Partial Clinical Remission of Type 1 Diabetes in Swedish Children: A Longitudinal Study from the Swedish National Quality Register (SWEDIABKIDS) and the Better Diabetes Diagnosis (BDD) Study.

Aims/Hypotheses: To investigate the frequency and characteristics of partial remission in Swedish children with type 1 diabetes and whether the insulin delivery method, that is, continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDIs), affects incidence and duration of this period, 2007-2011. Factors that increase the proportion of subjects who enter partial remission and extend this period can improve long-term metabolic control and reduce the risk of severe hypoglycemia, improve quality of life, and, in the long run, reduce late complications. Methods: Longitudinal data from 2007 to 2020 were extracted from the Swedish National Quality Register (SWEDIABKIDS) with all reported newly diagnosed children. Data on C-peptide from the participants in the Better Diabetes Diagnosis study from 2007 to 2010 were used. The definition of partial remission was insulin dose-adjusted HbA1c: HbA1c (%) + [4 × total daily insulin dose (U/kg/day)] ≤9. Results: Of the 3887 patients, 56% were boys. More boys than girls were in partial remission throughout the follow-up period until 24 months after diabetes onset. Fewer children 0-6 years old had partial remission at 3 and 12 months but not at 24 months compared with older age-groups. A larger proportion of patients using CSII at 12 and 24 months remained in partial remission compared with those with MDI (37% vs. 33%, P = 0.02 and 31% vs. 27%, P = 0.01, respectively). The level of C-peptide was higher in the group with partial remission and mean HbA1c was lower (both P < 0.001). Partial remission at 12 months after diabetes onset was associated with CSII (odds ratio [OR]: 1.39, confidence interval [CI]:1.13, 1.71), shorter diabetes duration (OR: 0.80, CI: 0.76, 0.84), and male sex (OR: 1.23, CI: 1.04, 1.46). Conclusions/Interpretation: Insulin through MDI, longer duration of diabetes, and female sex were associated with lower frequency of partial remission. Use of CSII seems to contribute to longer partial remission among Swedish children with type 1 diabetes.

Continuous subcutaneous insulin infusion versus multiple daily injection therapy in pregnant women with type 1 diabetes.

INTRODUCTION: The study aimed to compare glycemic control and pregnancy outcomes in women with type 1 diabetes mellitus (T1DM) using multiple daily injection therapy (MDI) and continuous subcutaneous insulin infusion (CSII) and to compare outcomes of women treated with long-acting insulin or neutral protamine Hagedorn (NPH). METHODS: This multicenter prospective cohort study involved women with pregestational T1DM treated with MDI and CSII. Primary outcome was glycated hemoglobin (HbA1c) before and during pregnancy. Secondary outcomes included maternal and neonatal outcomes and quality of life. RESULTS: Of the 121 studied women, the average age was 28.48 years, and the average body mass index was 21.29 kg/m2 at conception and 26.32 kg/m2 at delivery. Of the studied women, 78.51% had planned pregnancy. Women treated with MDI and CSII had comparable HbA1c before pregnancy or in the first and second trimesters. In the third trimester, women on CSII therapy had significantly lower HbA1c (6.07 ± 0.62 vs 6.20 ± 0.88%, p = .017), higher HbA1c on-target rate (71.43% vs 64.62%, p = .030), and greater decline of HbA1c from preconception to the third trimester (-0.65 vs -0.30%, p = .047). Fewer daily insulin requirements were observed in those used CSII compared with MDI-treated women (0.60 ± 0.22 vs 0.73 ± 0.25 U/kg/day, p = .004). Newborns born of mothers treated with the CSII method were more likely to have neonatal jaundice (adjusted odds ratio [OR] 2.76, 95% confidence interval [CI] 1.16-6.57) and neonatal intensive care unit (adjusted OR 3.73, 95%CI 1.24-11.16), and women on CSII had lower scores in patient-reported quality of life (p = .045). In the MDI group, those receiving long-acting insulin had nonsignificant lower HbA1c and higher HbA1c on-target rate in the second and third trimesters, compared with those treated with NPH. CONCLUSIONS: Insulin pump users may achieve better glycemic control than multiple daily insulin injections, which did not substantially improve pregnancy outcome.

Recovery of hypoglycemic confidence using intermittently scanned continuous glucose monitoring among adults with type 1 diabetes with level 3 hypoglycemia: A prospective, single-center, single-arm study.

AIM: To investigate whether the FreeStyle Libre, an intermittent scanning continuous glucose monitoring (isCGM) system, influences confidence in managing hypoglycemia in adults with type 1 diabetes. MATERIALS AND METHODS: This longitudinal, observational study conducted at one facility included 121 adults with type 1 diabetes. Participants used the conventional finger-prick method for self-testing glucose before using isCGM. At baseline and 12 months after initiating isCGM, the Hypoglycemic Confidence Scale (HCS), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and HbA1c were performed. At 12 months, the percentage of individuals utilizing isCGM trend arrows for glucose management was observed. The primary endpoint was hypoglycemic confidence change attributed to using isCGM. RESULTS: After using isCGM, HCS scores improved significantly from 2.89 (2.56, 3.22) to 3.00 (2.20, 3.33) (p < 0.001); median (25%, 75%). Among participants with level 3 hypoglycemia at baseline, hypoglycemic confidence during sleep (p < 0.05), in social situations (p < 0.05), and in avoiding serious hypoglycemia-related problems (p < 0.05) were improved. Despite hypoglycemia risk, participants could continue daily activities by using isCGM (p < 0.05), and sixty-nine percent utilized trend arrows effectively. CONCLUSION: Using isCGM improved hypoglycemic confidence among adults with type 1 diabetes. Data analysis indicated that people with type 1 diabetes could live more freely and better manage hypoglycemia using isCGM.

Improving Clinician Confidence in Insulin Prescriptions at Discharge for Individuals With Newly Diagnosed Type 1 Diabetes.

Background In a questionnaire, we found that pediatric clinicians at Basildon and Thurrock University Hospital (BTUH) have low confidence levels in prescribing multiple daily injections (MDI) for newly diagnosed pediatric patients with type 1 diabetes mellitus. We designed and evaluated locally tailored prescription guidance to improve confidence in MDI discharge prescriptions for pediatric doctors of all grades. Methods We designed a prescription guidance tool by adapting existing local guidelines to improve clinician familiarity with MDI prescriptions and prevent prescription errors. The intervention was delivered in a single pediatric unit to doctors of all levels. Feedback was collected, and the clinicians' confidence in their MDI prescriptions was evaluated before and after the intervention. Questionnaires were distributed to all pediatric doctors within the unit to assess their confidence in prescribing MDIs using a five-point Likert Scale. Furthermore, the questionnaires aimed to determine whether clinicians regularly consulted the existing local guidelines. Local guidelines were adapted in consultation with the local pediatric diabetic multidisciplinary team (MDT) and with reference to the East of England Pediatric Diabetes Network to present MDI guidance in a more concise format, which includes an example MDI discharge medication checklist. Following approval by the local guidelines management group, additional changes were made to enhance the practicality and accessibility of the discharge prescription guidance for clinicians. These guidelines were distributed to the pediatric MDT via email and displayed in visible areas of the department. Results Out of the 13 doctors surveyed, 10 provided pre- and post-intervention feedback (77%). Statistical significance was calculated using unpaired t-tests. Ninety percent of pediatric doctors routinely refer to local guidelines for guidance on MDI prescriptions. However, 50% of respondents felt that existing local guidelines were not easily accessible, given the time and effort required to locate them. The mean confidence score for completing MDI prescriptions at discharge before the intervention was 1.9 (SD: 0.83). After the intervention, it increased to 4 (SD: 0.63) (95% CI: 2.79-1.41, p<0.0001). Ninety percent of pediatric doctors felt that the design and display of the MDI guidelines optimized patient care. Conclusions Following the presentation of the project at a local audit and quality improvement (QI) meeting, the adapted guidelines were included in the junior doctor induction program at BTUH and made accessible on the local intranet. The production of locally tailored prescription guidance for MDI prescriptions at discharge has led to an increase in the confidence of pediatric doctors when writing their prescriptions. We aimed to continue updating this guidance as necessary and making further developments to enhance clinician confidence.

Intermittent closed-loop blood glucose control for people with type 1 diabetes on multiple daily injections.

BACKGROUND AND OBJECTIVES: Recent advances in Automated Insulin Delivery systems have been shown to dramatically improve glycaemic control and reduce the risk of hypoglycemia in people with type 1 diabetes. However, they are complex systems that require specific training and are not affordable for most. Attempts to reduce the gap with closed-loop therapies using advanced dosing advisors have so far failed, mainly because they require too much human intervention. With the advent of smart insulin pens, one of the main constraints (having reliable bolus and meal information) disappears and new strategies can be employed. This is our starting hypothesis, which we have validated in a very demanding simulator. In this paper, we propose an intermittent closed-loop control system specifically intended for multiple daily injection therapy to bring the benefits of artificial pancreas to the application of multiple daily injections. METHODS: The proposed control algorithm is based on model predictive control and integrates two patient-driven control actions. Correction insulin boluses are automatically computed and recommended to the patient to minimize the duration of hyperglycemia. Rescue carbohydrates are also triggered to avoid hypoglycemia episodes. The algorithm can adapt to different patient lifestyles with customizable triggering conditions, closing the gap between practicality and performance. The proposed algorithm is compared with conventional open-loop therapy, and its superiority is demonstrated through extensive in silico evaluations using realistic cohorts and scenarios. The evaluations were conducted in a cohort of 47 virtual patients. We also provide detailed explanations of the implementation, imposed constraints, triggering conditions, cost functions, and penalties for the algorithm. RESULTS: The in-silico outcomes combining the proposed closed-loop strategy with slow-acting insulin analog injections at 09:00 h resulted in percentages of time in range (TIR) (70-180 mg/dL) of 69.5%, 70.6%, and 70.4% for glargine-100, glargine-300, and degludec-100, respectively, and injections at 20:00 h resulted in percentages of TIR of 70.5%, 70.3%, and 71.6%, respectively. In all the cases, the percentages of TIR were considerably higher than those obtained from the open-loop strategy, being only 50.7%, 53.9%, and 52.2% for daytime injection and 55.5%, 54.1%, and 56.9% for nighttime injection. Overall, the occurrence of hypoglycemia and hyperglycemia was notably reduced using our approach. CONCLUSIONS: Event-triggering model predictive control in the proposed algorithm is feasible and may meet clinical targets for people with type 1 diabetes.

A Systematic Review and Meta-Analysis of Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Type-2 Diabetes.

Diabetes mellitus (DM) has a growing prevalence worldwide, even in developing countries. Many antidiabetic agents are used to improve glycemic control; however, in cases of an insufficient outcome, insulin is administered. Yet, the timing of proper insulin administration is still a subject of intense research. To date, there have been no recommendations or guidelines for the use of continuous subcutaneous insulin infusion (CSII) in Type 2 Diabetes Mellitus (T2DM). In the present study, we have performed a meta-analysis to evaluate the use of CSII in patients with T2DM. An extensive literature search was conducted through the electronic databases Pubmed, Clinicaltrials.gov, and Cochrane Central Register of Controlled Trials (CENTRAL) from October 2019-May 2022, for interventional studies related to T2DMI and CSII versus multiple daily injections (MDI). We included articles published in the English language only, yielding a total of thirteen studies. We found better outcomes in patients receiving CSII, in regard to glycated hemoglobin (HbA1c) and total insulin dose. In contrast, fasting plasma glucose and body weight did not show statistically significant differences between the two groups. Our analyses showed that CSII could be beneficial in patients with T2DM in order to achieve their glucose targets.

Outcomes in Pump- and CGM-Baseline Use Subgroups in the International Diabetes Closed-Loop Trial.

BACKGROUND: We investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump. MATERIALS AND METHODS: In a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices. The participants were stratified into four subgroups: insulin pump and CGM (pump+CGM), pump-only, MDI and CGM (MDI+CGM), and MDI users without CGM (MDI-only) users. We compared glycemic outcomes among four subgroups. RESULTS: At baseline, 61% were pump+CGM users, 18% pump-only users, 10% MDI+CGM users, and 11% MDI-only users. Mean time in range 70-180 mg/dL (TIR) improved from baseline in the four subgroups using CLC: pump+CGM, 62% to 73%; pump-only, 61% to 70%; MDI+CGM, 54% to 68%; and MDI-only, 61% to 69%. The reduction in time below 70 mg/dL from baseline was comparable among the four subgroups. No interaction effect was detected with baseline device use for TIR (P = .67) or time below (P = .77). On the System Usability Questionnaire, scores were high at 26 weeks for all subgroups: pump+CGM: 87.2 ± 12.1, pump-only: 89.4 ± 8.2, MDI+CGM 87.2 ± 9.3, MDI: 78.1 ± 15. CONCLUSIONS: There was a consistent benefit in patients with T1D when using CLC, regardless of baseline insulin delivery modality or CGM use. These data suggest that this CLC system can be considered across a wide range of patients.

Use of continuous subcutaneous insulin infusion versus multiple daily injections in emerging adults with type 1 diabetes is associated with better clinical engagement but not glycaemic control.

BACKGROUND: Limited studies have compared outcomes between emerging adults with type 1 diabetes mellitus (T1D) attending a diabetes transition support programme using multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). AIMS: To assess glycaemic control and service utilisation in emerging adults with T1D on MDI or CSII attending a young adult diabetes clinic (YAC). METHODS: A retrospective cohort analysis was conducted from January 2013 to December 2015. Data collected included clinic visits per year, after-hours mobile telephone use, diabetic ketoacidosis (DKA) admissions and all HbA1c levels. Independent t-test was used to compare continuous variables whilst Pearson's Chi-squared test was used for categorical variables. Linear mixed effects models explored mean changes in HbA1c levels over time. RESULTS: Over 3 years, 318 youth with T1D (176 MDI, 121 CSII, 21 switched from MDI to CSII) attended our YAC. Aggregated mean HbA1c levels remained similar between modalities (CSII 9.1% vs MDI 9.3%; P = 0.23); however, mean change in HbA1c at 3 years was significantly increased in CSII users at 0.55% (95% CI 0.15-0.95; P < 0.01) compared with no significant change in MDI users. Clinic visits per year were improved in CSII users (CSII 2.8 vs MDI 2.5; P = 0.02), while DKA admissions remained similar between MDI and CSII users (3.6 admissions per 100 patient-years). CONCLUSION: In our YAC cohort, glycaemic control in CSII and MDI users was similar but well below recommended international glycaemic targets (HbA1c level < 7.0%). Despite increased clinical engagement occurring in CSII users, glycaemic deterioration was observed over the 3 years.

Diurnal Variation of Real-Life Insulin Sensitivity Factor Among Children and Adolescents With Type 1 Diabetes Using Ultra-Long-Acting Basal Insulin Analogs.

Background: Estimation of insulin sensitivity factor (ISF) is essential for correction insulin doses calculation. This study aimed to assess real-life ISF among children and adolescents with type 1 diabetes using ultra-long-acting basal insulin analogs and to detect factors associated with ISF among those patients. Methods: This prospective observational study was conducted at Sohag University Hospital, Egypt, and included 93 participants aged 6-18 years, diagnosed with T1DM for at least 1 year and using insulin glargine 300 Units/mL or insulin degludec 100 Units/mL as basal insulin. The ISF, insulin-to-carbohydrate ratio (ICR) and insulin doses were initially assessed then adjusted as required. The participants were regularly contacted throughout the follow-up period. Glycemic control parameters were assessed after 3 months. Results: The ISF showed diurnal variation with higher correction dose requirements for the morning than for the rest of the day (p < 0.001). This pattern of diurnal variation was found in participants with different pubertal stages and in participants using either type of ultra-long acting basal insulin analogs. There was no significant difference between the ISF calculated according to the 1800 rule [1800/Total daily insulin dose (TDD)] and the morning ISF (p = 0.25). The 1800 rule-calculated ISF was significantly lower than the actual ISF for the afternoon (p < 0.001) and the evening (p < 0.001). ISF at different times of the day were significantly correlated with age, body mass index, pubertal stage, diabetes duration, TDD, and ICR. Multiple regression analysis revealed that ICR was the most significant factor associated with ISF. Linear regression analysis revealed that the ISF (in mg/dL) for any time of the day could be estimated as 5.14 × ICR for the same time of the day (coefficient = 5.14, 95% confidence interval: 5.10-5.19, R 2 = 0.95, p < 0.001). Conclusion: Diurnal variation of ISF that had to be considered for proper calculation of correction doses. This diurnal variation was found in children and adolescents with different pubertal stages. The 1800 rule was appropriate for the morning correction doses but not in the afternoon or the evening. The TDD and the ICR could be used for ISF estimation.

Comparing continuous subcutaneous insulin infusion and multiple daily injections in children with Type 1 diabetes in Sweden from 2011 to 2016-A longitudinal study from the Swedish National Quality Register (SWEDIABKIDS).

OBJECTIVE: This study aimed to compare metabolic control measured as hemoglobin A1c (HbA1c), the risk of severe hypoglycemia, and body composition measured as body mass index standard deviation scores (BMI-SDS) in a nationwide sample of children and adolescents with Type 1 diabetes with continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI), respectively. RESEARCH DESIGN AND METHODS: Longitudinal data from 2011 to 2016 were extracted from the Swedish National Quality Register (SWEDIABKIDS) with both cross-sectional (6 years) and longitudinal (4 years) comparisons. Main end points were changes in HbA1c, BMI-SDS, and incidence of severe hypoglycemia. RESULTS: Data were available from 35,624 patient-years (54% boys). In general, HbA1c decreased approximately 0.5% (2-5 mmol/mol) from 2011 to 2016 (ptrend < 0.001) and the use of CSII increased in both sexes and all age groups. Mean HbA1c was 0.1% (0.7-1.5 mmol/mol) lower in the CSII treated group. Teenagers, especially girls, using CSII tended to have higher BMI-SDS. There was no difference in the number of hypoglycemias between CSII and MDI over the years 2011-2016. CONCLUSIONS: There was a small decrease in HbA1c with CSII treatment but of little clinical relevance. Overall, mean HbA1c decreased in both sexes and all age groups without increasing the episodes of severe hypoglycemia, indicating that other factors than insulin method contributed to a better metabolic control.

Effectiveness and equity of continuous subcutaneous insulin infusions in pediatric type 1 diabetes: A systematic review and meta-analysis of the literature.

AIMS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCT) and non-randomized studies (NRS) to assess the effectiveness and equity of continuous subcutaneous insulin infusions (CSII) versus multiple-daily injections (MDI) on glycemic outcomes. METHODS: Searches were conducted between 2000 and 2019 in MEDLINE, CENTRAL, EMBASE and HTA. Included studies compared the CSII vs MDI in children and young people (CYP) ≤ 20 years with type 1 diabetes. Two independent reviewers screened the articles, extracted the data, assessed the risk of bias, evaluated the quality of evidence, and identified equity data. Results were pooled with a random-effects model. RESULTS: Of the 578 articles screened, 16 RCT (545 CYP on CSII) and 70 NRS (73253 on CSII) were included in the meta-analysis. There was moderate-level evidence that the CSII lower HbA1c in RCT (pooled mean difference [MD]: -0.22%; 95% confidence interval [CI]: -0.33, -0.11%; I2:34%) and insufficient in NRS (pooled MD: -0.45%; 95%CI: -0.52, -0.38%; I2:99%). The pooled incidence rate ratio of severe hypoglycemia on CSII vs MDI in RCT was 0.87 (95%CI: 0.55, 1.37; I2:0%; low-level evidence), and 0.71 (95%CI: 0.63, 0.81; I2:57%, insufficient evidence) in NRS. Health-related quality of life presented insufficient evidence. Equity data were scarcely reported. CONCLUSIONS: CSII modestly lower HbA1c when compared with MDI. Current literature does not provide adequate data on other glycemic outcomes. Future assessment on diabetes technology should include individual and area-level socioeconomic data. The study protocol was pre-registered in PROSPERO (CRD42018116474).

10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes.

AIM: The aim of this study was to evaluate the 10-day initiation protocol for MiniMed 670G hybrid closed-loop (HCL) system in individuals with type 1 diabetes on multiple daily injection (MDI) in achieving desirable glycemic control. METHODS: An open-label single-arm, single-center, clinical investigation in children aged 7-18 years on MDI following a structured protocol: 2 days, HCL system assessment; 5 days, HCL system training (2-h sessions on 5 consecutive days with groups of 3-5 participants and families); 3 days, Manual Mode use of HCL system; 84 days, Auto Mode use of the HCL system, cumulating in 10 days from MDI to Auto Mode activation. RESULTS: A total of 30 children (age 10.24 ± 2.6 years) were enrolled in the study, and all completed the planned 84 days on Auto Mode. The participants used the sensor for a median of 92% of the time and spent a median of 89% in Auto Mode. The mean HbA1c decreased from 8.2 ± 1.4% (66 ± 15.3 mmol/mol) at baseline to 6.7 ± 0.5% (50 ± 5.5 mmol/mol) at the end of the study (p = 0.017). Time in range (70-180 mg/dL) increased from 46.9 ± 18.5% at baseline to 75.6 ± 6.9% in Auto Mode (p < 0.001). This was achieved while spending 2.8% of the time below 70 mg/dL and without any severe hypoglycemia or DKA. CONCLUSION: Children and adolescents with type 1 diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol.

Insulin pumps use in Greece: Efficacy and safety data from 140 patients with type 1 diabetes mellitus.

OBJECTIVE: The aim of this study was to investigate the efficacy and safety of continuous subcutaneous insulin infusion (CSII) regarding glycaemic control and quality of life in patients with type 1 diabetes mellitus (T1DM), who were previously treated with multiple daily injections (MDI). PATIENTS AND METHODS: 140 patients with T1DM [mean age 33.7 ± 22.1 years; 54 males, 76 females, 10 children; duration of diabetes 19.1 ± 8.4 years; total daily insulin usage while on MDI (IU/day) 57.86 ± 15.32; HbA1c at the beginning of CSII treatment 8.67 ± 1.54%] were included in the study. HbA1c, glucose levels, BMI, severe hypoglycemic and diabetic ketoacidosis (DKA) episodes were recorded and compared to the data prior to CSII introduction. The evaluation of the quality of life was assessed with a self-questionnaire adjusted from the SF-12 and diabetes quality of life (DQoL) questionnaires. RESULTS: HbA1c was reduced from 8.67 ± 1.54 to 6.85 ± 0.52% (p < 0.001). This reduction was independent of age, gender, body mass index (BMI) and diabetes duration. Daily insulin requirements were lower at the end of the follow-up (36.40 ± 12.20 IU/day) compared with the needs during enrolment (57.86 ± 15.32 IU/day) (p < 0.001). BMI presented no significant alterations. Ten (10) severe hypoglycemic episodes were recorded but the overall rate was decreased by 71.5% (p < 0.001). Only 3 cases of ketoacidosis were recorded. Quality of life parameters were remarkably improved. CONCLUSIONS: This study provided evidence that CSII treatment was superior to MDI for patients with T1DM in Greece. CSII offered a safe, effective alternative to MDI, while improving glycaemic control, side-effects and quality of life.

Glyco-metabolic control, inflammation markers, and cardiovascular outcomes in type 1 and type 2 diabetic patients on insulin pump or multiple daily injection (italico study).

BACKGROUND: To evaluate if the positive effects recorded on glycaemic control with continuous subcutaneous insulin infusion (CSII) were maintained on the long-term compared with multiple daily injection (MDI). The secondary objective was to evaluate if there is a reduction of type and number of cardiovascular events (CV). METHODS: This retrospective, observational study evaluated glycaemic control and the number of CV in 104 patients with type 1 or 2 diabetes previously treated with MDI and initiating CSII therapy with tubed insulin pumps compared with 109 patients previously treated with MDI continuing MDI. RESULTS: After 8 years, the glycaemic control including glycated haemoglobin (HbA1c ), fasting plasma glucose (FPG), and prandial plasma glucose (PPG) improved with both CSII and MDI compared with baseline; however, HbA1c , FPG, and PPG recorded with CSII were lower than data recorded with MDI. During the 8 years, there were fewer CV events with CSII, compared with MDI, and in particular, there were fewer cases of atrial fibrillation, premature ventricular contractions, acute coronary infarction, angina pectoris, heart failure, and peripheral vascular ischemia. We did not record any reduction of ischemic stroke events. CONCLUSION: Our preliminary data suggest that CSII treatment seems to reduce the rates of CV compared with MDI therapy. Moreover, CSII also improved glycaemic control, without increasing the number of hypoglycaemia. However, given the observational design of this trial, our data should be validated in a randomized clinical trial; if they will be confirmed, CSII could be chosen for fully informed and motivated patients at higher risk of developing CV.

Pregnancy outcomes among women with type 1 diabetes mellitus using continuous subcutaneous insulin infusion versus multiple daily injections: A retrospective cohort study.

BACKGROUND: Insulin delivery options for pregnant women with type 1 diabetes mellitus are either continuous subcutaneous insulin infusion or multiple daily injections. The aim of this paper is to compare pregnancy outcomes in women with type 1 diabetes mellitus using continuous subcutaneous insulin infusion or multiple daily injections in pregnancy. METHODS: Retrospective single-centre cohort study of 298 pregnancies booked between 2006 and 2016. Descriptive analysis was performed for HbA1c values. Logistic regression models were created to compare selected maternal and neonatal outcomes. RESULTS: Continuous subcutaneous insulin infusion was associated with increased risk of large-for-gestational age (aOR 2.00, 95% CI 1.20-3.34) and preterm neonates (aOR 1.80, 95% CI 1.04-3.03). Continuous subcutaneous insulin infusion had no association with increased risk of adverse pregnancy outcomes. No difference in HbA1c values existed between groups. CONCLUSION: Using continuous subcutaneous insulin infusion for type 1 diabetes mellitus through pregnancy is associated with increased risk of large-for-gestational age and preterm neonates, without increased risk of associated adverse maternal or neonatal outcomes.

Prospective evaluation of insulin-to-carbohydrate ratio in children and adolescents with type 1 diabetes using multiple daily injection therapy.

AIM: Assessment of insulin-to-carbohydrate ratio (ICR) in children and adolescents with type 1 diabetes mellitus (T1DM) using multiple daily injection (MDI) therapy. METHODS: This prospective observational study was conducted over a 2-year period at Sohag University Hospital, Egypt. Children and adolescents aged 4 to 17 years, diagnosed with T1DM for at least 1 year, with fasting serum C-peptide levels <0.24 ng/dL and whose parents accepted to shift their management to flexible MDI using carbohydrate counting, were included. Participants were initially hospitalized for estimation of ICR and insulin doses, then followed-up monthly for further adjustments. Insulin doses, ICR, and glycemic control parameters were assessed after 3 months. RESULTS: The study included 201 participants, 110 (54.7%) of them were males. The median age was 9.5 years (interquartile range: 7-12.5 years). Bolus insulin requirements estimated by the 500 rule were significantly lower than the actual doses used by the study participants for all meals (P < .001). Bolus insulin requirement for morning meal was significantly higher compared to other meals (P < .001). Linear regression analyses between ICR for different meals and the reciprocal of total daily dose (TDD) in 96 participants with optimum glycemic control revealed that ICR could be calculated as 301 to 309/TDD for morning meal (R2 = 0.97, P < .001), 317 to 331/TDD for afternoon meal (R2 = 0.96, P < .001), and 362 to 376/TDD for evening meal (R2 = 0.98, P < .001). CONCLUSIONS: Bolus insulin requirements showed diurnal variation. Using 301 to 309/TDD, 317 to 331/TDD, and 362 to 376/TDD formulas would be more appropriate than the 500 rule for initial estimation of ICR for morning, afternoon, and evening meals, respectively.

Continuous subcutaneous insulin infusion versus multiple daily injections for type 1 diabetes.

To review the literature on continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) to help the family of a 13-year-old girl with type 1 diabetes mellitus on MDI choose the best insulin delivery method for her to improve her glycaemic control. A literature search was performed to assess available evidence regarding CSII use versus MDI use for glycaemic control. We identified 15 relevant articles and present these, with a detailed analysis of a multicentre randomised controlled trial by Mueller-Godeffroy et al. Although CSII use demonstrated a reduction in HbA1c (-0.18 to -0.7%) in some studies compared to MDI, this finding was not consistent across all studies. Mueller-Godeffroy et al. did not find a statistically significant different in HbA1c between CSII and MDI patients; however, additional benefits of insulin pump therapy, including improved diabetes-related quality of life and reduced care giver burden, were reported. Further high-quality randomised controlled trials and long-term data are required to assess the benefits of CSII over MDI and the longevity of these methods.

Comparison of the efficacy and safety of insulin degludec/aspart (twice-daily injections), insulin glargine 300 U/mL, and insulin glulisine (basal-bolus therapy).

AIMS/INTRODUCTION: We compared the efficacy and safety of insulin degludec/aspart (IDegAsp) twice-daily injections with insulin glargine 300 U/mL and insulin glulisine basal-bolus therapy (Gla300/Glu) using insulin glargine 300 U/mL (Gla300) and insulin glulisine (Glu). MATERIALS AND METHODS: A total of 20 patients with type 2 diabetes mellitus were treated with IDegAsp twice-daily injections; achievement of target preprandial glucose concentration of 100-130 mg/dL at breakfast and supper was determined using a wearable flash glucose monitoring system. Patients were later switched to Gla300/Glu basal-bolus therapy before breakfast and before supper. Data were collected on days 2-4 and days 12-14 for each treatment period. The study's primary efficacy end-point was the mean percentage of time with a target glucose range of 70-180 mg/dL, and safety end-points were the mean percentage of time with hypoglycemia having glucose levels <70 mg/dL, clinically important hypoglycemia with glucose levels <54 mg/dL and nocturnal (00.00-06.00) hypoglycemia. RESULTS: Considering efficacy, the mean percentage of time for the target glucose range of IDegAsp was significantly lower than that of Gla300/Glu (73.1 [69.4-81.1] vs 84.2 [80.2-93.1], P = 0.001). Considering safety, the mean percentages of hypoglycemia (<70 mg/dL; 2.1 [0.0-9.4] vs 14.4 [4.4-22.3]), clinically important hypoglycemia (<54 mg/dL; 0.0 [0.0-0.2] vs 1.9 [0.0-5.6]) and nocturnal (00.00-06.00 hours) hypoglycemia (0.5 [0.0-5.9] vs 8.9 [3.1-11.8]) of Gla300/Glu were significantly lower than those of IDegAsp (P = 0.012, 0.036 and 0.007, respectively). CONCLUSIONS: When compared with the IDegAsp twice-daily injections, Gla300/Glu basal-bolus therapy might achieve more effective glycemic control without hypoglycemic risk.

Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes.

BACKGROUND: We investigated the efficacy and safety of continuous glucose monitoring (CGM) initiation within 1 year of type 1 diabetes (T1D) diagnosis among children, adolescents, and adults. METHODS: Differences in mean A1c (primary outcome) and diabetes-related emergency visits (secondary outcome) for 2.5 years between early CGM users and non-CGM users were studied among 396 newly diagnosed patients with T1D (94% children [age <18 years], 5% adults, 46% females) between January 2013 and December 2015 at Barbara Davis Center for Diabetes. The primary outcome was adjusted by age at diagnosis and gender. P < 0.05 was considered significant. RESULTS: Gender, ethnicity, body mass index, and A1c at diagnosis were similar between the groups. Irrespective of insulin delivery methods, CGM users had a significantly greater improvement in glycemic control than non-CGM users at 1, 1.5, 2, and 2.5 years. For 2.5 years of follow-up, the multiple daily injection (MDI)+CGM group (n = 19) had 1.5% ± 0.2% lower A1c than the MDI only group (n = 225) (7.7% ± 0.2% vs. 9.2% ± 0.04%, P < 0.0001), and the insulin pump (continuous subcutaneous insulin infusion [CSII])+CGM group (n = 62) had 0.7% ± 0.1% lower A1c than the CSII only group (n = 90) (8.0% ± 0.08% vs. 8.7% ± 0.07%, P < 0.0001). The MDI+CGM group had significantly lower A1c than the CSII only group (7.7% ± 0.2% vs. 8.7% ± 0.07%, P < 0.0001). The number of diabetes-related (severe hypoglycemia or hyperglycemia) emergency department visits was significantly lower among early CGM users compared with non-CGM users (P = 0.003). CONCLUSION: Irrespective of insulin delivery system, early initiation of CGM within 1 year from T1D diagnosis was associated with better glucose control and fewer diabetes-related emergency visits.