Insulin isophane human 100units/ml suspension for injection 10ml vials

IntroductionInsulin is the first-line pharmacologic therapy for women with diabetes in pregnancy. However, conducting well-designed randomized clinical trials (RCTs) and achieving recommended glycemic targets remains a challenge for this unique population. This systematic literature review (SLR) aimed to understand the evidence for insulin use in pregnancy and the outcome metrics most often used to characterize its effect on glycemic, maternal and fetal outcomes in gestational diabetes mellitus (GDM) and in pregnant women with diabetes.MethodsAn SLR was conducted using electronic databases in Medline, EMBASE via Ovid platform, evidence-based medicine reviews (2010-2020) and conference proceedings (2018-2019). Studies were included if they assessed the effect of insulin treatment on glycemic, maternal or fetal outcomes in women with diabetes in pregnancy. Studies on any type of diabetes other than gestational or pre-existing diabetes as well as non-human studies were excluded.ResultsIn women diagnosed with GDM or pre-existing diabetes, most studies compared treatment of insulin with metformin (n = 35) followed by diet along with lifestyle intervention (n = 24) and glibenclamide (n = 12). Most studies reporting on glycemic outcomes compared insulin with metformin (n = 22) and glibenclamide (n = 4). Fasting blood glucose was the most reported clinical outcome of interest. Among the studies reporting maternal outcomes, method of delivery and delivery complications were most commonly reported. Large for gestational age, stillbirth and perinatal mortality were the most common fetal outcomes reported.ConclusionThis SLR included a total of 108 clinical trials and observational studies with diverse populations and treatment arms. Outcomes varied across the studies, and a lack of consistent outcome measures to manage diabetes in pregnant women was observed. This elucidates a need for global consensus on study design and standardized clinical, maternal and fetal outcomes metrics.

Abstract licence: CC BY-NC

IntroductionTo determine the impact of real-time continuous glucose monitoring (RT-CGM) in conjunction with 'Open loop'- continuous subcutaneous insulin infusion (CSII) as compared to conventional multiple daily injections (MDI) in type 1 diabetes.MethodsWe explored the COCHRANE database, MEDLINE, WEB OF SCIENCE, GOOGLE SCHOLARS, PUBMED, EMBASE, and cited literature in articles retrieved (2010-2021) for all randomized controlled trials and real-world trials of more than 6 months duration in patients with type 1 diabetes that compared RT-CGM+CSII vs RT- CGM+MDI. A total of 1645 publications have been identified; however, only 3 trials fulfilled our inclusion criteria with a total number of 150 patients (72 patients using RT-CGM+CSII and 78 patients on RT-CGM+MDI). A Systematic Review and Meta-analysis were carried out.ResultsNo statistically significant reduction in HbA1c was found on comparing RT-CGM+CSII vs RT- CGM + MDI, with p-value = .75. Likewise, impact on TIR, weight and insulin usage was found to be statistically insignificant with p-value of 0.15, 0.75 and 0.20 respectively. There was an overall homogeneity between the 3 trials in respect to all previous variables with I2 being 0%.ConclusionsReal-time continuous glucose monitors in conjunction with MDI open-loop CSII had a similar impact on HbA1c, weight, insulin usage and TIR. In addition, RT-CGM when combined with CSII was associated with higher costs and reduced quality of life, hence RT- CGM+MDI can be considered as a cheaper, safer yet equivalent substitute.Review registrationThis study was registered in PROSPERO (International prospective register of systematic reviews). Registration Name: RT-CGM in conjunction with CSII vs MDI in optimizing glycaemic control in T1DM: a systematic review.Registration noCRD42021255333. Accessible at: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021255333. Amendments: Few amendments to the above-mentioned registration were made: (1) Title (Meta-analysis was added). (2) Prof. Gleeson was added as an author. (3) Real-world trials were included. (4) Outcomes required in studies as per our inclusion criteria amended to include at least 1 outcome. (5) Bias risk was assessed by the CASP tool.

Abstract licence: CC BY

A frequent complication in kidney transplantation is post-transplant diabetes mellitus (PTDM). The primary goal of this study is to review the risk factors and preventive methods and compare the different available anti-diabetic medications for the management of PTDM. We searched databases like Pubmed and Google Scholar for related articles using specific terms and phrases. Following a thorough investigation, we applied the inclusion and exclusion criteria and completed a quality assessment. Modifiable risk factors have a significant role in the development of PTDM. The combinations of immunosuppressive treatment tacrolimus (TAC), cyclosporine A (CYC), and everolimus (EVL), steroids increase the incidence of PTDM significantly. Insulin is the most effective treatment for PTDM in the early transplant period; however, oral anti-diabetic medications look promising. Further clinical trials are required to determine the optimum treatment method for reducing the occurrence of PTDM and treating the existing condition with novel anti-hyperglycemic medications.

Abstract licence: CC BY

IntroductionLong-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where glycaemic control is typically poor and food insecurity is common, long-acting insulin analogues may offer tangible clinical benefits for people with T1D. To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.Methods and analysisThis is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). Blinded continuous glucose monitors will be used to assess glycaemic control in both study arms over 14-day periods at baseline and at 3, 6 and 12 months after randomisation. The co-primary outcomes are the per cent time in serious hypoglycaemia (Ethics and disseminationThis study was approved by the Institutional Review Board at the University of Pittsburgh (STUDY21110122), the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4265) and the Ethical Review Committee (ERC) of Diabetic Association of Bangladesh (BADAS-ERC/EC/22/405). Research findings will be shared by the local partner organisations and institutions with relevant stakeholders including youth living with diabetes, policy makers, healthcare workers and the general public. Findings will also be shared at local, regional and international scientific meetings.Trial registration numberClinicalTrials.gov: NCT05614089.

Abstract licence: CC BY-NC