Non-intensive Insulin Research Articles

Best practices and rationale for expanding Medicaid access to continuous glucose monitoring.

Numerous studies have demonstrated that use of continuous glucose monitoring (CGM) significantly improves overall glycemic control and reduces the frequency and severity of hypoglycemic events in individuals treated with intensive insulin, nonintensive insulin, and noninsulin therapies, with reductions in both all-cause and diabetes-related health care resource utilization and lower costs. However, implementation of CGM including prescribing and assessment of the ambulatory glucose profile to make clinical decisions in primary care settings is low. A recent pilot program was initiated at MetroHealth System (Cleveland, Ohio) to implement a CGM integration program for primary care offices throughout the system. Based on the experience and successes from this health system as well as current literature, rationale will be discussed to support the expansion of CGM to individuals enrolled in all Medicaid programs.

Glucometric parameter changes in patients with type 2 diabetes during ramadan fasting: A prospective comparative real-world study

BackgroundThis study assessed glucometric changes in Type 2 diabetes mellitus (T2DM) patients before, during, and after Ramadan fasting using an intermittently scanned continuous glucose monitoring system (isCGMS). MethodsThis prospective comparative study included T2DM patients aged 30–70 years who were receiving nonintensive insulin in Riyadh, Saudi Arabia. In addition to the baseline characteristics, glycated hemoglobin (HbA1c) and ambulatory glucose profile (AGP)-derived metric data were collected at three specific points: pre-, during-, and post-Ramadan. Self-care activities during Ramadan were evaluated using the Diabetes Self-Management Questionnaire (DSMQ). ResultsOverall, a total of 93 T2DM patients were enrolled in the study. Their mean age ±SD age was 47.9 ± 7.5 years, and 51.6 % of them were males. Compared with pre- and post-Ramadan, there was a significant decrease in HbA1c (p < 0.001 for both periods), average glucose level (p = 0.001 and p = 0.026, respectively), glucose variability (p = 0.043 and p = 0.005, respectively), and % time above the range of 181–250 mg/dL (p < 0.001 for both periods), as well as a significant increase in % time in target (70–180 mg/dL) during Ramadan (p < 0.001 for both periods). However, the % time below 54 mg/dL was slightly greater during Ramadan than both pre- and post-Ramadan (p < 0.001 and p = 0.002, respectively). Furthermore, 32.3 % reported inadequate self-care behaviors during Ramadan. ConclusionsRamadan fasting could improve glucose levels in T2DM patients who were not on intensive insulin, with a relatively low incidence of hypoglycemia.

Initiating GLP-1 Therapy in Combination with FreeStyle Libre Provides Greater Benefit Compared with GLP-1 Therapy Alone.

Background and Aim: Glucagon-like peptide-1 receptor agonists (GLP-1 RA) therapy provides glycemic benefits to individuals with type 2 diabetes (T2D). However, the effects of GLP-1 RA therapy in combination with FreeStyle Libre systems (FSL) are unknown. This study aimed to compare changes in hemoglobin A1c (HbA1c) between people acquiring GLP-1 with FSL (GLP-1+FSL) versus GLP-1 without FSL (GLP-1). Methods: This real-world study used Optum's de-identified Market Clarity Data, a linked electronic health records (EHR)-claims database, and included adults with T2D and HbA1c ≥8% who acquired their first GLP-1 RA medication between 2018 and 2022. GLP-1+FSL subjects acquired their first FSL within ±30 days of their first GLP-1 acquisition. Cohorts were matched 1:5 on baseline insulin therapy, age, sex, baseline HbA1c, and GLP-1 type. Paired changes in HbA1c were compared between unmatched and matched groups at 6 months. Results: The study included 24,724 adults in the unmatched cohort (GLP-1+FSL, n = 478; GLP-1, n = 24,246). The matched cohort included 478 GLP-1+FSL users and 2,390 GLP-1 users: mean age 53.5 ± 11.8 and 53.5 ± 11.3 years, HbA1c 10.25 ± 1.68% and 10.22 ± 1.69%, respectively. HbA1c reduction was greater in the GLP-1+FSL group compared with the GLP-1 group in the unmatched cohort (-2.43% vs. -1.73%, difference 0.70%, P < 0.001, respectively) and in the matched cohort (-2.43% vs. -2.06%, difference 0.37%, P < 0.001). GLP-1+FSL vs. GLP-1 treatment was associated with greater HbA1c reduction in the intensive insulin (-2.32% vs. -1.50%), nonintensive insulin (-2.50% vs. -1.74%), and noninsulin group (-2.46% vs. -1.78%), as well as in patients using semaglutide (-2.73% vs. -1.92%) and dulaglutide (-2.45% vs. -1.71%) GLP-1 RA, all P < 0.001. Conclusions: Adults with suboptimally controlled T2D, initiating GLP-1 RA with FreeStyle Libre, had greater improvement in HbA1c compared with those treated with GLP-1 RA only. These results suggest an additional glycemic benefit of FSL when used with a GLP-1 RA in T2D treatment.

Comparative analysis of clinical symptoms and biochemical alterations in women with polycystic ovary syndrome: assessing the impact of type 1 diabetes versus non-diabetic controls

BackgroundWomen with type 1 diabetes depend on insulin injections throughout their life. However, the recommendation for strict metabolic control of diabetes requires the administration of supra-physiological doses of insulin, which might result in insulin-mediated stimulation of androgen synthesis. Hyperandrogenism in women with type 1 diabetes may be associated with polycystic ovary syndrome (PCOS). This study was performed to investigate PCOS and its associated clinical symptoms and biochemical alterations in women with type 1 diabetes in the Palestinian Territories. This retrospective cohort study consists of 50 women with type 1 diabetes and 50 apparently healthy non-diabetic controls. Questionnaire interviews were conducted. The diagnosis of PCOS was based on chronic anovulation and biochemical evidence of hyperandrogenism. Serum total testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), and insulin were measured by ELISA.ResultsThe mean waist-to-hip ratio and age at menarche were significantly higher in diabetic women than in non-diabetic controls (81.9 ± 7.9 and 13.9 ± 1.6 years vs. 78.8 ± 5.7 and 13.2 ± 1.2 years, and P = 0.045, P = 0.020, respectively). Oligomenorrhea, acanthosis nigricans, seborrhea, and hirsutism were more frequent in diabetics. The levels of total testosterone and insulin were significantly higher in diabetics (0.58 ± 0.11 ng/ml and 15.8 ± 12.4 mlU/ml vs. 0.44 ± 0.11 ng/ml and 10.8 ± 4.5 mlU/ml, P < 0.001 and P = 0.010, respectively). PCOS was present in 11 (22.0%) of diabetic women compared to 3 (6.0%) in non-diabetics (P = 0.044). Diabetic women with PCOS received higher doses of insulin than non-PCOS women (72.7 ± 23.9 vs. 55.0 ± 19.8 UI.cc/ml/day, P = 0.023). PCOS women showed more frequent oligomenorrhea (100% vs. 15.4%, P < 0.001) and higher levels of total testosterone and insulin (0.64 ± 0.09 and 23.1 ± 13.0 vs. 0.53 ± 0.11 and 14.1 ± 11.8, P = 0.023 and P = 0.041, respectively). PCOS cases were significantly more frequent in diabetic women receiving intensive insulin therapy than their counterparts with non-intensive insulin therapy (40.9% vs. 7.1%, P = 0.012).ConclusionIntensive insulin treatment in type 1 diabetes potentiates the development of PCOS and its related clinical and biochemical features particularly oligomenorrhea, hyperinsulinemia, and hyperandrogenemia.

A Podcast on the Use of CGM in Optimizing Type 2 Diabetes Management with Non-intensive Insulin Treatment in the Primary Care Setting.

Type 2 diabetes is a widespread health concern with significant implications for patient well-being. Poor glycaemic control can lead to long-term complications, hypoglycaemia and glycaemic variability, highlighting the importance of setting treatment goals. This podcast, "The use of CGM in optimizing type 2 diabetes management with non-intensive insulin treatment in the primary care setting", introduces non-intensive insulin treatment and continuous glucose monitoring (CGM) as crucial tools in achieving these goals. The advantages of CGM over blood glucose monitoring (BGM) are explored, emphasizing its real-time glucose data provision and how it empowers patients to make informed treatment decisions. Drawing on randomized controlled trials (RCTs), the compelling evidence of CGM's effectiveness in patients with type 2 diabetes on basal insulin treatment are discussed. Additionally, the real-world evidence, comparing outcomes between insulin-treated and non-insulin-treated patients are also addressed. The podcast examines the link between glycaemic control and acute complications requiring hospitalizations and how CGM contributes to a better quality of life for patients with type 2 diabetes. Empowering patients is central to this podcast, with a focus on education, engagement and strategies for integrating CGM data into treatment plans. The pivotal role of healthcare providers in supporting patients on non-intensive insulin treatment and CGM in the primary care setting is addressed. Addressing challenges and barriers in CGM adoption, including cost considerations, technology accessibility and patient concerns, is vital to its widespread use. There is also a consideration of the cost-effectiveness of CGM in type 2 diabetes management. The podcast provides insights into when to consider CGM, including intermittent use and data integration with other health technologies. It emphasizes the potential for improved patient outcomes and a reduced burden of type 2 diabetes. Practical tips for interpreting the Ambulatory Glucose Profile (AGP) report are shared, benefitting primary care healthcare professionals new to CGM. The podcast "The use of CGM in optimizing type 2 diabetes management with non-intensive insulin treatment in the primary care setting" highlights the transformative potential of CGM in type 2 diabetes care. It encourages patients and healthcare providers to consider CGM as an integral part of treatment plans, ultimately improving the lives of those living with type 2 diabetes. Podcast Video (MP4 261831 KB).

A retrospective comparison between intensive and nonintensive insulin regimens in type 2 diabetes mellitus.

This study compared the outcomes between intensive and nonintensive insulin regimens and assessed the predictive factors for failing to achieve the glycated hemoglobin (A1C) goals in type-2-diabetes-mellitus (T2DM) patients requiring insulin therapy. A single-center, retrospective assessment of the medical records of 125 T2DM patients undergoing intensive (46 patients) and nonintensive insulin therapy (79 patients) were conducted. No significant differences were found when the intensive and nonintensive insulin therapy groups were compared in terms of the percentage decreases of glucose and A1C levels. The mean A1C levels of the nonintensive and intensive groups declined from 11.15% and 11.30% to 7.97% and 8.06%, respectively. Both intensive and nonintensive insulin therapies improved the baseline glycemic parameters but being overweight or obese and/or being reluctant to dietary recommendations led to treatment failures regardless of the insulin regimen.

Coverage for Continuous Glucose Monitoring for Individuals with Type 2 Diabetes Treated with Nonintensive Therapies: An Evidence-Based Approach to Policymaking.

Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring (CGM) in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) who are treated with intensive insulin regimens. Based on this evidence, CGM is now a standard of care for individuals within these diabetes populations and widely covered by commercial and public insurers. Moreover, recent clinical guidelines from the American Diabetes Association and American Association of Clinical Endocrinology now endorse CGM use in individuals treated with nonintensive insulin regimens. However, despite increasing evidence supporting CGM use for individuals treated with less-intensive insulin therapy or noninsulin medications, insurance coverage is limited or nonexistent. This narrative review reports key findings from recent randomized, observational, and retrospective studies investigating use of CGM in T2D individuals treated with basal insulin only and/or noninsulin therapies and presents an evidence-based rationale for expanding access to CGM within this population.

677-P: Exploring the Impact of CGM on Perceived Control of Non-Intensive Insulin Treated Type 2 Diabetes—“I liked keeping my line with as few spikes as possible”

Background and Aims: Progression of type 2 diabetes (T2D) demands complex treatment modalities, which may impair patients’ confidence and psychological health. Technologies allowing improved understanding of the dynamic disease process may improve engagement with therapy. Methods: As part of a larger observational study, we previously reported findings highlighting the impact of using Dexcom G6 real-time CGM (rtCGM) with T2D adults (diverse therapies) and prediabetes over a 12-week period. We now explored qualitative data generated from a subsample of T2D participants (N=38) on non-intensive insulin therapy (Basal only=24%, No insulin=76%). Participants answered open-ended questions about their experiences using CGM including self-reported learnings and changes in behavior. Primary themes from qualitative data were derived using content analysis and confirmed with inter-coder reliability. Results: Overall, most participants (&amp;gt;90%) ended the study with high levels of perceived control (PC) of their diabetes. For further analysis, participants’ change in PC at study end were plotted based on low, medium, or high PC before CGM use. Interesting group differences emerged wherein fewer participants reporting medium PC at baseline reported high PC at study end (vs. others with low and high baseline PC). Qualitative themes around perceived illness severity, depressive symptoms, and self-efficacy along with differences in demographics and glycemic metrics helped translate these meaningful findings. Conclusions: rtCGM use provided valuable improvements in participants’ engagement and understanding of their diabetes with potential for long-term clinical benefits. Future studies exploring relationships between perceived control of diabetes and progression of T2D may indicate potential areas for improved engagement with diabetes technology. Disclosure M.A.Crawford: Employee; Dexcom, Inc. C.Hicks: Employee; Dexcom, Inc. P.Genge: Employee; Dexcom, Inc. K.Greenawald: Employee; Dexcom, Inc. M.Tressler: Employee; Dexcom, Inc. D.R.Cherñavvsky: None. H.Singh: Employee; Tandem Diabetes Care, Inc., Dexcom, Inc. Funding Dexcom, Inc.

227-OR: Increasing Quarterly Use of Intermittent CGM among Individuals with T2D Is Associated with Improved Glycemic Control over a One-Year Time Frame

Introduction: Continuous glucose monitoring (CGM) is an important tool for biofeedback in diabetes self-management. Intermittent use CGM for T2D users is one approach to address cost and access limitations, but to date only limited evidence supports intermittent use. The objective of this study was to understand the impact of intermittent use CGM in T2D non-intensive insulin users in a real-world setting. Methods: As part of an ongoing implementation study within the Livongo whole person digital health program, a select population of individuals living with T2D who had not previously used CGM and either used no insulin or basal insulin only were mailed and asked to wear Dexcom G6 CGM sensors for 7-10 days per quarter for 4 consecutive quarters. In this analysis, we examined data from 227 individuals who adhered to wearing CGM for at least 7 days in 2 or more quarters. A multiple linear regression design quantified the impact of the primary variable of interest - the number of quarters with CGM wear (2, 3, or 4) - on changes in glycemic control between the first and latest available sensors, while including additional variables (potential confounds) associated with demographic traits, medication use, and temporal aspects of CGM wear. Results: Glycemic control at baseline varied widely; 54% of individuals had a Time In Range (TIR) less than the target of 70%. Among the full sample (N = 227), each additional quarter of CGM use (beyond 2) resulted in clinically meaningful average improvements (and significant partial correlations, all p &amp;lt; .05) in mean sensor glucose (11.8 mg/dL decrease), TIR (7.7 point increase), Time Above Range (7.9 point decrease), and the Glycemia Risk Index (9.3 point decrease). Conclusion: Type 2 non-intensive insulin users who were adherent to quarterly use of intermittent CGM over one year saw meaningful improvements in glycemic control. Providing access to CGM technology may facilitate improvement in outcomes and disease management. Disclosure R.J.Ellis: Employee; Teladoc Health. T.Kompala: Employee; Teladoc Health, Stock/Shareholder; Teladoc Health. R.J.Brooks: Employee; Teladoc Health, Stock/Shareholder; Dexcom, Inc. J.Hone: Employee; Teladoc Health, UnitedHealth Group. A.Salehi: Employee; Teladoc Health. R.James: Employee; Teladoc Health.

Glycaemia in low-premixed insulin analogue type 2 diabetes patients in a real-world setting: are the CGM targets met?

BackgroundThere are insufficient data on continuous glucose monitoring (CGM) in nonintensive insulin therapy patients. Using CGM and the recommended CGM targets, we wanted to evaluate low-premix insulin analogue therapy (biphasic aspart/NovoMix 30 and biphasic lispro 25/Humalog Mix 25) in real-world type 2 diabetes patients for glycaemic efficacy and especially hypoglycaemia.MethodsThe prospective observational study was performed on 35 patients who were treated with a low-premixed insulin. We used the Dexcom G6 system for CGM (9.6 ± 1 days) to measure the clinically relevant CGM parameters: glycaemic variability (%CV), TBR (time below range) < 3.0 mmol/l = 54 mg/dl (level 2 hypoglycaemia), TBR 3.0–3.8 (= 54–69 mg/dl), TIR (time in range) 3.9–10–0 mmol/l (70–180 mg/dl), TAR (time above range) 10–13.9 mmol/l (180–250 mg/dl) and TAR > 13.9 mmol/l (250 mg/dl). We also assessed clinical and demographic characteristics, laboratory HbA1c, fasting blood glucose, peak postprandial glucose values, and the percentage of hypoglycaemia between 00:00 and 06:00.ResultsIn our patients, the average ± SD age was 70.4 ± 9.2 years, diabetes duration 17.4 ± 7.1 years, 51% were females, average daily insulin dose was 46.4 units (80% received biphasic aspart). The average ± SD TIR was 62.1 ± 12.2%, TBR < 3.0 mmol/l 0.8 ± 2.0%, TBR 3.0–3.8 mmol/l 1.5 ± 1.5%, TAR 10–13.9 mmol/l 29.2 ± 12.4%, TAR > 13.9 mmol/l 6.4 ± 7.2% and %CV 29.9 ± 7.1%. The average time in hypoglycemia was 33.1 min daily in our patients (11.5 min in the level 2 range). In the older/high-risk population, the TBR/TIR/TAR/level 2 TAR targets were met in 40/80/77/80%, respectively. For the general T2D people, level 2 TBR/TBR/TIR/TAR/level 2 TAR would be met in 74/83/34/77/49%. Average fasting blood glucose was 8.0 ± 2.5 mmol/l (144 ± 45 mg/dl), BMI 31.3 ± 5.1 kg/m2, daily insulin dose 46.4 ± 12.1 units, HbA1c 57.4 ± 5.4 mmol/mol (7.4 ± 0.7%). The glycaemic variability goal was met in 80% (with 66% meeting the lower 33% CV goal). 17 ± 12% of hypoglycaemia was nocturnal. People with TBR > 4% were significantly older.ConclusionsMost of our type 2 diabetes patients, treated with low-premixed insulin, did not meet the recommended TBR target for older/high-risk patients while meeting the TIR and TAR targets. Nevertheless, the time spent in (total and nocturnal) hypoglycemia was short. The study indicates that the general type 2 diabetes population targets would mostly be met for TBR and %CV in our patients but not the TIR and TAR targets. CGM appears to be a useful clinical tool in these patients.

Il monitoraggio in continuo della glicemia: stato dell’arte

Continuous glucose monitoring (CGM) system is largely used in clinical practice in patients with type 1 diabetes and insulin-treated patients with type 2 diabetes. It is a needful tool for a more comprehensive assessment of glucose control. Patients can benefit from real-time information on current glucose, glucose trend, and hypo or hyperglycemia alarms. Healthcare can rapidly understand how much time patients spend in a good glucose range, hypoglycemia or hyperglycemia. Several clinical trials have demonstrated the benefits of CGM in reducing glycated hemoglobin, as well as the time spent in hypoglycemia, and increasing the time in range. CGM reduces the rate of severe acute complications and hospital admission improving the quality of life. Patients on insulin treatment and pregnant women are the perfect candidates for CGM. However, even patients on non-intensive insulin treatment or other therapies might benefit from CGM to gain and maintain reasonable glycemic control, and again improve the quality of life.

Abstract #1324365: Use of Flash Glucose Monitoring and Glycemic Control in Nonintensive Insulin Regimen Treated Patients with T2DM: One Year Real-Life Retrospective Cohort Study

Regular monitoring and measurement of glucose levels are required to ensure reasonable glycemic control and to prevent diabetes-related complications in patients. The Freestyle LibreTM flash glucose monitoring (FGM) system has significantly improved self-management by providing real-time access to their glucose profiles and guiding necessary steps for management based on the retrieved data. The term ‘glucose management indicator’ (GMI) was proposed to replace estimated A1c to avoid a misinterpretation that the value of this metric should always closely match a corresponding laboratory-measured A1c.

A retrospective comparison between intensive and non-intensive insulin regimens in type 2 diabetes mellitus

Background This study compared the outcomes between intensive and non-intensive insulin regimens and assessed the predictive factors for failing to achieve the glycated hemoglobin (A1C) goals in type 2 diabetes mellitus (T2DM) patients requiring insulin therapy. Methods A single-center, retrospective assessment of the medical records of 125 T2DM patients undergoing intensive (46 patients) and non-intensive insulin therapy (79 patients) were conducted. Results No significant differences were found when the intensive and non-intensive insulin therapy groups were compared in terms of the percentage decreases of glucose and A1C levels. The mean A1C levels of the non-intensive and intensive groups declined from 11.15% and 11.30% to 7.97% and 8.06%, respectively. Conclusions Both intensive and non-intensive insulin therapies improved the baseline glycemic parameters, but being overweight or obese and/or being reluctant to dietary recommendations led to treatment failures regardless of the insulin regimen.

Effects of different triglyceride-lowering therapies in patients with hypertriglyceridemia-induced acute pancreatitis.

The aim of the present study was to investigate the effects of various triglyceride (TG)-lowering therapies on hypertriglyceridemia-induced acute pancreatitis (HTGAP). A total of 132 patients with HTGAP were retrospectively divided into an insulin intensive therapy (IIT), a plasma exchange (PE) and a non-intensive insulin therapy (NIIT) group according to the TG-lowering therapies they had received. The clinical and biochemical data of the subjects were analyzed. The baseline data, including sex, age, TG, amylase, severe acute pancreatitis and systemic inflammatory response syndrome were not significantly different among the three groups (P>0.05). The 24-h TG clearance rate (χ2=7.74, P=0.021), onset to treatment time (χ2=14.50, P<0.001) and the time required to reach the target TG level (χ2=6.12, P=0.047) were different in these three groups, but no significant differences were observed between the IIT and NIIT groups (P>0.05). The incidence of therapy-associated complications in the PE group (30.23%) was higher than that in the IIT (2.17%) and NIIT (4.65%) groups. The difference in the incidence of therapy-associated complications was significant among the three groups (P<0.001), but no significant difference was present between the IIT and NIIT groups (P>0.05). In the PE group, the length of stay was increased compared with that in the IIT and NIIT groups (χ2=7.05, P<0.05), while there was no significant difference between the IIT and NIIT groups (P>0.05). The present study suggested that NIIT at presentation had a similar therapeutic efficacy to that of IIT to improve the prognosis of HTGAP, and NIIT and IIT were associated with fewer complications than PE treatment. NIIT may favorably perform in patients presenting early after symptom onset and may be considered for clinical application.

One-Year Outcome of Intensive Insulin Therapy Combined to Glucose-Insulin-Potassium in Acute Coronary Syndrome: A Randomized Controlled Study.

BackgroundA number of factors may offset the cardioprotective effects of glucose‐insulin‐potassium (GIK) on outcome of patients with acute coronary syndrome, such as hyperglycemia induced by this cocktail infusion. We performed a study to evaluate the effect of intensive insulin therapy in association with GIK on 1‐year outcome in patients hospitalized for acute coronary syndrome.Methods and ResultsIn a randomized prospective controlled trial we included 772 patients with non–ST‐segment elevation acute coronary syndrome. Patients were randomized into 3 groups: GIKI2 group, who received GIK with intensive insulin therapy for 24 hours; GIK group, who received GIK with nonintensive insulin therapy; and control group, who received usual care. The primary outcome criteria were the rates of major cardiovascular events combining death, reinfarction, and stroke rate at 1 year. In addition, we measured platelet function assay‐100 and plasminogen activator inhibitor‐1 at admission and 24 hours later. Based on an intention‐to‐treat analysis, major cardiovascular events at 1 year was 12.8% in the GIKI2 group, 15.5% in the GIK group, and 20.5% in the placebo group; the difference was significant between the GIK2 and control groups (P=0.01). Platelet function assay‐100 at 24 hours decreased significantly from baseline in the control group but not in the GIKI2 group. Plasminogen activator inhibitor‐1 decreased significantly in the GIKI2 group but significantly increased in the control group. Minor hypoglycemic events were more frequent in the GIKI2 group compared with other groups.ConclusionsGIKI2 led to improvement of 1‐year outcome rates in patients with non–ST‐segment elevation acute coronary syndrome. This beneficial effect was associated with a decrease in platelet reactivity and an increase on fibrinolysis tests.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT00965406.

Predictors of glycemic control in the first year of diagnosis of childhood onset type 1 diabetes: A systematic review of quantitative evidence.

Early glycemic control is associated with reduced future vascular complications risk in type 1 diabetes (T1D). The aim of this study was to systematically review evidence on the predictors of glycemic control within 12 months of diagnosis of childhood onset T1D. Inclusion criteria for the electronic search were: interventional and observational studies that assessed and quantified an association between the predictor and glycemic control within 12 months of diagnosis of childhood onset T1D. A total of 17 915 articles were identified from 6 databases and 20 studies were finally included in the analysis. Harvest plots and narrative synthesis were used to summarize data from intervention (n = 0), prospective/retrospective cohort (n = 15), and cross-sectional (n = 5) studies. Significant predictors of poorer glycemic control 0 to 3 months after diagnosis were older age and female gender. Non-white ethnicity, diabetes autoantibody positivity, measures of deprivation, and non-private health insurance were potential predictors. Predictors of poorer glycemic control 4 to 12 months after diagnosis were: older age, non-white ethnicity, a single parent family, high hemoglobin A1c (HbA1c) levels at diagnosis, longer T1D duration, and non-intensive insulin therapy. Potential predictors included: family with health issues, clinical factors, and comorbidities at diagnosis. Most significant predictors of poor glycemic control within 12 months of diagnosis of childhood onset T1D are non-modifiable. These factors need to be recognized and addressed through individualized and multidisciplinary diabetes care. Further research is required to confirm the association of potential predictors with early glycemic control.

The effect of an education programme (MEDIAS 2 BSC) of non-intensive insulin treatment regimens for people with Type2 diabetes: a randomized, multi-centre trial.

A self-management oriented education programme (MEDIAS2BSC) for people with Type2 diabetes who are on a non-intensive insulin treatment regimen was developed. In a randomized, multi-centre trial, the effect of MEDIAS2BSC was compared with an established education programme that acted as a control group. The primary outcome was the impact of MEDIAS2BSC on glycaemic control. Secondary outcomes included the incidence of severe hypoglycaemia, hypoglycaemia unawareness, diabetes-related distress, diabetes knowledge, quality of life and self-care behaviour. In total, 182 participants were randomized to the control group or MEDIAS2BSC [median age 64.0 (interquartile range 58.0-68.5) vs. 63.5 (57.0-70.0)years; HbA1c 62.8±12.7mmol/mol vs. 63.7±14.0mmol/mol; 7.9%±1.2% vs. 8.0%±1.3%]. After a 6-month follow-up, there was a mean decrease in HbA1c of 3.5mmol/mol (0.32%) in the control group and 6.7mmol/mol (0.61%) in MEDIAS2BSC. After adjusting for baseline differences and study centre, the mean difference between the groups was -3.3mmol/mol [95% confidence interval (CI) -0.54 to -5.90mmol/mol] [-0.30% (95% CI -0.05 to -0.54)] in favour of MEDIAS2BSC (P=0.018). There were no increases in severe hypoglycaemia or hypoglycaemia unawareness. The education programmes had no significant effects on psychosocial outcome variables. MEDIAS2BSC was more effective in lowering HbA1c than the control condition. MEDIAS2BSC is a safe educational tool that improves glycaemic control without increasing the risk for hypoglycaemia. (Clinical Trials Registry No; NCT 02748239).

Intensive versus nonintensive insulin therapy for hyperglycemia after traumatic brain injury: study protocol for a randomized controlled trial

Background: Hyperglycemia after traumatic brain injury is a physiological and metabolic disorder that may further aggravate secondary injury to the brain. Various experiences in the effective treatment of hyperglycemia after traumatic brain injury have been described. For example, the early use of intensive insulin therapy can control the blood glucose concentration within the target range, which has a direct protective effect on severe traumatic brain injury. However, some studies have arrived at different conclusions. Therefore, we aim to verify the therapeutic efficacy of intensive insulin therapy versus nonintensive insulin therapy on hyperglycemia after severe traumatic brain injury. Methods/Design: A randomized, controlled, double-blind study has been designed for completion at Oriental Hospital of Lianyungang, China. Sixty patients with hyperglycemia after severe closed traumatic brain injury will be randomized into an intensive insulin therapy group and a nonintensive insulin therapy group. The intensive insulin therapy group will then be divided into three subgroups based on the following target blood glucose levels: 4.4-7.0 mM (strict control group), 7.1-10.0 mM (moderate control group), and 10.1- 3.0 mM (slight control group). In the intensive insulin therapy group, the blood glucose levels will be monitored and controlled using the Yale Insulin Infusion Protocol, and a micropump will be used for intravenous injection of insulin. The nonintensive insulin therapy group will be given subcutaneous insulin injections. The primary endpoint will be the blood glucose levels, and the secondary endpoints will be mortality, activities of daily living, and prognosis. Discussion: This study will be powered to confirm the advantages of intensive insulin therapy in controlling blood glucose levels, reducing mortality, and improving prognosis in patients with hyperglycemia after severe traumatic brain injury. Trial registration: ClinicalTrials.gov identifier: NCT02161055; registered on 5 June 2014.

Target-seeking behavior of plasma glucose with exercise in type 1 diabetes.

To investigate the reproducibility of the plasma glucose (PG) response to exercise in subjects with type 1 diabetes on a nonintensive insulin regimen. Subjects cycled for 45 min at 50% VO(2max) on two occasions (studies 1 and 2) either 1 h after lunch and usual insulin (protocol A) or after overnight fasting without morning insulin (protocol B). Identical diet, activity, and insulin (twice daily neutral and intermediate) were maintained before and during each study day. A total of 13 type 1 diabetic subjects (6 men and 7 women, BMI 24.0 +/- 0.9 kg/m(2) [means +/- SE], age 42.6 +/- 2.7 years, diabetes duration 14.1 +/- 2.8 years) completed protocol A, and 7 (3 men and 4 women, BMI 25.8 +/- 1.3 kg/m(2), age 39.7 +/- 1.3 years, diabetes duration 14 +/- 4.4 years) completed protocol B. In protocol A (fed), the fall in PG during exercise was 4.5 +/- 1.0 and 5.0 +/- 0.8 mmol/l in studies 1 and 2, respectively, whereas in protocol B (fasted), it was 0.6 +/- 0.8 and 3.4 +/- 1.6 mmol/l. Regression analysis of the change in PG in protocol A in study 1 versus study 2 showed poor reproducibility (r(2) = 0.12, P = 0.25) despite uniform conditions. In protocol B, the fall in PG was more reproducible (r(2) = 0.81, P = 0.006). In fed subjects, there was better (P = 0.01) and clinically useful reproducibility of the PG at exercise completion (r(2) = 0.77, P = 0.0001) compared with preexercise. These results indicate poor reproducibility of the change in PG during exercise after feeding in type 1 diabetes on nonintensive insulin regimens but reasonable reproducibility when fasting. Exercise apparently decreases the glycemic variability after feeding, so that PG concentrations after exercise seek a reproducible "target." Thus, the absolute PG level after a typical bout of exercise in the fed state should be a good guide to carbohydrate or insulin adjustment on subsequent occasions.

Nocturnal blood glucose control in type I diabetes mellitus.

A major problem in replacing insulin in type I diabetes mellitus is that currently no depot preparation exists that is capable of mimicking the background insulin secretion of the healthy pancreas. Because all of the currently available intermediate- or long-acting insulin preparations have a peaked-action profile, excess insulin action at midnight and insulin waning at dawn occur whenever such an insulin preparation is given at supper time. If the target fasting plasma glucose is the ambitious near-normoglycemia of intensive insulin therapy, intermediate-acting insulin at suppertime easily results in hypoglycemia in the early evening hours and hyperglycemia in the fasting state. The problems of overnight glycemia in type I diabetes are further complicated by the dawn phenomenon and the Somogyi phenomenon. The dawn phenomenon is the combination of an initial decrease in insulin requirements between approximately 2400 and approximately 0300, followed by an increase in the insulin needs between approximately 0500 and approximately 0800. The dawn phenomenon is the result of changes in hepatic (and extrahepatic) insulin sensitivity, which are best attributed to nocturnal growth hormone secretion. The dawn phenomenon is a day-to-day reproducible event that occurs in nearly all diabetic patients. Its contribution to fasting hyperglycemia correlates with diabetes duration (inversely) and the HbA1c percentage (directly). Overall, it is estimated that the specific contribution of the dawn phenomenon to fasting hyperglycemia is approximately 2 mM (approximately 35 mg/dl), but it may be much greater because of the warning of the depot-insulin preparation injected the previous evening. The Somogyi phenomenon, strictly speaking, refers to fasting hyperglycemia that occurs after inducement of nocturnal hypoglycemia by regular insulin. Because the present therapeutic regimens of NPH/Lente insulin given at suppertime cause overnight hyperinsulinemia, excessive fasting hyperglycemia rarely follows nocturnal hypoglycemia, except when excessive glucose is ingested to correct hypoglycemia. However, nocturnal hypoglycemia may easily deteriorate glycemic control later in the day, because it induces prolonged posthypoglycemic insulin resistance, which results in postbreakfast and late-morning hyperglycemia. With nocturnal insulin therapy, it is important to consider the problems of insulin pharmacokinetics, the dawn phenomenon, and the Somogyi phenomenon to prevent both nocturnal hypoglycemia and excessive fasting hyperglycemia.(ABSTRACT TRUNCATED AT 400 WORDS)