM who were on insulin therapy were enrolled in this trial. The participants were divided into two groups, the interventional and non-interventional groups. The insulin regimen was modified, and pharmaceutical care process was performed for the intervention group. Drug therapy problems (DTPs) and clinical parameters were monitored both groups over the course of six months. Results: A total of 67 patients with T2DM on insulin were included in this study, and of them, 73% were females, with a mean age of 57.34 ± 7.825 years. The groups were randomly divided into intervention and non-intervention groups. After six months of applying insulin staging in the context of pharmaceutical care, FPG (Mean Diff.= 72.25, 95% CI of diff.= 20.44 to 124.1), HbA1c (Mean Diff.= 2.087, 95% CI of diff.= 1.151 to 3.023) and DTP were significantly improved in the intervention group. Conclusion: Implementing the insulin staging approach within the context of the pharmaceutical care process showed a significant impact on controlling plasma glucose levels.

Perioperative Insulin Regimens in Patients With Insulin-Treated Type 2 Diabetes Mellitus Hospitalized for a Short Time for Minor Eye Surgery.

BACKGROUND: Elective surgery in patients with insulin-treated type 2 diabetes mellitus (T2D) and the admission period in the hospital, comprise a distinctive and challenging situation for physicians, nurses, as well as for the patients themselves. There is a lack of widely accepted evidence-based and standardized approach of care in regard to perioperative management of patients with insulin-treated T2D. METHODS: The main purpose of this proof-of-concept study was to investigate whether a standardized insulin and meal regimen on the day of surgery leads to a better management of diabetes in terms of blood glucose (BG) levels. Two different insulin and meal regimens-group A with half of insulin dose given with a standardized postoperative meal and group B with a custom preoperative breakfast and full insulin dose-were compared with Group C with routine care (no meal and no insulin injection on the day of surgery). Each group consisted of 12 to 15 patients. BG measurements were performed pre- and immediately postoperatively, before meals and at bedtime. RESULTS: Both standardized and well-defined insulin and meal regimens resulted in better average BG levels in the perioperative period, especially in the morning after the surgery. CONCLUSIONS: In this study, we observed that a standardized perioperative insulin regimen efficiently lowered postoperative BG levels. Providing a custom breakfast and a full insulin dose resulted in lower postoperative BG levels. These approaches were not associated with an increase in hypoglycemic events. Physicians and nursing staff gave positive feedback to the structured and well-defined approaches.

Dual-basal-insulin regimen for the management of dawn phenomenon in children with type 1 diabetes: a retrospective cohort study.

Background: Handling of the dawn phenomenon (DP) with multiple daily insulin injection (MDII) regimen is a real challenge. Objective: We aimed to demonstrate the effectiveness of a dual-basal-insulin (a long-acting glargine and an intermediate-acting neutral protamine Hagedorn (NPH)) regimen for the management of DP in children with type 1 diabetes mellitus (T1DM). The primary efficacy outcome was to overcome morning hyperglycemia without causing hypoglycemia during the non-DP period of the night. Design: Retrospective cohort study. Method: Charts of 28 children with T1DM (12 female; 42.8%, mean age 13.7 ± 2.1 years) treated with MDII were retrospectively reviewed. The median duration of diabetes was 4.5 years (range 2-13.5 years). DP was diagnosed using a threshold difference of 20 mg/dL (0.1 mmol/L) between fasting capillary blood glucose at 3 a.m. and prebreakfast. NPH was administered at midnight in addition to daily bedtime (08.00-09.00 p.m.) glargine (dual-basal-insulin regimen). Midnight, 03:00 a.m., prebreakfast and postprandial capillary blood glucose readings, insulin-carbohydrate ratios, and basal-bolus insulin doses were recorded the day before the dual-basal-insulin regimen was started and the day after the titration of the insulin doses was complete. Body mass index standard deviation scores (BMI SDS) at the onset-3rd-12th month of treatment were noted. Results: Before using dual basal insulin, prebreakfast capillary blood glucose levels were greater than those at midnight and at 03:00 a.m. (F = 64.985, p < 0.01). After titration of the dual-basal-insulin doses, there were significant improvements such that there were no statistically significant differences in the capillary blood glucose measurements at the three crucial time points (midnight, 03.00 a.m., and prebreakfast; F = 1.827, p = 0.172). No instances of hypoglycemia were reported, and the total daily insulin per kilogram of body weight did not change. The BMI SDS remained steady over the course of the 1-year follow-up. Conclusion: In this retrospective cohort study, the dual-basal-insulin regimen, using a long-acting glargine and an intermediate-acting NPH, was effective in overcoming early morning hyperglycemia due to insulin resistance in the DP. However, the effectiveness of the dual-basal-insulin regimen needs to be verified by prospective controlled studies using continuous glucose monitoring metrics or frequent blood glucose monitoring.

Association Between Real-Time Continuous Glucose Monitor Use and Diabetes-Related Medical Costs for Patients with Type 2 Diabetes.

Little is known about the impact of real-time continuous glucose monitoring (rtCGM) on diabetes-related medical costs within the type 2 diabetes (T2D) population. A retrospective analysis of administrative claims data from the Optum Research Database was conducted. Changes in diabetes-related health care resource utilization costs were expressed as per-patient-per-month (PPPM) costs. A total of 571 T2D patients (90% insulin treated) met study inclusion criteria. Average PPPM for diabetes-related medical costs decreased by -$424 (95% confidence interval [CI] -$816 to -$31, P = 0.035) after initiating rtCGM. These reductions were driven, in part, by reductions in diabetes-related inpatient medical costs: -$358 (95% CI -$706 to -$10, P = 0.044). Inpatient hospital admissions were reduced on average -0.006 PPPM (P = 0.057) and total hospital days were reduced an average of -0.042 PPPM (P = 0.139). These findings provide real-world evidence that rtCGM use was associated with diabetes-related health care resource utilization cost reductions in patients with T2D.

Anti-hyperglycemic Medication Compliance: A Quality Assurance Project.

In order to determine the prevalence of adherence among diabetes patients treated at Queens Hospital Center's Diabetes Clinic and to determine barriers preventing adherence, 50 patients were asked a series of questions regarding their medication intake. The majority of patients reported that they understood the self-management steps that were necessary in order to control their diabetes. However, 30% of the interviewed patients with type 1 or type 2 diabetes reported that they missed a dose of their diabetes medication on at least one day in the last month. Forgetting and lifestyle inconveniences were the two most frequently reported reasons for non-adherence. Side effects and problems with the pharmacy or insurance were also significant reasons for non-adherence. Adherence can potentially be increased by combining new forms of treatment and increasing educational reinforcement.

Insulin Management of Patients with Inadequately Controlled Type 2 Diabetes Admitted to Hospital: Titration Patterns and Frequency of Hypoglycemia as Results of a Prospective Observational Study (Hospital Study).

INTRODUCTION: Despite the continuously growing number of therapeutic options for type 2 diabetes mellitus (T2DM) including insulins, a large percentage of patients fail to achieve HbA1c targets. Several real-world studies focused on patients with T2DM receiving insulin treatment in outpatient settings were conducted, but information about real-world in-hospital insulin management is lacking. The aim of this study was to describe the management of insulin therapy with a focus on basal-bolus and premixed insulin regimens in patients with T2DM under routine in-hospital medical practice in the Czech Republic. METHODS: This non-interventional prospective study was conducted from June 2014 to December 2017 in 22 centers in the Czech Republic under routine clinical practice conditions. Adult patients admitted to hospital with metabolically uncontrolled T2DM [HbA1c ≥ 60 mmol/mol; > 7.6% Diabetes Control and Complications Trial (DCCT)] and there treated with basal-bolus and premixed insulin regimens were documented during hospitalization. RESULTS: Overall, 369 patients with T2DM (54.7% male, mean age 64.44 ± 13.84 years, BMI 31.10 ± 6.00 kg/m2, duration of diabetes 8.11 ± 9.93 years, HbA1c 95.90 ± 24.38 mmol/mol, length of stay was 7.94 ± 4.53 days) were included. The percentage of glucose values under 10 mmol/l at time of randomization (the group with basal-bolus insulin regimen vs. the premix insulin regimen group) was 24.2% vs. 33.5% (p = 0.053), at time of first insulin dose adjustment it was 43.1% vs. 50.0% (p = 0.330), and 1 day before hospital discharge it was 61.7% vs. 61.4% (p = 0.107). A hypoglycemic event occurred in a total of 15 patients in the basal-bolus regimen group, and no hypoglycemic event occurred in the premixed insulin regimen group. CONCLUSION: In-hospital insulin management regarding basal-bolus and premixed insulin regimens is safe and in concordance with current international recommendations.

Injectable combination therapies for the management of diabetes: an Indian perspective.

Introduction: This review focuses on currently available injectable combination therapies (ICTs) for managing diabetes.Areas covered: References were identified through searches of PubMed, Medline, and Embase for articles published till July 2019 using terms 'insulin' [MeSH Terms] OR 'glucagon like peptide 1 analogue' [All Fields] OR 'combination therapy' [All Fields] 'combination insulin therapy' [All Fields] OR 'combination GLP1 analogue therapy' [All Fields] OR 'premixed insulin' [All Fields].Expert opinion: Currently, there are nine types of ICTs for diabetes available. ICTs are classified on the basis of whether they are combinations of conventional human insulin, human insulin analogs, insulin coformulations, and insulin glucagon-like peptide-1 receptor agonists (GLP-1RA) and have a subtle difference in pharmacokinetic and pharmacodynamic properties. ICTs have been consistently demonstrated to play a major role in improving glycemic control. In a different meta-analysis involving patients assessed for glycemic control as the primary endpoint, no significant difference was noted with regard to HbA1c reduction, hypoglycemia, weight change, and daily insulin dose in patients on basal-bolus regimen, as compared to ICTs. All international guidelines recommend ICTs for treatment intensification.ICTs provide more flexibility to the treating doctor in fine-tuning the insulin/GLP-1RA regimen and have the advantages of reducing daily needle-prick count and better long-term compliance.

Regular insulin added to total parenteral nutrition vs subcutaneous glargine in non-critically ill diabetic inpatients, a multicenter randomized clinical trial: INSUPAR trial.

BACKGROUND: There is no established insulin regimen in T2DM patients receiving parenteral nutrition. AIMS: To compare the effectiveness (metabolic control) and safety of two insulin regimens in patients with diabetes receiving TPN. DESIGN: Prospective, open-label, multicenter, clinical trial on adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN. Patients were randomized on one of these two regimens: 100% of RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous GI. Data were analyzed according to intention-to-treat principle. RESULTS: 81 patients were on RI and 80 on GI. No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25). Mean capillary glucose was significantly lower in the GI group within two days after TPN interruption (160.3 ± 45.1 in RI vs 141.7 ± 43.8 mg/dL in GI; p = 0.024). The percentage of capillary glucose above 180 mg/dL was similar in both groups. The rate of capillary glucose ≤70 mg/dL, the number of hypoglycemic episodes per 100 days of TPN, and the percentage of patients with non-severe hypoglycemia were significantly higher on GI group. No severe hypoglycemia was detected. No differences were observed in length of stay, infectious complications, or hospital mortality. CONCLUSION: Effectiveness of both regimens was similar. GI group achieved better metabolic control after TPN interruption but non-severe hypoglycemia rate was higher in the GI group. CLINICAL TRIAL REGISTRY: This trial is registered at clinicaltrials.gov as NCT02706119.

Patient-Reported Outcomes with Insulin Glargine 300 U/mL in People with Type 2 Diabetes: The MAGE Multicenter Observational Study.

INTRODUCTION: MAGE was a Multicenter, single-Arm, observational 6-month (plus 6-month extension) study that aimed to assess treatment satisfaction, efficacy, and safety of insulin Glargine 300 U/mL (Gla-300) in people with type 2 diabetes (T2DM) receiving basal-bolus insulin in a rEal-world setting. MATERIALS AND METHODS: Participants were at least 18 years old, with T2DM for more than 1 year, HbA1c 7.0-10.0%. The primary endpoint was change in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) total score (baseline to month 6). Secondary endpoints included reasons for starting Gla-300, changes in the DTSQ change version (DTSQc) total score, Hypoglycemia Fear Survey-II (HFS-II) total behavior and worry scores at months 6 and 12, HbA1c changes at months 3, 6, 9, and 12, and safety. RESULTS: MAGE included 87 adults (mean T2DM duration 17 years). The primary endpoint of DTSQs mean (standard deviation) total score improvement at month 6 was achieved (2.80 [5.46] points; p < 0.0001). The main reasons for Gla-300 initiation were to decrease HbA1c (89.7% of participants) and reduce the number of hypoglycemic events (35.6% of participants). Significant improvements were observed in the DTSQc total score and perceived hyperglycemia/hypoglycemia (baseline to month 6, p < 0.05). Significant changes in HFS-II behavior, worry, and total scores at 6 and 12 months were also observed (p < 0.05). There were no statistically significant changes in HbA1c. Safety outcomes, including hypoglycemia, were comparable to previously reported trials. CONCLUSIONS: The MAGE study indicates that Gla-300, as part of a basal-bolus regimen, results in improved treatment satisfaction and reduced hypoglycemia fear in people with advanced T2DM.

Comparison of Human Premixed and Basal Plus Short-Acting Insulin Regimens for Individuals With Type 2 Diabetes During Ramadan Fasting.

Background Premixed insulin and basal insulin plus short-acting insulin regimens may be of value for treating individuals with type 2 diabetes (T2DM) who are fasting during Ramadan due to simplicity and better compliance. The objective of this study was to compare the effectiveness of human premixed insulin to basal plus short-acting insulin regimens in the management of fasting individuals with T2DM during Ramadan. Methods We conducted a prospective observational study in Basrah (southern Iraq) on 30 individuals with T2DM who fast during Ramadan. The enrolled patients were assigned into two groups at random: one group received a human premixed insulin regimen, the other received a basal plus short-acting insulin regimen. A baseline clinical and biochemical analysis was gathered for all patients at recruitment two weeks before fasting and within four weeks after the end of fasting. Patients were assessed twice during fasting month for insulin dose adjustment and documentation for any hyperglycemia or hypoglycemia. Results Fourteen patients were assigned to the premixed group, and 16 patients were assigned to the basal plus short-acting insulin group. The mean patient age was 53 ± 8 years, and the mean T2DM duration was 9.3 ± 4.2 years. The two groups were matched by age, body mass index, and glycated hemoglobin (HbA1c). There was no significant difference between the initial and final mean HbA1c in both groups. However, there was more non-significant HbA1c reduction in the premixed group as compared to the basal plus short-acting insulin group. The number of hypoglycemic events and weight changes among the two groups was not significant. Conclusions Both human premixed and basal plus short-acting insulin regimens are equally useful for glycemic control for patients with T2DM who choose to fast in observance of the month-long holiday of Ramadan.