scholarly journals Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e018493 ◽  
Author(s):  
Ruth C E Hughes ◽  
Janet Rowan ◽  
Jonathan Williman
Keyword(s):  
Blood Glucose ◽  
New Zealand ◽  
Early Intervention ◽  
Caesarean Section ◽  
Outcome Measures ◽  
Standard Care ◽  
Intervention Group ◽  
Blood Glucose Monitoring ◽  
Oral Glucose ◽  
Early Intervention Group

ObjectiveMeasurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes.SettingTwo tertiary referral centres in New Zealand.ParticipantsWomen <14 weeks’ gestation and HbA1c ≥5.9%–6.4% (41–46 mmol/mol) measured at booking, without pre-existing diabetes.InterventionsRandomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks’ gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy.Outcome measuresRecruitment rate, adherence to protocol and validation of potential primary outcomes.ResultsRecruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement.ConclusionsFor a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and healthcare costs.Trial registration numberACTRN12615000904572; Pre-results.

scholarly journals Community Pharmacist-Provided Wellness and Monitoring Services in an Employee Wellness Program: A Four-Year Summary

Pharmacy ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 80
Author(s):  
Yifei Liu ◽  
Kendall D. Guthrie ◽  
Justin R. May ◽  
Kristen L. DiDonato
Keyword(s):  
Blood Pressure ◽  
Blood Glucose ◽  
Outcome Measures ◽  
Blood Pressure Monitoring ◽  
Density Lipoprotein ◽  
Blood Glucose Monitoring ◽  
Employee Wellness ◽  
Wellness Program ◽  
Monitoring Group ◽  
Employee Wellness Program

Objective: To assess the clinical outcomes of participants of an employee wellness program during four years of service implementation. Methods: A prospective cohort study was conducted at 15 independent community pharmacy chain locations in northwest and central Missouri. A total of 200 participants were enrolled in an employee wellness program, and the program included five monitoring groups—cholesterol, blood pressure, blood glucose, weight, and healthy participant groups. Participants selected a pharmacist wellness coordinator and wellness appointments were conducted, consisting of education, goal-setting, and monitoring through physical assessment and point of care testing. The primary outcome measures were total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting blood glucose (FBG), body mass index (BMI), and waist circumference (WC). The secondary outcome measures were the proportion of patients who achieved the clinical value goals at baseline versus 48 months. The primary outcome measures among data collection time points were compared using one-way analysis of variance (ANOVA) tests, and the secondary outcomes were compared between baseline and 48 months by Chi-square or Fisher’s exact tests. One-way ANOVA post hoc tests were also performed using least significant difference, to further identify which time points differed from each other. Results: At baseline, there were 134 patients in the cholesterol monitoring group, 129 in the weight monitoring group, 117 in the blood pressure monitoring group, 46 in the blood glucose monitoring group, and 26 in the healthy participant monitoring group. For patients in the blood pressure monitoring group, compared with baseline, there was a significant decrease in DBP at months 12, 24, 36, and 48, and a significant increase in the proportion of patients achieving blood pressure goals at 48 months. For patients in the blood glucose monitoring group, compared with baseline, there was a significant decrease in FBG at months 12, 24, 36, and 48, and a significant increase in the proportion of patients achieving blood glucose goals at 48 months. Conclusions: Pharmacist-led wellness visits provided to employee wellness patients in a community pharmacy may lead to improvements in BP and FBG values.

Ulcus cruris venosum: Was bringt die frühzeitige endovenöse Ablation bei venösen Ulzerationen?

2022 ◽  
pp. 1-2
Author(s):  
Markus Stücker
Keyword(s):  
Early Intervention ◽  
Intervention Group ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Ulcer Recurrence ◽  
Venous Reflux ◽  
Endovenous Ablation ◽  
Quality Adjusted Life ◽  
Early Intervention Group

<b>Importance:</b> One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. <b>Objective:</b> To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. <b>Design, Setting, and Participants:</b> Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months’ duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. <b>Interventions:</b> Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n  =  224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n  =  226). Endovenous modality and strategy were left to the preference of the treating clinical team. <b>Main Outcomes and Measures:</b> The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. <b>Results:</b> The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57–1.17; P  =  .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480–0.898; P  =  .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12–1.64; P  =  .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. <b>Conclusions and Relevance:</b> Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. <b>Trial Registration:</b> ClinicalTrials.gov identifier: ISRCTN02335796.

Daily mycoprotein consumption for 1 week does not affect insulin sensitivity or glycaemic control but modulates the plasma lipidome in healthy adults: a randomised controlled trial

2020 ◽  
Vol 125 (2) ◽  
pp. 147-160
Author(s):  
Mariana O. C. Coelho ◽  
Alistair J. Monteyne ◽  
Marlou L. Dirks ◽  
Tim J. A. Finnigan ◽  
Francis B. Stephens ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Insulin Sensitivity ◽  
Glycaemic Control ◽  
Healthy Adults ◽  
Blood Glucose Monitoring ◽  
Whole Body ◽  
Control Group ◽  
Oral Glucose ◽  
Post Intervention ◽  
The Impact

AbstractMycoprotein consumption has been shown to improve acute postprandial glycaemic control and decrease circulating cholesterol concentrations. We investigated the impact of incorporating mycoprotein into the diet on insulin sensitivity (IS), glycaemic control and plasma lipoprotein composition. Twenty healthy adults participated in a randomised, parallel-group trial in which they consumed a 7 d fully controlled diet where lunch and dinner contained either meat/fish (control group, CON) or mycoprotein (MYC) as the primary source of dietary protein. Oral glucose tolerance tests were performed pre- and post-intervention, and 24 h continuous blood glucose monitoring was applied throughout. Fasting plasma samples were obtained pre- and post-intervention and were analysed using quantitative, targeted NMR-based metabonomics. There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS or 24 h glycaemic profiles. No differences between groups were found for 171 of the 224 metabonomic targets. Forty-five lipid concentrations of different lipoprotein fractions (VLDL, LDL, intermediate-density lipoprotein and HDL) remained unchanged in CON but showed a coordinated decrease (7–27 %; all P < 0·05) in MYC. Total plasma cholesterol, free cholesterol, LDL-cholesterol, HDL2-cholesterol, DHA and n-3 fatty acids decreased to a larger degree in MYC (14–19 %) compared with CON (3–11 %; P < 0·05). Substituting meat/fish for mycoprotein twice daily for 1 week did not modulate whole-body IS or glycaemic control but resulted in changes to plasma lipid composition, the latter primarily consisting of a coordinated reduction in circulating cholesterol-containing lipoproteins.

scholarly journals Cost-effectiveness of an early intervention service for people with psychosis

2010 ◽  
Vol 196 (5) ◽  
pp. 377-382 ◽  
Author(s):  
Paul McCrone ◽  
Tom K. J. Craig ◽  
Paddy Power ◽  
Philippa A. Garety
Keyword(s):  
Quality Of Life ◽  
Early Intervention ◽  
Cost Effectiveness ◽  
Standard Care ◽  
Intervention Group ◽  
Cost Effective ◽  
Care Group ◽  
Early Intervention Service ◽  
Intervention Service

BackgroundThere is concern that delaying treatment for psychosis may have a negative impact on its long-term course. A number of countries have developed early intervention teams but there is limited evidence regarding their cost-effectiveness.AimsTo compare the costs and cost-effectiveness of an early intervention service in London with standard care.MethodIndividuals in their first episode of psychosis (or those who had previously discontinued treatment) were recruited to the study. Clinical variables and costs were measured at baseline and then at 6- and 18-month follow-up. Information on quality of life and vocational outcomes were combined with costs to assess cost-effectiveness.ResultsA total of 144 people were randomised. Total mean costs were £11 685 in the early intervention group and £14 062 in the standard care group, with the difference not being significant (95% CI –£8128 to £3326). When costs were combined with improved vocational and quality of life outcomes it was shown that early intervention would have a very high likelihood of being cost-effective.ConclusionsEarly intervention did not increase costs and was highly likely to be cost-effective when compared with standard care.

Diabetes Screening: Detection and Application of Saliva 1,5-Anhydroglucitol by Liquid Chromatography–Mass Spectrometry

2020 ◽  
Vol 105 (6) ◽  
pp. 1759-1769
Author(s):  
Chaohui Jian ◽  
Aihua Zhao ◽  
Xiaojing Ma ◽  
Kun Ge ◽  
Wei Lu ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
Blood Glucose ◽  
Blood Glucose Monitoring ◽  
Youden Index ◽  
Oral Glucose ◽  
Diabetes Screening ◽  
Liquid Chromatography Mass Spectrometry ◽  
Optimal Cutoff ◽  
Chromatography Mass Spectrometry

Abstract Context Unlike other commonly used invasive blood glucose–monitoring methods, saliva detection prevents patients from suffering physical uneasiness. However, there are few studies on saliva 1,5-anhydroglucitol (1,5-AG) in patients with diabetes mellitus (DM). Objective This study aimed to evaluate the effectiveness of saliva 1,5-AG in diabetes screening in a Chinese population. Design and Participants This was a population-based cross-sectional study. A total of 641 subjects without a valid diabetic history were recruited from September 2018 to June 2019. Saliva 1,5-AG was measured with liquid chromatography–mass spectrometry. Main outcome measures DM was defined per American Diabetes Association criteria. The efficiency of saliva 1,5-AG for diabetes screening was analyzed by receiver operating characteristic curves, and the optimal cutoff point was determined according to the Youden index. Results Saliva 1,5-AG levels in subjects with DM were lower than those in subjects who did not have DM (both P &lt; .05). Saliva 1,5-AG was positively correlated with serum 1,5-AG and negatively correlated with blood glucose and glycated hemoglobin (HbA1c) (all P &lt; .05). The optimal cutoff points of saliva 1,5-AG0 and 1,5-AG120 for diabetes screening were 0.436 μg/mL (sensitivity: 63.58%, specificity: 60.61%) and 0.438 μg/mL (sensitivity: 62.25%, specificity: 60.41%), respectively. Fasting plasma glucose (FPG) combined with fasting saliva 1,5-AG reduced the proportion of people who required an oral glucose tolerance test by 47.22% compared with FPG alone. Conclusion Saliva 1,5-AG combined with FPG or HbA1c improved the efficiency of diabetes screening. Saliva 1,5-AG is robust in nonfasting measurements and a noninvasive and convenient tool for diabetes screening.

scholarly journals Butyrate induced Tregs are capable of migration from the GALT to the pancreas to restore immunological tolerance during type-1 diabetes

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Neenu Jacob ◽  
Shivani Jaiswal ◽  
Deep Maheshwari ◽  
Nayudu Nallabelli ◽  
Neeraj Khatri ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Early Intervention ◽  
Lymph Nodes ◽  
Intervention Group ◽  
Nod Mice ◽  
Immunological Tolerance ◽  
Protective Effects ◽  
Onset Of Diabetes ◽  
Early Intervention Group

Abstract Type-1 diabetes (T1D) is an autoimmune disease caused by progressive loss of insulin-producing beta cells in the pancreas. Butyrate is a commensal microbial-derived metabolite, implicated in intestinal homeostasis and immune regulation. Here, we investigated the mechanism of diabetes remission in non-obese diabetic (NOD) mice following butyrate administration. Sodium butyrate (150 mM) was administered to female NOD mice in drinking water after the onset of hyperglycemia (15–25 weeks age) and at 4 weeks of age (early-intervention group). Butyrate administration reduced the progression of hyperglycemia in diabetic mice and delayed onset of diabetes in the early-intervention group with a reduction in insulitis. Butyrate administration increased regulatory T cells (Tregs) in the colon, mesenteric lymph nodes, Peyer’s patches, and its protective effects diminished upon depletion of Tregs. Further, an increase in α4β7, CCR9, and GPR15 expressing Tregs in the pancreatic lymph nodes (PLN) and pancreas in butyrate-treated mice suggested migration of gut-primed Tregs towards the pancreas. Finally, the adoptive transfer experiments demonstrated that induced Tregs from gut-associated lymphoid tissue can migrate towards the pancreas and PLN and delay the onset of diabetes. Our results thus suggest that early administration of butyrate can restore immunological tolerance during T1D via induction of Tregs with migratory capabilities.

scholarly journals Noninvasive Monitoring of Glucose Using Near-Infrared Reflection Spectroscopy of Skin—Constraints and Effective Novel Strategy in Multivariate Calibration

Biosensors ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 64
Author(s):  
H. Michael Heise ◽  
Sven Delbeck ◽  
Ralf Marbach
Keyword(s):  
Blood Glucose ◽  
Near Infrared ◽  
Multivariate Calibration ◽  
Response Spectrum ◽  
Blood Glucose Monitoring ◽  
Oral Glucose ◽  
Spectral Interval ◽  
Sample Population ◽  
Vibration Band ◽  
Absorption Bands

For many years, successful noninvasive blood glucose monitoring assays have been announced, among which near-infrared (NIR) spectroscopy of skin is a promising analytical method. Owing to the tiny absorption bands of the glucose buried among a dominating variable spectral background, multivariate calibration is required to achieve applicability for blood glucose self-monitoring. The most useful spectral range with important analyte fingerprint signatures is the NIR spectral interval containing combination and overtone vibration band regions. A strategy called science-based calibration (SBC) has been developed that relies on a priori information of the glucose signal (“response spectrum”) and the spectral noise, i.e., estimates of the variance of a sample population with negligible glucose dynamics. For the SBC method using transcutaneous reflection skin spectra, the response spectrum requires scaling due to the wavelength-dependent photon penetration depth, as obtained by Monte Carlo simulations of photon migration based on estimates of optical tissue constants. Results for tissue glucose concentrations are presented using lip NIR-spectra of a type-1 diabetic subject recorded under modified oral glucose tolerance test (OGTT) conditions. The results from the SBC method are extremely promising, as statistical calibrations show limitations under the conditions of ill-posed equation systems as experienced for tissue measurements. The temporal profile differences between the glucose concentration in blood and skin tissue were discussed in detail but needed to be further evaluated.

scholarly journals Dulaglutide exerts beneficial anti atherosclerotic effects in ApoE knockout mice with diabetes: the earlier, the better

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Junpei Sanada ◽  
Atsushi Obata ◽  
Yoshiyuki Obata ◽  
Yoshiro Fushimi ◽  
Masashi Shimoda ◽  
...  
Keyword(s):  
Early Intervention ◽  
Knockout Mice ◽  
Aortic Root ◽  
Late Phase ◽  
Intervention Group ◽  
Atherosclerotic Lesion ◽  
Expression Levels ◽  
Late Intervention ◽  
Apoe Knockout Mice ◽  
Early Intervention Group

AbstractThere has been no report about the mechanism for anti-atherosclerotic effects of dulaglutide (Dula) and/or about the difference of its effectiveness between in an early and a late phase of diabetes. To address such questions, streptozotocin (STZ) was intraperitoneally injected to ApoE knockout mice at 8 weeks of age. Either Dula or vehicle was administered to STZ-induced diabetic ApoE knockout mice from 10 to 18 weeks of age as an early intervention group and from 18 to 26 weeks as a late intervention group. Next, non-diabetic ApoE knockout mice without STZ injection were subcutaneously injected with either Dula or vehicle. In an early intervention group, atherosclerotic lesion in aortic arch and Mac-2 and CD68-positive areas in aortic root were significantly smaller in Dula group. In abdominal aorta, expression levels of some villain factors were lower in Dula group. In a late intervention group, there were no immunohistological differences in aortic root and expression levels of various factors between two groups. Furthermore, even in non-diabetic ApoE knockout mice, expression levels of inflammatory and macrophage markers were reduced by treatment with Dula. Taken together, Dula exerts more beneficial anti-atherosclerotic effects in an early phase of diabetes rather than in a late phase.

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