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Effects of vitamin D, omega-3 and a simple strength exercise programme in cardiovascular disease prevention: The DO-HEALTH randomized controlled trial.
Gaengler, S, Sadlon, A, De Godoi Rezende Costa Molino, C, Willett, WC, Manson, JE, Vellas, B, Steinhagen-Thiessen, E, Von Eckardstein, A, Ruschitzka, F, Rizzoli, R, et al
The journal of nutrition, health & aging. 2024;28(2):100037
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There is an increased risk of developing cardiovascular disease in older adults with an increase in metabolic markers such as lipid levels and blood pressure in old age. Previous studies have shown that non-pharmaceutical interventions such as supplementation with marine omega-3 fatty acids and vitamin D and increasing physical activity may help reduce these metabolic marker levels. This DO-HEALTH double-blinded, randomised, placebo-controlled trial investigated the benefits of marine omega-3 fatty acids, vitamin D3 and a strength training home exercise programme (SHEP) in reducing the lipid levels, hypertension, and other cardiovascular biomarkers and reducing the risk of major cardiovascular events in active older adults. The interventions included supplementation of vitamin D3 2000 IU/day, 1 g omega-3 PUFA of marine origin (330 mg EPA: 660 mg DHA) and 30 minutes of strength training for three days a week. The Do-Health study ran for three years and 2157 active older adults enrolled into the study. This trial showed that omega-3 fatty acid supplementation decreased triglycerides and increased High-density lipoprotein levels. Omega 3 supplementation also showed a non-significant reduction in low-density lipoproteins, non-HDL and total cholesterol in older active adults. The intervention strategies did not show any benefits on hypertension or prevention of major cardiovascular events. Further robust studies using different dosages of supplements and different study durations are required to determine the efficacy of omega-3 fatty acid and vitamin D3 supplementation and strength training in reducing metabolic and cardiovascular biomarkers. However, healthcare professionals can use the results of this trial to understand the benefits of omega-3 fatty acid supplementation in older active adults.
Abstract
BACKGROUND The effects of non-pharmaceutical interventions in the prevention of cardiovascular diseases (CVD) in older adults remains unclear. Therefore, the aim was to investigate the effect of 2000 IU/day of vitamin D3, omega-3 fatty acids (1 g/day), and a simple home strength exercise program (SHEP) (3×/week) on lipid and CVD biomarkers plasma changes over 3 years, incident hypertension and major cardiovascular events (MACE). METHODS The risk of MACE (coronary heart event or intervention, heart failure, stroke) was an exploratory endpoint of DO-HEALTH, incident hypertension and change in biomarkers were secondary endpoints. DO-HEALTH is a completed multicentre, randomised, placebo-controlled, 2 × 2 × 2 factorial design trial enrolling 2157 Europeans aged ≥70 years. RESULTS Participants' median age was 74 [72, 77] years, 61.7% were women, 82.5% were at least moderately physically active, and 40.7% had 25(OH)D < 20 ng/mL at baseline. Compared to their controls, omega-3 increased HDL-cholesterol (difference in change over 3 years: 0.08 mmol/L, 95% CI 0.05-0.10), decreased triglycerides (-0.08 mmol/L, (95%CI -0.12 to -0.03), but increased total- (0.15 mmol/L, 95%CI 0.09; 0.2), LDL- (0.11 mmol/L, 0.06; 0.16), and non-HDL-cholesterol (0.07 mmol/L, 95%CI 0.02; 0.12). However, neither omega-3 (adjustedHR 1.00, 95%CI 0.64-1.56), nor vitamin D3 (aHR 1.37, 95%CI 0.88-2.14), nor SHEP (aHR 1.18, 95%CI 0.76-1.84) reduced risk of MACE or incident hypertension compared to control. CONCLUSION Among generally healthy, active, and largely vitamin D replete, older adults, treatment with omega-3, vitamin D3, and/or SHEP had no benefit on MACE prevention. Only omega-3 supplementation changed lipid biomarkers, but with mixed effects. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER NCT01745263.
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Feasibility and preliminary efficacy of different intensities of functional training in elderly type 2 diabetes patients with cognitive impairment: a pilot randomised controlled trial.
Ghahfarrokhi, MM, Shirvani, H, Rahimi, M, Bazgir, B, Shamsadini, A, Sobhani, V
BMC geriatrics. 2024;24(1):71
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Aging is associated with an increased risk of metabolic diseases, including diabetes. The prevalence of type 2 diabetes (T2D) is directly related to increasing age. The aim of this study was to investigate the feasibility and preliminary effectiveness of six weeks of different intensities of functional exercises in elderly T2D patients with cognitive impairment. This study was a randomised controlled trial. Subjects were randomly assigned into high-intensity functional training (HIFT), low-intensity functional training (LIFT) and control groups. The subjects were allocated to a 2:2:2 ratio. Results showed that high-intensity low-volume vs. low-intensity high-volume functional training is a safe, feasible, and effective way to enhance aspects of physical, biochemical, and cognitive function in older T2D patients who have cognitive impairment. Additionally, HIFT can improve variables related to cognitive function in elderly T2D patients. Authors concluded that HIFT vs. LIFT is a safe, feasible, and effective approach for improving some aspects of physical, biochemical, and cognitive function in elderly T2D patients with cognitive impairment.
Abstract
BACKGROUND Aging and type-2 diabetes (T2D) are the most important risk factors for cognitive impairment and Alzheimer's disease. Exercise training is an effective, safe, and practical intervention in improving glucose metabolism, physical function, and cognitive disorders. This pilot study investigated the feasibility and preliminary efficacy of high-intensity low-volume (HIFT) vs. low-intensity high-volume (LIFT) functional training in elderly T2D patients with cognitive impairment. METHODS Forty-eight elderly T2D patients (31 female, 17 male, age 67.5 ± 5.8 years, MMSE score 18.8 ± 2.6, FBG 209.5 ± 37.9) were randomly assigned to HIFT, LIFT and control groups. Cognitive impairment was diagnosed with MMSE ≤ 23 based Iranian society. The SDMT, CVLT-II, BVMT-R, and Stroop tests were used to evaluated processing speed, learning, memory and attention respectively. Physical fitness tests include: tandem stance and walk test; TUG; 6MWT, 10MWT; SSST; 5TSTS; and hand grip was used to evaluated static and dynamic balance, agility, walking endurance, gait speed, lower limb function and lower and upper body strength respectively. As well as, Biochemical (FBG, insulin, HOMA-IR, HbA1c) and physiological outcomes (SBP, and DBP) were assessed. The HIFT group performed six weeks of functional training (three sessions per week) with 120-125% of the lactate threshold. The LIFT group performed six weeks of functional training (five sessions per week) with a 70-75% lactate threshold. Feasibility, safety, and acceptability of exercise programs were assessed at the end of the study. RESULT HIFT showed a higher adherence rate (91% vs. 87.5%), safety, and acceptability compared to LIFT. MMSE and Stroop scores, 6MWT, FBG, insulin, HOMA-IR, HbA1c, SBP, and DBP significantly improved in HIFT (all, P ≤ 0.004) and LIFT (all, P ≤ 0.023). Changes in 6MWT, FBG, insulin, HOMA-IR, and HbA1c in HIFT (all, P ≤ 0.001) and LIFT (all, P ≤ 0.008) were significant compared to the control group. Changes in Stroop scores were significant only in the HIFT group compared to the control group (P = 0.013). SDMT, CVLT-II, BVMT-R, balance test, 10MWT, SSST, TUG and hang grip significantly improved only in HIFT (all, P ≤ 0.038). CONCLUSION HIFT vs. LIFT is a safe, feasible, and effective approach for improving some aspects of physical, biochemical, and cognitive function in elderly T2D patients with cognitive impairment. This pilot study provides initial proof-of-concept data for the design and implementation of an appropriately powered randomised controlled trial (RCT) of HIFT vs. LIFT in a larger sample of elderly T2D patients with cognitive impairment. TRIAL REGISTRATION Randomized controlled trial (RCT) (Iranian Registry of Clinical Trials, trial registration number: IRCT20230502058055N1. Date of registration: 11/06/2023.
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Impact on diabetes control and patient-reported outcomes of a newer implantable continuous glucose monitoring system (Eversense® CGM System): a single-centre retro- and prospective observational study.
Dimitri Guy Rohner, Lukas Burget, Christoph Henzen, Stefan Fischli
Swiss medical weekly. 2024;154:3366
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To avoid and reduce diabetic complications and glucose fluctuations (hypo- and hyperglycaemia) people with diabetes mellitus type 1 depend on close monitoring of their glucose values. The Eversense® CGM System is the first and only continuous glucose monitoring system (CGMS) that uses a fully subcutaneous implanted sensor. The aim of this study was to evaluate the effectiveness, safety, and patient-reported outcomes in patients with type 1 diabetes mellitus using the Eversense®CGM System. This study was a prospective and retrospective study, conducted at a single Swiss diabetes centre (Luzerner Kantonsspital). It included patients who had at least one Eversense® glucose sensor implanted between 2017 and 2022. Results showed that: - HbA1c levels changed by –0.25% at 6 months, –0.45% at 12 months, and –0.2% at the last follow-up after sensor implantation. - Premature sensor breakdowns occurred in 9% of cases, mainly between 2019 and 2020. - Major complications were rare, except for one infection and four complicated removals. - Patient-reported outcomes showed positive impacts on hypoglycaemia rates, confidence in managing hypoglycaemia, and diabetes management. Authors concluded that The Eversense® CGM System demonstrated favourable effects on HbA1c levels and patient-reported outcomes, with low rates of complications. Technical issues were reported but were rare with the newest sensor generation.
Abstract
AIMS OF THE STUDY The Eversense® CGM System is the first and only continuous glucose monitoring system (CGMS) that uses a fully subcutaneous implanted sensor. This study aimed to evaluate effectiveness, safety and patient-reported outcomes in patients using the Eversense® CGM System in a realistic clinical setting, assessed at a single Swiss diabetes centre (Luzerner Kantonsspital) with prolonged follow-up. METHODS This was a prospective and retrospective observational study that included patients with type 1 diabetes mellitus in whom at least one Eversense® glucose sensor was implanted between 2017 and 2022. The primary endpoint was the change in HbA1c levels from the baseline (before implantation of the sensor) to 6 ± 2 and 12 ± 2 months and the last follow-up (newest available value) after implantation. The secondary outcome measures were the number of premature sensor breakdowns, adverse events related to the implantation procedure (infection, bleeding, difficulties with implantation or explantation) and patient-related outcomes (assessed with a questionnaire). RESULTS A total of 33 patients participated in this study. The median follow-up time was 50 (IQR 22.3-58.5) months. In total, 178 sensor implantations were performed. Valid HbA1c results were available for 26 participants. Compared to the baseline values, HbA1c levels at 6 and 12 months and the last follow-up changed by -0.25%, -0.45 and -0.2 (p = 0.278, 0.308 and 0.296, respectively). We recorded 16 (9%) premature sensor breakdowns, all occurring between 2019 and 2020. Apart from one late-onset infection and four complicated sensor removals, no major complications were assessed. The results of the questionnaire showed a subjective improvement in hypoglycaemia rates, a better perception of hypoglycaemia and the impression of better diabetes management. Common issues with the device reported by the patients were technical errors (connection problems) and problems with the removal procedure. CONCLUSIONS The use of the Eversense® CGM System resulted in changes in HbA1c of between -0.2% and -0.45%. The rate of premature sensor breakdown was low. Major complications following sensor implantation or removal were absent, apart from one case of infection and four cases of complicated removal. Patient-reported outcomes with the Eversense® CGM System showed a subjective positive impact on hypoglycaemia rates, greater confidence in managing hypoglycaemia and diabetes in general, and easy handling of the transmitter and mobile app. Technical issues must be considered but are nowadays, with the use of the newest sensor generation, very rare.
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Eating habits and sleep quality in individuals with type 1 diabetes on continuous glucose monitoring and insulin pump.
Corrado, A, Scidà, G, Vitale, M, Caprio, B, Costabile, G, Annuzzi, E, Della Pepa, G, Lupoli, R, Bozzetto, L
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2024;34(7):1703-1711
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Sleep disruption related to daily behaviours, routines, and environmental exposure to stressors, including dietary habits, and possible consequent sleep disorders (i.e. insomnia, sleep apnea, etc.) are bidirectionally linked with obesity and glucose metabolism abnormalities. The aim of this study was to investigate the relationship between dietary habits and sleep quality in individuals with type 1 diabetes, and how these factors may influence each other in the context of modern diabetes management technologies. This study was a cross-sectional study, which involved collecting data from a specific population at a single point in time. Results showed that individuals with type 1 diabetes who had poor sleep quality also tended to have less healthy eating habits, particularly at dinner time. This was independent of their post-dinner blood glucose control. Authors concluded that the study highlights a bidirectional link between sleep quality and eating habits in individuals with type 1 diabetes. Thus, improving sleep quality could potentially lead to healthier eating habits, thereby improving overall management of the condition.
Abstract
BACKGROUND AND AIMS Sleep disorders are bidirectionally linked with eating behaviors and glucose metabolism, which could be clinically relevant in type 1 diabetes (T1D). We investigated the relationship between dietary habits and sleep quality in individuals with T1D on insulin pumps and continuous glucose monitoring (CGM). METHODS AND RESULTS In a cross-sectional study, dietary habits (7-day food diary, EPIC questionnaire) and sleep quality (Pittsburgh Sleep Quality Index questionnaire) were assessed in 59 men and 58 women with T1D, aged 19-79 years, using CGM and insulin pump. Differences in dietary habits and blood glucose after dinner (6 h) between participants differing in sleep quality, sleep duration, and sleep onset latency were evaluated. Bad Sleepers (n = 81) were twice as prevalent as Good Sleepers (n = 36) and had a significantly higher intake of fat than Good Sleepers (dinner: 30.7 ± 10.7 vs. 24.0 ± 10.5 g, p = 0.004). Short sleepers had a significantly higher usual intake (g/1000 kcal) of coffee and tea (90.4 ± 71.7 vs. 62.0 ± 35.6), alcoholic (47.8 ± 51.1 vs. 28.9 ± 31.5) and carbonated beverages (21.8 ± 38.1 vs. 9.3 ± 17.2) (p < 0.05 for all) than Long Sleepers. Long Sleep Onset Latency was associated with a significantly higher fat intake at dinner (41.8 ± 7.4 vs. 38.1 ± 9.1 % total energy, p = 0.029) than Short Sleep Onset Latency. No significant differences in post-dinner blood glucose levels were detected between participants with good or bad sleep quality. CONCLUSION Sleep disruption is common in T1D and is associated with unhealthy dietary choices, especially at dinner, independently of post-dinner blood glucose control.
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Glycemic variability assessed using continuous glucose monitoring in individuals without diabetes and associations with cardiometabolic risk markers: A systematic review and meta-analysis.
Hjort, A, Iggman, D, Rosqvist, F
Clinical nutrition (Edinburgh, Scotland). 2024;43(4):915-925
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Chronic hyperglycaemia, assessed by HbA1c, is a risk factor for complications in individuals with diabetes. However, HbA1c does not reflect short-term fluctuations in blood glucose, which can vary a lot between individuals despite similar HbA1c. Glycaemic variability (GV) is a term used to describe such fluctuations, reflecting both hypoglycaemic events and postprandial spikes as well as fluctuations that are repeated at the same time on different days. The aim of this study was to assess whether GV is associated with cardiometabolic risk markers or outcomes in individuals without diabetes. Researchers examined data from continuous glucose monitoring studies. This study was a systematic review of 71 studies, primarily cross-sectional in design. Results showed that GV measures were higher in individuals with prediabetes compared to those without, potentially related to beta cell dysfunction. However, GV was not clearly associated with insulin sensitivity, adiposity, blood lipids, or blood pressure. Interestingly, GV may predict coronary atherosclerosis development and cardiovascular events, as well as type 2 diabetes. Authors concluded that although GV is elevated in prediabetes, its association with traditional risk factors remains less clear. Prospective studies are needed to explore GV’s predictive power in relation to incident disease.
Expert Review
Conflicts of interest:
None
Take Home Message:
Continuous glucose monitors are widely available. They could help nutritionists and nutritional therapists to personalise nutrition plans and reduce risk factors for cardiovascular disease and type 2 diabetes when working with a qualified health care practitioner.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
Glycaemic variability (GV) has been associated with increased risk of cardiovascular disease (CVD) in individuals with type 2 diabetes (T2D). It is not known whether there are similar risks for individuals without T2D. Continuous blood glucose monitors (CGM) measure short-term GV and may be a potential tool for assessing these risks.
Methods
- 71 worldwide studies with diverse populations were included in this systematic review and meta-analysis. Most studies were cross sectional and included CGM use for 24 hours or longer.
- Measurement data included: standard deviation (SD) and coefficient of variation (CV) of GV, mean amplitude of glycaemic excursions (MAGE), mean of daily differences (MODD), continuous overlapping net glycaemic action (CONGA), M-value, lability index (L-index), J-index or glycaemic risk assessment in diabetes equation (GRADE).
- Outcome measurements were any associated with cardiometabolic risk markers.
Results
- Adults with prediabetes had greater SD (p <0.0001), CV (p =0.008) and MAGE (p<0.0001) values. SD, MODD, and MAGE were also higher in individuals with normal glucose tolerance (NGT) and a previous history of gestational diabetes.
- SD was higher in children and adolescents with prediabetes. SD and CV were also higher in adolescents with cystic fibrosis. An inverse association was found in adolescents for MAGE and soluble receptor of advanced glycation end-products (sRAGE) (P=<0.05).
- 6 studies found measures of beta-cell function were inversely associated with GV.
- Higher levels of MAGE were positively associated with a higher incidence of cardiovascular events (p=0.004), higher C-reactive protein and PAI-1 (p<0.001).
- No differences were found in GV between obese, overweight and normal weight individuals, nor correlations with body composition for all populations (p>0.05 for all).
Conclusion
This study found that GV is elevated in adults with prediabetes compared to individuals with NGT and may be linked with beta-cell dysfunction. The evidence for children and adolescents was less clear. GV was also positively associated with the development of atherosclerosis and an increased risk of cardiovascular events. GV may therefore be an effective proxy for cardiovascular risk in adults without diabetes.
Clinical practice applications:
- There is a large variability in postprandial response between individuals consuming the same foods.
- HbA1C does not include short term variability in blood glucose levels.
- CGMs are widely available and easily accessible and could help nutritionists and nutritional therapists to provide personalised nutrition plans.
- This study found that changes in GV were not associated with HbA1c, fasting glucose, homeostatic model assessment of insulin resistance or oral glucose tolerance test-derived measures.
- GV was also not associated with adiposity, blood pressure, blood fatty liver disease, blood lipid profile or oxidative stress.
Considerations for future research:
- Limitations of this study were the inclusion of mainly cross-sectional data as well as the heterogeneity between outcome measures, study durations, populations and sample sizes.
- Further prospective studies are needed in healthy individuals.
- Future studies should focus on measurements that specifically assess GV and cardiometabolic risk markers.
Abstract
BACKGROUND & AIMS Continuous glucose monitoring (CGM) provides data on short-term glycemic variability (GV). GV is associated with adverse outcomes in individuals with diabetes. Whether GV is associated with cardiometabolic risk in individuals without diabetes is unclear. We systematically reviewed the literature to assess whether GV is associated with cardiometabolic risk markers or outcomes in individuals without diabetes. METHODS Searches were performed in PubMed/Medline, Embase and Cochrane from inception through April 2022. Two researchers were involved in study selection, data extraction and quality assessment. Studies evaluating GV using CGM for ≥24 h were included. Studies in populations with acute and/or critical illness were excluded. Both narrative synthesis and meta-analyzes were performed, depending on outcome. RESULTS Seventy-one studies were included; the majority were cross-sectional. Multiple measures of GV are higher in individuals with compared to without prediabetes and GV appears to be inversely associated with beta cell function. In contrast, GV is not clearly associated with insulin sensitivity, fatty liver disease, adiposity, blood lipids, blood pressure or oxidative stress. However, GV may be positively associated with the degree of atherosclerosis and cardiovascular events in individuals with coronary disease. CONCLUSION GV is elevated in prediabetes, potentially related to beta cell dysfunction, but less clearly associated with obesity or traditional risk factors. GV is associated with coronary atherosclerosis development and may predict cardiovascular events and type 2 diabetes. Prospective studies are warranted, investigating the predictive power of GV in relation to incident disease. GV may be an important risk measure also in individuals without diabetes.
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Continuous glucose monitoring in adults with type 2 diabetes: a systematic review and meta-analysis.
Jancev, M, Vissers, TACM, Visseren, FLJ, van Bon, AC, Serné, EH, DeVries, JH, de Valk, HW, van Sloten, TT
Diabetologia. 2024;67(5):798-810
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Continuous glucose monitoring (CGM) is increasingly used in the treatment of type 2 diabetes, but its effects on glycaemic control remain unclear. Fingerstick-based self-monitoring of blood glucose (SMBG) has been the most used method for measuring daily glucose levels. However, this method does not provide continuous data about glucose levels, and, thus, may miss asymptomatic hypo- or hyperglycaemia and does not provide information about the direction of change in glucose levels. The aim of this study was to give an up-to-date comprehensive overview of the effect of CGM (rtCGM or isCGM) comparison with SMBG on glycaemic control, as quantified by HbA1c, in adults with type 2 diabetes treated with or without insulin. This study was a systematic review and meta-analysis, analysing randomised controlled trials comparing real-time CGM or intermittently scanned CGM with SMBG in adults with type 2 diabetes. Results showed that: - CGM use (rtCGM or isCGM) led to a modest reduction in HbA1c (mean difference of −3.43 mmol/mol or −0.31%). - CGM also improved time in range and reduced time below range, time above range and glycaemic variability. Authors concluded that CGM shows promise in improving glycaemic control for adults with type 2 diabetes.
Abstract
AIMS/HYPOTHESIS Continuous glucose monitoring (CGM) is increasingly used in the treatment of type 2 diabetes, but the effects on glycaemic control are unclear. The aim of this systematic review and meta-analysis is to provide a comprehensive overview of the effect of CGM on glycaemic control in adults with type 2 diabetes. METHODS We performed a systematic review using Embase, MEDLINE, Web of Science, Scopus and ClinicalTrials.gov from inception until 2 May 2023. We included RCTs investigating real-time CGM (rtCGM) or intermittently scanned CGM (isCGM) compared with self-monitoring of blood glucose (SMBG) in adults with type 2 diabetes. Studies with an intervention duration <6 weeks or investigating professional CGM, a combination of CGM and additional glucose-lowering treatment strategies or GlucoWatch were not eligible. Change in HbA1c and the CGM metrics time in range (TIR), time below range (TBR), time above range (TAR) and glycaemic variability were extracted. We evaluated the risk of bias using the Cochrane risk-of-bias tool version 2. Data were synthesised by performing a meta-analysis. We also explored the effects of CGM on severe hypoglycaemia and micro- and macrovascular complications. RESULTS We found 12 RCTs comprising 1248 participants, with eight investigating rtCGM and four isCGM. Compared with SMBG, CGM use (rtCGM or isCGM) led to a mean difference (MD) in HbA1c of -3.43 mmol/mol (-0.31%; 95% CI -4.75, -2.11, p<0.00001, I2=15%; moderate certainty). This effect was comparable in studies that included individuals using insulin with or without oral agents (MD -3.27 mmol/mol [-0.30%]; 95% CI -6.22, -0.31, p=0.03, I2=55%), and individuals using oral agents only (MD -3.22 mmol/mol [-0.29%]; 95% CI -5.39, -1.05, p=0.004, I2=0%). Use of rtCGM showed a trend towards a larger effect (MD -3.95 mmol/mol [-0.36%]; 95% CI -5.46 to -2.44, p<0.00001, I2=0%) than use of isCGM (MD -1.79 mmol/mol [-0.16%]; 95% CI -5.28, 1.69, p=0.31, I2=64%). CGM was also associated with an increase in TIR (+6.36%; 95% CI +2.48, +10.24, p=0.001, I2=9%) and a decrease in TBR (-0.66%; 95% CI -1.21, -0.12, p=0.02, I2=45%), TAR (-5.86%; 95% CI -10.88, -0.84, p=0.02, I2=37%) and glycaemic variability (-1.47%; 95% CI -2.94, -0.01, p=0.05, I2=0%). Three studies reported one or more events of severe hypoglycaemia and macrovascular complications. In comparison with SMBG, CGM use led to a non-statistically significant difference in the incidence of severe hypoglycaemia (RR 0.66, 95% CI 0.15, 3.00, p=0.57, I2=0%) and macrovascular complications (RR 1.54, 95% CI 0.42, 5.72, p=0.52, I2=29%). No trials reported data on microvascular complications. CONCLUSIONS/INTERPRETATION CGM use compared with SMBG is associated with improvements in glycaemic control in adults with type 2 diabetes. However, all studies were open label. In addition, outcome data on incident severe hypoglycaemia and incident microvascular and macrovascular complications were scarce. REGISTRATION This systematic review was registered on PROSPERO (ID CRD42023418005).
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Continuous Glucose Monitoring-Based Metrics and Hypoglycemia Duration in Insulin-Experienced Individuals With Long-standing Type 2 Diabetes Switched From a Daily Basal Insulin to Once-Weekly Insulin Icodec: Post Hoc Analysis of ONWARDS 2 and ONWARDS 4.
Bajaj, HS, Ásbjörnsdóttir, B, Carstensen, L, Laugesen, C, Mathieu, C, Philis-Tsimikas, A, Battelino, T
Diabetes care. 2024;47(4):729-738
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This study’s aim was to assess CGM-based metrics and hypoglycaemia duration with once-weekly insulin icodec [a basal insulin analog in clinical development with a mean half-life of 1 week, allowing for once weekly dosing] versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials ONWARDS 2 (n=525) and ONWARDS 4 (n=582). This study was a post hoc analysis of data from ONWARDS 2 and ONWARDS 4. Results showed that: - in insulin-experienced participants with long-standing type 2 diabetes, compared with once-daily basal insulin analogs, switching from daily basal insulin to once-weekly icodec was associated with similar mean percentages of CGM-based time in range and time above range when assessed across three separate time periods in ONWARDS 2 and ONWARDS 4. - mean CGM based time below range remained within the recommended targets in both arms in both trials. - the duration of CGM-derived overall hypoglycaemic episodes (sensor glucose <3.9 mmol/L) was comparable for icodec versus once-daily basal insulins, with median duration of about 40 min. Authors concluded that their findings are relevant to clinical practice, where reduced injection burden and greater treatment satisfaction could contribute to improved adherence to basal insulin treatment.
Abstract
OBJECTIVE This post hoc analysis assessed continuous glucose monitoring (CGM)-based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4). RESEARCH DESIGN AND METHODS Time in range (TIR) (3.9-10.0 mmol/L), time above range (TAR) (>10.0 mmol/L), and time below range (TBR) (<3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0-4], end of treatment [weeks 22-26], and follow-up [weeks 27-31]) for icodec versus comparators (ONWARDS 2, insulin degludec [basal regimen]; ONWARDS 4, insulin glargine U100 [basal-bolus regimen]) using double-blind CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed. RESULTS In both trials, there were no statistically significant differences in TIR, TAR, or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the end-of-treatment period, mean TIR was 63.1% (icodec) vs. 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) vs. 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively) across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min). CONCLUSIONS In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods. TBR remained within recommended targets.
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Evaluation of Effects of Continuous Glucose Monitoring on Physical Activity Habits and Blood Lipid Levels in Persons With Type 1 Diabetes Managed With Multiple Daily Insulin Injections: An Analysis Based on the GOLD Randomized Trial (GOLD 8).
Nyström, T, Schwarz, E, Dahlqvist, S, Wijkman, M, Ekelund, M, Holmer, H, Bolinder, J, Hellman, J, Imberg, H, Hirsch, IB, et al
Journal of diabetes science and technology. 2024;18(1):89-98
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Type 1 diabetes is associated with increased risk of cardiovascular disease (CVD) and reduced life expectancy. Continuous glucose monitoring (CGM) has been shown to improve glycaemic control and well-being in patients with type 1 diabetes. This study’s aims were 1) to evaluate whether patients with type 1 diabetes using multiple daily insulin injections (MDI) exercise more after initiating CGM, and 2) to Investigate whether improved glycaemic control and well-being associated with CGM translate into improved blood lipid levels and markers of inflammation. This study was a randomised cross-over trial conducted over 16 months. Participants used either CGM or capillary self-monitoring of blood glucose (SMBG) for six months, with a four-month washout period between the two treatment periods. Results showed that: - physical activity levels did not change significantly during CGM or SMBG. - HbA1c levels differed significantly between SMBG and CGM treatment. - there weren’t any significant changes in low-density lipoprotein, high-density lipoprotein, triglycerides, total cholesterol, apolipoprotein A1, apolipoprotein B1, or high-sensitivity C-reactive protein levels during CGM and SMBG. Authors concluded that CGM did not influence the magnitude of physical activity. Risk markers of CVD such as blood lipids, apolipoprotein, and high-sensitivity C-reactive protein levels were similar during CGM and SMBG.
Abstract
BACKGROUND People with type 1 diabetes generally view it easier to exercise when having continuous information of the glucose levels. We evaluated whether patients with type 1 diabetes managed with multiple daily insulin injections (MDI) exercised more after initiating continuous glucose monitoring (CGM) and whether the improved glycemic control and well-being associated with CGM translates into improved blood lipids and markers of inflammation. METHOD The GOLD trial was a randomized cross-over trial over 16 months where patients used either CGM or capillary self-monitoring of blood glucose (SMBG) over six months, with a four-month wash-out period between the two treatment periods. We compared grade of physical activity, blood lipids, apolipoproteins, and high-sensitivity C-reactive protein (hsCRP) levels during CGM and SMBG. RESULTS There were 116 patients with information of physical activity estimated by the International Physical Activity Questionnaire (IPAQ) during both CGM and SMBG. No changes were found during CGM or SMBG, IPAQ scores 3305 versus 3878 (P = .16). In 136 participants with information of blood lipid levels with no change in lipid-lowering medication during the two treatment periods, HbA1c differed by 4.2 mmol/mol (NGSP 0.39%) between SMBG and CGM treatment (P < .001). No significant changes existed in low-density lipoprotein, high-density lipoprotein, triglycerides, total cholesterol, apolipoprotein A1, apolipoprotein B1, or hsCRP, during CGM and SMBG. CONCLUSION Although many patients experience it easier to perform physical activity when monitoring glucose levels with CGM, it does not influence the amount of physical activity in persons with type 1 diabetes. Blood lipids, apolipoprotein, and hsCRP levels were similar during CGM and SMBG.
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Continuous Glucose Monitoring Feedback in the Subsequent Development of Gestational Diabetes: A Pilot, Randomized, Controlled Trial in Pregnant Women.
Quah, PL, Tan, LK, Lek, N, Tagore, S, Chern, BSM, Ang, SB, Wright, A, Thain, SPT, Tan, KH
American journal of perinatology. 2024;41(S 01):e3374-e3382
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Pregnant women diagnosed with gestational diabetes mellitus (GDM) were shown to have higher glycemic variability which refers to fluctuations in blood glucose, compared to non-GDM women. This study's aim was to examine the effects of receiving glucose feedback from continuous glucose monitoring (CGM) by intermittent scanning (unblinded group) versus masked feedback (blinded group) in the subsequent development of GDM. This study was a prospective randomised controlled trial which enrolled 206 pregnant women who were in their first trimester of pregnancy. Participants were randomly divided into two groups in a 1:1 ratio. Results showed: - no significant differences in GDM outcomes or plasma glucose concentrations between study arms. - that the unblinded group had higher percentage time-in-range during pregnancy compared to the blinded group. - that CGM feedback, coupled with better glycaemic control, indicates its potential use for promoting better glucose control during pregnancy. Authors conclude that CGM feedback may enhance glucose management in pregnant women, but further research is needed to validate these findings.
Abstract
OBJECTIVE This study evaluated the effects of receiving glucose feedback from continuous glucose monitoring (CGM) by intermittent scanning (unblinded group), and CGM with masked feedback (blinded group) in the subsequent development of gestational diabetes mellitus (GDM). STUDY DESIGN This was a prospective, single-center, pilot, randomized controlled trial including n = 206 pregnant women in the first trimester of pregnancy with no prior diagnosis of type 1 or type 2 diabetes. The participants were randomized into the unblinded group or blinded group and wore the CGM in the first trimester of pregnancy (9-13 weeks), the second trimester of pregnancy (18-23 weeks), and late-second to early-third trimester (24-31 weeks). The primary outcome was GDM rate as diagnosed by the 75-g oral glucose tolerance test (OGTT) at 24 to 28 weeks. RESULTS Over 47 months, 206 pregnant women were enrolled at 9 to 13 weeks. The unblinded group had a higher prevalence of women who developed GDM (21.5 vs. 14.9%; p > 0.05), compared to the blinded group. In the unblinded group compared to the blinded group, plasma glucose values were higher at 1 hour (median 7.7 [interquartile range {IQR}: 6.3-9.2] vs. 7.5 [6.3-8.7]) and 2 hours (6.3 [5.8-7.7] vs. 6.2 [5.3-7.2]), but lower at 0 hour (4.2 [4.0-4.5] vs. 4.3 [4.1-4.6]; p > 0.05). All these differences were not statistically significant. CONCLUSION Glucose feedback from CGM wear in the first to the third trimester of pregnancy without personalized patient education failed to alter GDM rate. KEY POINTS · Continuous glucose monitoring (CGM) is feasible for use in pregnant women.. · No significant difference in gestational diabetes rates with or without CGM feedback.. · Future clinical trials should incorporate CGM education and personalized guidance to enhance study outcomes..
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Oral magnesium supplementation does not affect insulin sensitivity in people with insulin-treated type 2 diabetes and a low serum magnesium: a randomised controlled trial.
Drenthen, LCA, de Baaij, JHF, Rodwell, L, van Herwaarden, AE, Tack, CJ, de Galan, BE
Diabetologia. 2024;67(1):52-61
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Low serum magnesium has been implicated in the pathogenesis of type 2 diabetes and its cardiovascular complications. However, whether magnesium supplementation improves insulin sensitivity in individuals with type 2 diabetes and low serum magnesium levels remains uncertain. This study’s aim was to examine the effect of magnesium supplementation on insulin resistance using the euglycemic [target glucose concentration of 5.5 mmol/l for 120 min] clamp technique. This study was a randomised, double-blind, placebo-controlled, two-period, crossover intervention study. The enrolled participants had insulin-treated type 2 diabetes, were aged ≥18 years, had a body mass index of 18–40 kg/m², and a serum magnesium level ≤0.79 mmol/l. Oral magnesium supplementation (15 mmol/day) was compared to a matched placebo over 6 weeks. Results showed that magnesium supplementation increased serum magnesium levels but did not improve insulin sensitivity. Furthermore, glucose control, insulin need, blood pressure, lipid profile, and hypomagnesaemia-related symptoms remained similar between the magnesium and placebo groups. Authors concluded that their findings do not support routine use of magnesium supplementation in people with insulin-treated type 2 diabetes.
Abstract
AIMS/HYPOTHESIS Hypomagnesaemia has been associated with insulin resistance and an increased risk of type 2 diabetes. Whether magnesium supplementation improves insulin sensitivity in people with type 2 diabetes and a low serum magnesium level is unknown. METHODS Using a randomised, double-blind (both participants and investigators were blinded to the participants' treatment sequences), placebo-controlled, crossover study design, we compared the effect of oral magnesium supplementation (15 mmol/day) for 6 weeks with that of matched placebo in individuals with insulin-treated type 2 diabetes (age ≥18 years, BMI 18-40 kg/m2, HbA1c <100 mmol/mol [11.3%], serum magnesium ≤0.79 mmol/l). Participants were recruited from the outpatient clinic and through advertisements. Randomisation to a treatment sequence order was done using a randomisation list. We used block randomisation and the two possible treatment sequences were evenly distributed among the trial population. The primary outcome was the mean glucose infusion rate during the final 30 min of a hyperinsulinaemic-euglycaemic clamp (i.e. M value). Secondary outcomes included variables of glucose control, insulin need, BP, lipid profile and hypomagnesaemia-related symptoms during follow-up. RESULTS We recruited 14 participants (50% women, 100% White, mean ± SD age 67±6 years, BMI 31±5 kg/m2, HbA1c 58±9 mmol/mol [7.4±0.9%]) with insulin-treated type 2 diabetes. Magnesium supplementation increased both mean ± SEM serum magnesium level (0.75±0.02 vs 0.70±0.02 mmol/l, p=0.016) and urinary magnesium excretion (magnesium/creatinine ratio, 0.23±0.02 vs 0.15±0.02, p=0.005), as compared with placebo. The M value of the glucose clamp did not differ between the magnesium and placebo study arms (4.6±0.5 vs 4.4±0.6 mg kg-1 min-1, p=0.108). During the 6 weeks of treatment, continuous glucose monitoring outcomes, HbA1c, insulin dose, lipid profile and BP also did not differ, except for a lower HDL-cholesterol concentration after magnesium compared with placebo (1.14±0.08 vs 1.20±0.09 mmol/l, p=0.026). Symptoms potentially related to hypomagnesaemia were similar for both treatment arms. CONCLUSIONS/INTERPRETATION Despite an albeit modest increase in serum magnesium concentration, oral magnesium supplementation does not improve insulin sensitivity in people with insulin-treated type 2 diabetes and low magnesium levels. TRIAL REGISTRATION EudraCT number 2021-001243-27. FUNDING This study was supported by a grant from the Dutch Diabetes Research Foundation (2017-81-014).