-
1.
Influence of Fasting Glucose Levels on Achieving Glycemic Target in Individuals with Type 2 Diabetes: a Post Hoc Analysis.
Ma, J, Lei, M, Li, Y, Zhang, X, Cui, N, Yang, W
Advances in therapy. 2020;(9):3816-3826
Abstract
INTRODUCTION FPG GOAL was a 24-week, open-label, treat-to-target randomized controlled trial which demonstrated that the optimal self-monitored fasting blood glucose (SM-FBG) target for most Chinese individuals with type 2 diabetes (T2D) using insulin glargine 100 IU/mL was 3.9-6.1 mmol/L. Individuals who achieved lower fasting plasma glucose (FPG) levels might achieve the target HbA1c of < 7% without increasing the risk of hypoglycemia. METHODS For this post hoc analysis, individuals were redivided into three groups based on their actual laboratory FPG levels at 24 weeks: level 1, ≤ 5.6 mmol/L; level 2, > 5.6 to ≤ 6.1 mmol/L; and level 3, > 6.1 to ≤ 7.0 mmol/L. RESULTS At week 24, 863 individuals with diabetes had available FPG data and 179, 122, and 179 individuals achieved FPG levels 1, 2, and 3, respectively. The proportion of individuals with HbA1c < 7% or HbA1c < 7% without hypoglycemia (≤ 3.9 or ≤ 3.0 mmol/L) was significantly higher in FPG levels 1 (p < 0.01) and 2 (p < 0.05) than in level 3. The least squares mean changes from baseline in HbA1c (- 1.77% and - 1.66% vs - 1.34%; both p < 0.001) and 2-h postprandial glucose (- 3.88 mmol/L and - 3.98 mmol/L vs - 3.22 mmol/L; both p < 0.05) were also significantly higher in FPG levels 1 and 2 compared with level 3. Linear regression analysis showed a moderate relationship between FPG and HbA1c levels at 24 weeks (r = 0.449). CONCLUSIONS Chinese individuals with T2D who achieved lower FPG levels with insulin glargine 100 IU/mL were more likely to achieve the recommended target HbA1c of < 7% compared with those with higher FPG levels. ClinicalTrials.gov identifier NCT02545842.
-
2.
Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin in type 1 diabetes: meta-analysis of randomised controlled trials.
Musso, G, Gambino, R, Cassader, M, Paschetta, E
BMJ (Clinical research ed.). 2019;:l1328
-
-
Free full text
-
Abstract
OBJECTIVE To assess the efficacy and safety of dual sodium glucose cotransporter (SGLT) 1/2 inhibitor sotagliflozin in type 1 diabetes mellitus. DESIGN Meta-analysis of randomised controlled trials. DATA SOURCES Medline; Cochrane Library; Embase; international meeting abstracts; international and national clinical trial registries; and websites of US, European, and Japanese regulatory authorities, up to 10 January 2019. ELIGIBILITY CRITERIA FOR SELECTING STUDIES Randomised controlled trials evaluating the effect of sotagliflozin versus active comparators or placebo on glycaemic and non-glycaemic outcomes and on adverse events in type 1 diabetes in participants older than 18. Three reviewers extracted data for study characteristics, outcomes of interest, and risk of bias and summarised strength of evidence using the grading of recommendations assessment, development, and evaluation approach. Main outcomes were pooled using random effects models. RESULTS Of 739 records identified, six randomised placebo controlled trials (n=3238, duration 4-52 weeks) were included. Sotagliflozin reduced levels of glycated haemoglobin (HbA1c; weighted mean difference -0.34% (95% confidence interval -0.41% to -0.27%), P<0.001); fasting plasma glucose (-16.98 mg/dL, -22.1 to -11.9; 1 mg/dL=0.0555 mmol/L) and two hour-postprandial plasma glucose (-39.2 mg/dL, -50.4 to -28.1); and daily total, basal, and bolus insulin dose (-8.99%, -10.93% to -7.05%; -8.03%, -10.14% to -5.93%; -9.14%, -12.17% to -6.12%; respectively). Sotagliflozin improved time in range (weighted mean difference 9.73%, 6.66% to 12.81%) and other continuous glucose monitoring parameters, and reduced body weight (-3.54%, -3.98% to -3.09%), systolic blood pressure (-3.85 mm Hg, -4.76 to -2.93), and albuminuria (albumin:creatinine ratio -14.57 mg/g, -26.87 to -2.28). Sotagliflozin reduced hypoglycaemia (weighted mean difference -9.09 events per patient year, -13.82 to -4.36) and severe hypoglycaemia (relative risk 0.69, 0.49 to 0.98). However, the drug increased the risk of ketoacidosis (relative risk 3.93, 1.94 to 7.96), genital tract infections (3.12, 2.14 to 4.54), diarrhoea (1.50, 1.08 to 2.10), and volume depletion events (2.19, 1.10 to 4.36). Initial HbA1c and basal insulin dose adjustment were associated with the risk of diabetic ketoacidosis. A sotagliflozin dose of 400 mg/day was associated with a greater improvement in most glycaemic and non-glycaemic outcomes than the 200 mg/day dose, without increasing the risk of adverse events. The quality of evidence was high to moderate for most outcomes, but low for major adverse cardiovascular events and all cause death. The relatively short duration of trials prevented assessment of long term outcomes. CONCLUSIONS In type 1 diabetes, sotagliflozin improves glycaemic and non-glycaemic outcomes and reduces hypoglycaemia rate and severe hypoglycaemia. The risk of diabetic ketoacidosis could be minimised by appropriate patient selection and down-titration of the basal insulin dose.
-
3.
Weight-based carbohydrate treatment of hypoglycaemia in people with Type 1 diabetes using insulin pump therapy: a randomized crossover clinical trial.
McTavish, L, Corley, B, Weatherall, M, Wiltshire, E, Krebs, JD
Diabetic medicine : a journal of the British Diabetic Association. 2018;(3):339-346
Abstract
AIM: To test whether weight-based treatment is more effective than usual care in people with Type 1 diabetes receiving continuous subcutaneous insulin infusion therapy with regard to both hypoglycaemia and avoiding excessive rebound hyperglycaemia. METHODS Children and adults on continuous subcutaneous insulin infusion were enrolled into a study with a crossover design. Each episode of hypoglycaemia (defined as capillary glucose <4.0 mmol/l) was randomly assigned one of two treatment protocols using glucose tablets: either 0.3 g/kg body weight or usual treatment with 15 g (adults) or 10 g (children) for capillary glucose levels 3-3.9 mmol/l or twice these doses for capillary glucose levels <3 mmol/l. All participants received each treatment in random order for up to 10 hypoglycaemic episodes. Glucose levels were re-tested 10 min after treatment, with a repeat dose if still <4 mmol/l. RESULTS Of the 37 participants enrolled, 35 (aged 6-68 years) completed the study. Twenty-four participants completed all treatment episodes, while 10 participants had <10 hypoglycaemic episodes and two withdrew without data. The mean glucose difference between weight-based and usual treatment after 10 min was 0.33 mmol/l (95% CI 0.005 to 0.66; P=0.047) in adults and 0.45 (95% CI 0.18 to 0.72; P=0.001) in children. The odds ratios for resolution of hypoglycaemia at 10 min with a single treatment using weight-based compared with usual treatment were 3.12 (95% CI 1.38 to 7.02; P=0.0070) in adults and 2.61 (95% CI 1.19 to 5.74; P=0.017) in children. CONCLUSIONS Weight-based treatment using 0.3 g/kg glucose was more effective for symptomatic hypoglycaemia in children and adults with Type 1 diabetes who were using continuous subcutaneous insulin infusion than treatment based on current international recommendations.
-
4.
Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial.
Berkowitz, RI, Marcus, MD, Anderson, BJ, Delahanty, L, Grover, N, Kriska, A, Laffel, L, Syme, A, Venditti, E, Van Buren, DJ, et al
Pediatric diabetes. 2018;(2):191-198
-
-
Free full text
-
Abstract
OBJECTIVE To assess the association of proxies of behavioral adherence to the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) lifestyle program with changes in glycemic control and obesity in a multi-ethnic sample of youth with type 2 diabetes. METHODS The TODAY clinical trial included an intensive lifestyle intervention to promote weight reduction. Adherence was assessed with measures of attendance at intervention sessions and rates of self-monitoring of diet and physical activity by participants and their caregivers. The relation between participant characteristics and consistency of proxies of adherence were examined across 3 phases of intervention. RESULTS A total of 234 TODAY youth were randomized to the lifestyle program. Overall rate of session attendance was approximately 60% of planned sessions. Participants with an adequate dose of session attendance (≥75% attended) did not differ from those who attended <75% of sessions in glycemic control, but did have significantly greater reductions in percent overweight compared with those who attended fewer than 75% of sessions. Rates of self-monitoring were low and additional analysis was not possible. CONCLUSIONS Rates of session attendance were moderate in a lifestyle program for youth with type 2 diabetes, but levels of self-monitoring, considered a key lifestyle change behavior, were low. Glycemic control was not significantly associated with session attendance but reductions in percent overweight were. Given the salience of program attendance and self-monitoring to lifestyle weight management established in other populations, future research is needed to understand, develop, and promote strategies and interventions targeting weight loss to achieve improved glycemic control in youth diagnosed with type 2 diabetes.
-
5.
Closed-Loop Insulin Delivery for Adults with Type 1 Diabetes Undertaking High-Intensity Interval Exercise Versus Moderate-Intensity Exercise: A Randomized, Crossover Study.
Jayawardene, DC, McAuley, SA, Horsburgh, JC, Gerche, A, Jenkins, AJ, Ward, GM, MacIsaac, RJ, Roberts, TJ, Grosman, B, Kurtz, N, et al
Diabetes technology & therapeutics. 2017;(6):340-348
Abstract
BACKGROUND We aimed to compare closed-loop glucose control for people with type 1 diabetes undertaking high-intensity interval exercise (HIIE) versus moderate-intensity exercise (MIE). METHODS Adults with type 1 diabetes established on insulin pumps undertook HIIE and MIE stages in random order during automated insulin delivery via a closed-loop system (Medtronic). Frequent venous sampling for glucose, lactate, ketones, insulin, catecholamines, cortisol, growth hormone, and glucagon levels was performed. The primary outcome was plasma glucose <4.0 mmol/L for ≥15 min, from exercise commencement to 120 min postexercise. Secondary outcomes included continuous glucose monitoring and biochemical parameters. RESULTS Twelve adults (age mean ± standard deviation 40 ± 13 years) were recruited; all completed the study. Plasma glucose of one participant fell to 3.4 mmol/L following MIE completion; no glucose levels were <4.0 mmol/L for HIIE (primary outcome). There were no glucose excursions >15.0 mmol/L for either stage. Mean (±standard error) plasma glucose did not differ between stages pre-exercise; was higher during exercise in HIIE than MIE (11.3 ± 0.5 mmol/L vs. 9.7 ± 0.6 mmol/L, respectively; P < 0.001); and remained higher until 60 min postexercise. There were no differences in circulating free insulin before, during, or postexercise. During HIIE compared with MIE, there were greater increases in lactate (P < 0.001), catecholamines (all P < 0.05), and cortisol (P < 0.001). Ketones increased more with HIIE than MIE postexercise (P = 0.031). CONCLUSIONS Preliminary findings suggest that closed-loop glucose control is safe for people undertaking HIIE and MIE. However, the management of the postexercise rise in ketones secondary to counter-regulatory hormone-induced insulin resistance observed with HIIE may represent a challenge for closed-loop systems.
-
6.
Effects of structured testing versus routine testing of blood glucose in diabetes self-management: A randomized controlled trial.
Nishimura, A, Harashima, SI, Fujita, Y, Tanaka, D, Wang, Y, Liu, Y, Inagaki, N
Journal of diabetes and its complications. 2017;(1):228-233
-
-
Free full text
-
Abstract
AIMS: To compare the effects of structured and routine testing regimens used in self-monitoring of blood glucose (SMBG) on glycemic control and diabetes self-management in insulin-naïve type 2 diabetes patients. METHODS Sixty-two outpatients with insulin-naïve type 2 diabetes were randomly allocated into two less-frequent SMBG usage groups: a structured testing group (STG) and a routine testing group (RTG). Subjects in STG measured 7-points on SMBG for 3 consecutive days once every two months without daily testing; subjects in RTG measured SMBG 3 times each week before breakfast on Monday and Friday and before dinner on Wednesday. The primary endpoint was HbA1c reduction. The secondary endpoints were change in body weight, blood pressure, treatment change, and self-management performance change. RESULTS HbA1c levels were significantly decreased by 0.32% (3.50mmol/mol) in STG, partly because physicians changed medications more actively. In contrast, body weight and systolic/diastolic blood pressure were significantly reduced by 0.94kg and 6.8/4.7mmHg, respectively, in RTG, possibly related to the increased diet and exercise score in RTG. CONCLUSIONS Structured testing without daily testing is beneficial for glycemic control; routine testing 3 times a week is more helpful for daily self-management. In low SMBG frequency usage, these two regimens can be utilized according to individual diabetic conditions.
-
7.
Effects of DPP-4 inhibitor linagliptin and GLP-1 receptor agonist liraglutide on physiological response to hypoglycaemia in Japanese subjects with type 2 diabetes: A randomized, open-label, 2-arm parallel comparative, exploratory trial.
Yabe, D, Eto, T, Shiramoto, M, Irie, S, Murotani, K, Seino, Y, Kuwata, H, Kurose, T, Seino, S, Ahrén, B, et al
Diabetes, obesity & metabolism. 2017;(3):442-447
-
-
Free full text
-
Abstract
Dipeptidyl peptidase-4 (DPP-4) inhibitors reduce the risk of hypoglycaemia, possibly through augmentation of glucose-dependent insulinotropic polypeptide (GIP) action, but not that of glucagon-like peptide-1 (GLP-1) on glucagon secretion. To examine this model in Japanese individuals with type 2 diabetes (T2D), the effects of the DPP-4 inhibitor linagliptin on glucagon and other counter-regulatory hormone responses to hypoglycaemia were evaluated and compared with those of the GLP-1 receptor agonist liraglutide in a multi-centre, randomized, open-label, 2-arm parallel comparative, exploratory trial. Three-step hypoglycaemic clamp glucose tests preceded by meal tolerance tests were performed before and after 2-week treatment with the drugs. Glucagon levels were increased during the hypoglycaemic clamp test at 2.5 mmol/L. This increase was similar in the linagliptin and liraglutide groups, both before and after the 2-week treatment. Changes in other counter-regulatory hormones (ie, growth hormone, cortisol, epinephrine and norepinephrine) were also similar between the groups, but were suppressed substantially after 2-week treatment compared to baseline. In conclusion, we confirmed that the glucagon response to hypoglycaemia was not affected by linagliptin or liraglutide treatment in Japanese individuals with T2D.
-
8.
A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control.
Sato, J, Kanazawa, A, Makita, S, Hatae, C, Komiya, K, Shimizu, T, Ikeda, F, Tamura, Y, Ogihara, T, Mita, T, et al
Clinical nutrition (Edinburgh, Scotland). 2017;(4):992-1000
Abstract
BACKGROUND & AIMS The usefulness of low-carbohydrate diet (LCD) for Japanese patients with type 2 diabetes mellitus (T2DM) has not been fully investigated. Therefore, we compared the effectiveness and safety of LCD with calorie restricted diet (CRD). METHODS This prospective, randomized, open-label, comparative study included 66 T2DM patients with HbA1c >7.5% even after receiving repeated education programs on CRD. They were randomly allocated to either the 130g/day LCD group (n = 33) or CRD group (n = 33). Patients received personal nutrition education of CRD or LCD for 30 min at baseline, 1, 2, 4, and 6 months. Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients (28× ideal body weight calories per day). Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions. Several parameters were assessed at baseline and 6 months after each intervention. The primary endpoint was a change in HbA1c level from baseline to the end of the study. RESULTS At baseline, BMI and HbA1c were 26.5 (24.6-30.1) and 8.3 (8.0-9.3), and 26.7 (25.0-30.0) kg/m2 and 8.0 (7.6-8.9) %, in the CRD and LCD, respectively. At the end of the study, HbA1c decreased by -0.65 (-1.53 to -0.10) % in the LCD group, compared with 0.00 (-0.68 to 0.40) % in the CRD group (p < 0.01). Also, the decrease in BMI in the LCD group [-0.58 (-1.51 to -0.16) kg/m2] exceeded that observed in the CRD group (p = 0.03). CONCLUSIONS Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with T2DM. LCD is a potentially useful nutrition therapy for Japanese patients who cannot adhere to CRD. This trial was registered at http://www.umin.ac.jp/english/ (University Hospital Medical Information Network: study ID number 000010663).
-
9.
Teenage girls with type 1 diabetes have poorer metabolic control than boys and face more complications in early adulthood.
Samuelsson, U, Anderzén, J, Gudbjörnsdottir, S, Steineck, I, Åkesson, K, Hanberger, L
Journal of diabetes and its complications. 2016;(5):917-22
-
-
Free full text
-
Abstract
AIMS: To compare metabolic control between males and females with type 1 diabetes during adolescence and as young adults, and relate it to microvascular complications. METHODS Data concerning 4000 adolescents with type 1 diabetes registered in the Swedish paediatric diabetes quality registry, and above the age of 18years in the Swedish National Diabetes Registry was used. RESULTS When dividing HbA1c values in three groups; < 7.4% (57mmol/mol), 7.4-9.3% (57-78mmol/mol) and >9.3% (78mmol/mol), there was a higher proportion of females in the highest group during adolescence. In the group with the highest HbA1c values during adolescence and as adults, 51.7% were females, expected value 46.2%; in the group with low HbA1c values in both registries, 34.2% were females, p<0.001. As adults, more females had retinopathy, p<0.05. Females had higher mean HbA1c values at diagnosis, 11.2 vs. 10.9% (99 vs. 96mmol/mol), p<0.03, during adolescence, 8.5 vs. 8.2% (69 vs. 66mmol/mol) p<0.01, but not as young adults. CONCLUSIONS Worse glycaemic control was found in adolescent females, and they had a higher frequency of microvascular complications. Improved paediatric diabetes care is of great importance for increasing the likelihood of lower mortality and morbidity later in life.
-
10.
Reduction in short-acting insulin requirement accompanies improved glycemic control with basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes.
Rosenstock, J, Blevins, TC, Bergenstal, RM, Morrow, LA, Qu, Y, Jacober, SJ
Journal of diabetes. 2016;(1):166-9