Improvement In HbA1c Research Articles

The Impact of Medical Nutritional Therapy on the Efficacy of Premix Insulin in Glycemic Control in Patients with Type 2 Diabetes.

Medical nutritional therapy (MNT) is a key component in the treatment of Diabetes mellitus (DM). MNT is completely individual and should be present in the treatment of diabetes from the very beginning, continuously with pharmacological therapy, taking into account lifestyle, dietary habits and the type of antidiabetic therapy. Mistakes that are made when planning the diet are the absence of individual adjustment of the diet, which means that the number and time of meals, as well as the amount of UH per meal, is not adjusted to the patients' oral or insulin therapy according to their pharmacokinetics and pharmacodynamics. This study investigated the effect of MNT with reduced carbohydrate content (MNT M-ADA) on the efficacy of human and analogue premix insulin in patients with T2DM. Subjects were randomized into two groups (human and analog premix insulins), and then each group into two subgroups of 30 subjects each. One subgroup each on therapy with human and analog biphasic insulins was educated about MNT and learned to count UH, and then they applied MNT M-ADA for 24 weeks, unlike the other two subgroups. In this review, we present only the subgroup analysis on human and analog premix insulins that applied MNT M-ADA (200 g UH/day). Efficacy outcomes in the analysis of these subgroups were estimated changes in each subgroup from baseline to end point (week 24) and differences between subgroups at the end of the study in levels of glycated hemoglobin (HbA1c), self-measured glucose values (SMBG) and frequency of hypoglycemia. Both subgroups of subjects with MNT M-ADA improved glycemic control, which was assessed by improvements in HBA1C, SMBG levels, without an increase in the frequency of hypoglycemia, but at the end of the study there was no statistically significant difference in the mentioned parameters between the subgroups. The effectiveness of MNT M-ADA in people with T2DM did not depend on the type of insulin, both insulin regimens are effective if the amount of ingested UH is taken into account.

Cost-Effectiveness Analysis of the Culturally Developed Diabetes Self-Management Education and Support Program among Type 2 Diabetes Mellitus Patients in Iraq.

Diabetes mellitus (DM) is a chronic disease associated with a major economic burden on persons, health care systems, and countries. Diabetes self-management education and support (DSME(S)) programs are highly effective method in the management of T2DM patients. Therefore, this study aimed to determine the cost-effectiveness of the developed culturally-specific DSME(S) program regarding glycemic control, lipid profile, and body weight for Iraqi type 2 DM patients. A randomized controlled clinical trial design was used to assess the cost-effectiveness of the culturally-specific DSME(S) program from the perspective of health care providers. In the cost-effectiveness analysis (CEA), cost per patient and clinical outcomes over 6 months were compared between the intervention and control group. Incremental cost-effectiveness ratios (ICERs) were expressed as cost per unit improvement in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high density lipoprotein- cholesterol (HDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), and body weight. The effectiveness of most outcomes was better in the intervention group compared with the control group. The ICER per unit improvement in HbA1c, SBP, DBP, serum TC, and TG levels was <1 of the minimum CET compared with the control group, thus meeting the definition of being highly cost-effective. The currently developed DSME(S) was cost effective method to improve glycemic control, blood pressure, TC, and TG for T2DM patients in Iraq.

The METRO study: a retrospective analysis of the efficacy of metformin for type 2 diabetes in Japan.

Metformin monotherapy as first-line treatment for patients with type 2 diabetes (T2D) has been shown to effectively improve blood glucose levels and motivation to undergo treatment and prevent complications. However, no studies have reported its effect when combined with other drugs or compared the effect based on administration time. This study aimed to investigate the effect of metformin administration in Japanese patients with T2D, examine how the introduction line impacts the effect of metformin, and examine the characteristics of patients demonstrating improved blood glucose levels. Data on characteristics of patients who were newly prescribed metformin with no shifting of hypoglycemic agents in the subsequent 24-week observation period, and their age [mean, 56.8 years], body mass index [mean, 27.5 kg/m2], glycated hemoglobin [HbA1c] [mean, 8.1%], and duration of diabetes [mean, 3.0 years] were obtained from the medical records of 201 patients. The changes in HbA1c by introduction line after 24 weeks were -1.59%, -0.91%, -0.89%, and -0.65% in the first, second, third, and fourth induction lines, respectively; earlier introduction more significantly improved blood glucose. The factors significantly associated with HbA1c changes were early introduction, high baseline HbA1c, high estimated glomerular filtration rate, decreased insulin secretion, short estimated duration of diabetes, and increased metformin dose. Furthermore, factors contributing to the largest HbA1c improvement by metformin were high baseline HbA1c and early administration. Metformin is expected to lower blood glucose levels in Japanese patients with T2D, even in those with decreased insulin secretion, due to its early introduction as a first-line drug.

Gut adaptation after gastric bypass in humans reveals metabolically significant shift in fuel metabolism.

Roux-en-Y gastric bypass surgery (RYGB) is among the most effective therapies for obesity and type 2 diabetes, and intestinal adaptation is a proposed mechanism for these effects. It was hypothesized that intestinal adaptation precedes and relates to metabolic improvement in humans after RYGB. This was a prospective, longitudinal, first-in-human study of gene expression (GE) in the "Roux limb" (RL) collected surgically/endoscopically from 19 patients with and without diabetes. GE was determined by microarray across six postoperative months, including at an early postoperative (1month ± 15 days) time point. RL GE demonstrated tissue remodeling and metabolic reprogramming, including increased glucose and amino acid use. RL GE signatures were established early, before maximal clinical response, and persisted. Distinct GE fingerprints predicted concurrent and future improvements in HbA1c and in weight. Human RL exhibited GE changes characterized by anabolic growth and shift in metabolic substrate use. Paradoxically, anabolic growth in RL appeared to contribute to the catabolic state elicited by RYGB. These data support a role for a direct effect of intestinal energy metabolism to contribute to the beneficial clinical effects of RYGB, suggesting that related pathways might be potential targets of therapeutic interest for patients with obesity with or without type 2 diabetes.

Metabolic control and satisfaction in a diabetes education programme in flash glucose monitoring through telemedicine in type 1 diabetes

ObjectiveTo evaluate metabolic control and satisfaction with a telemedicine diabetes education programme for the initiation of flash glucose monitoring (FGM) in type 1 diabetes. Material and methodsProspective study in 48 patients (52.1% women, 22.9% on insulin pump) who started FGM. They were analysed at baseline and 3 months after the beginning of the FGM. The results were compared with an on-site learning cohort matched by age, sex and HbA1c. ResultsAt the beginning and 3 months after the MFG, HbA1c improvement was observed (7.9±1.4 vs 7.3±1.1%), p<0.01; with a decrease in time below range - TBR - (4.7±4.9 vs 3.5±3.5%), p<0.05 and number of hypoglycaemic events (9.4±8.7 vs 6.9±5.7/15 days), p<0.05, associated with a worsening in time above range - TAR - (33.5±19.9 vs 37.0±20.9%), p<0.05. No significant differences were observed in the TIR 70–180mg/dl (61.7±18.6 vs 59.4±20.0%), glycemic variability or the use of FGM. Patient satisfaction with telemedicine training was 4.8±0.3 out of 5.No significant differences were observed in the follow-up, either in HbA1c or other glucometer parameters between on-site and online training.In a multivariate analysis adopting the HbA1c at follow-up as the dependent variable, only the TIR (β=−0.034; p<0.001) and the initial HbA1c (β=0.303; p<0.001) maintained statistical significance, unrelated to the on-site or online training (β=0.136; p=ns). ConclusionsA telemedicine programme is an adequate tool for training in FGM, with results similar to on-site training, and it was associated with a high degree of satisfaction.

Beneficial effects of adding magnesium to desalinated drinking water on metabolic and insulin resistance parameters among patients with type 2 diabetes mellitus: a randomized controlled clinical trial

There is evidence that increasing the consumption of water containing magnesium can improve glucose metabolism and insulin resistance in patients with type 2 diabetes mellitus (T2DM). This trial was undertaken with the objective of evaluating the effect of adding different concentrations of magnesium chloride to the desalinated drinking water on the glycemic, metabolic, and insulin resistance parameters among patients with T2DM. A randomized cross-sectional controlled clinical trial was conducted to evaluate the effects of adding magnesium chloride supplement to desalinated drinking water consumed by patients with T2DM on the glycemic and metabolic parameters and indicators of insulin sensitivity. The total number of patients with T2DM who successfully completed the trial is 102. Patients were randomly allocated into three groups: the first group received bottled water without added magnesium (0 mg/L) (Group A, n = 37); the second group received bottled water with a low level of magnesium (20 mg/L) (Group B, n = 33); and the third group received drinking water with a high level of magnesium (50 mg/L) (Group C, n = 32). The daily consumption of elemental magnesium for a period of 3 months resulted in significant improvement in HbA1C (8.0 vs 8.2%, p = 0.04), insulin level (7.5 vs 9.9 μIU/mL, p = 0.03), and homeostasis model assessment-estimated insulin resistance (HOMA.IR) (2.5 vs 2.9, p = 0.002) in group C. However, there was no significant improvement in fasting blood glucose (FBS) level or lipid profile. The results of this study suggest that oral magnesium supplementation at the given dose of 50 mg/L daily added to drinking water could improve long-term glycemic control indicators and reduce insulin resistance in patients with T2DM.

ODP171 Choosing GLP-1RA Over Insulin for Patients with Type 2 Diabetes and Severe Hyperglycemia

Abstract Introduction Although insulin remains the recommended treatment in type 2 diabetes for hyperglycemia with catabolic symptoms, it is also the generally recommended treatment for persistent hyperglycemia or hemoglobin A1c (HbA1c) values above 10% 1 . Recent data has suggested that glucagon like peptide 1 receptor agonists (GLP-1RAs) are also powerful at glucose lowering while additionally offering extra-glycemic benefits such as weight loss with minimal risk of hypoglycemia. Unfortunately, data on initial use of GLP-1RA is limited in patients with very high hemoglobin A1cs. Our objective was to evaluate outcomes in patients with type 2 diabetes and a baseline HbA1c of 10% or greater treated with GLP-1RAs instead of insulin. Methods This study is a small retrospective case series of insulin-naïve patients with uncontrolled type 2 diabetes who were prescribed an injectable GLP-1RA. Patients included had a baseline hemoglobin A1c ≥ 10% without signs of catabolism (weight loss, ketosis, significant polyuria), a minimum of one follow-up visit after initiating GLP-1RA, and at least one HbA1c measurement within six months of initiating treatment. Patients were excluded if they had previously been on insulin or a GLP-1RA in the past 1 year. The primary endpoint was change in HbA1c after 3-6 months of GLP-1 RA use. Results Of the patients initially screened, 7 patients fulfilled criteria and were included in the final analysis. The age range was 45-73 with 4 female patients and 3 male patients. The number of years patients had been diagnosed with type 2 diabetes ranged from 0 to 13 with 1 patient having newly diagnosed diabetes not previously on medications. Of the 6 patients who were on medical treatment at baseline, 3 patients were on monotherapy with either metformin or a sulfonylurea and 3 patients were on 2-4 oral hypoglycemic agents. Patients were continued on their initial medication regimen with the exception of DPP-4 inhibitors which were stopped at the time of GLP-1RA initiation. Mean baseline HbA1c prior to initiation of GLP-1RA was 11.9%. Following 3-6 months of GLP-1RA use, mean HbA1c significantly improved to 7.5% (p value= 0. 0005). All patients showed improvement of HbA1c in response to GLP-1RA initiation (mean HbA1c reduction = 4.4, minimum = 1.9, maximum = 7.5). All patients remained on GLP-1RA without significant side effects. Conclusion In this limited case series of patients with HbA1c ≥ 10%, GLP-1RAs were well tolerated and resulted in significant improvement in HbA1c. Our results suggest that GLP-1RAs should be considered as an alternative treatment option to insulin in non-catabolic patients with very high hemoglobin A1cs.

PSUN196 Outcomes following SGLT-2 inhibitor use in 99 patients with type 1 diabetes: A single-centre, retrospective, chart-review study

Abstract Introduction Despite the numerous benefits seen with the use of SGLT-2 inhibitors in patients with T1DM, the drug class has failed approval for this indication in both the US and Australia, largely due to the increased risk of ketosis and DKA. Resultantly there is limited real-world data for its use in this patient population. Methods We completed a retrospective medical record review of 99 patients with T1DM treated with an SGLT-2 inhibitor within a single outpatient clinic between 2014 to 2021. Our primary objective was to review the change in Hba1c and weight, as well as incidence of DKA, with secondary objectives to review the reduction in insulin dose, and reasons for cessation. Results Baseline characteristics demonstrated a female predominant population (63%) with a median BMI of 30kg/m2. Around half of our patients were on concurrent CSII therapy (53%) We observed an improvement in Hba1c in 72% of our patients, with a median decrease of 0.3% (P=0.001). 80% of patients noted a decrease in weight, with a median reduction of 4.2kg (P=0.10). Five patients developed DKA requiring hospitalisation, and the most common cause for SGLT-2i cessation was genital tract infection. The insulin requirement was noted to decrease by an median of 6.6 units (P=0.04). Conclusion SGLT-2 inhibitor class medications have a valuable role in the treatment of certain patients with T1DM. Our study is one of only a handful of real-life data sets, and unique in the number of patients involved. Future areas for review involve evaluating the effect of risk mitigation measures on the incidence of DKA. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

ODP181 Diabetes Mellitus and Advanced Liver Fibrosis – is Cirrhosis Reversible and Who Should We Screen?

Abstract Recent evidence shows an association between type 2 diabetes mellitus (T2DM) and liver steatosis, fibrosis, and hepatocellular carcinoma. Studies suggest that improved glycemic control, weight loss, and GLP-1 agonists may halt progression and even improve non-alcoholic fatty liver disease (NAFLD); however, little is known about the extent of improvement these factors have on liver fibrosis. ADA guidelines suggest only patients with T2DM or pre-DM and elevated liver enzymes (or fatty liver on ultrasound) should be evaluated for NAFLD and fibrosis. Three patients ages 65-71 with long-standing T2DM, HLD, obesity, and no history of liver disease or current alcohol use were followed in our diabetic clinic and referred for screening for liver steatosis and fibrosis. The transient elastography method (fibroscan) was used to determine the degree of liver fibrosis. On initial fibroscans, all three patients were found to have F4 scores consistent with liver cirrhosis. The first patient is a 71-year-old male with T2DM (BMI 37.5kg/m 2), treated with semaglutide, empagliflozin, glipizide, and insulin. Over two years, he experienced a 4-lb weight loss and improvement in HbA1c(7.8% to 7.1%). Repeat fibroscan after two years showed improved fibrosis score – F3 (11.6 kPa to 10.2 kPa), consistent with moderate fibrosis. The second patient is a 69-year-old female with T2DM (BMI 37.3kg/m 2) and transient mild LFT abnormalities, found to have cirrhosis on fibroscan – F4 score. She was managed with semaglutide, empagliflozin, metformin, and insulin; weight decreased 9-lbs over two years and HbA1c improved(10.8% to 7.8%). Repeat fibroscan showed improvement in fibrosis score to F2 (15.1 kPa to 8.9 kPa), and her LFT abnormalities resolved. The third patient is a 65-year-old male with T2DM (BMI 35kg/m 2). His initial fibroscan showed cirrhotic liver – F4 score. He was maintained on empagliflozin and dulaglutide- then switched to semaglutide. He experienced a 10-lb weight loss during this time and had a stable HbA1c(6.6%). Repeat fibroscan after one year showed improvement to F0-F1(11.3 kPa to 6.1 kPa) consistent with little to no liver scarring. These cases highlight two important factors: 1) ADA liver screening guidelines should be expanded to include obesity and dyslipidemia; and 2) advanced liver fibrosis in patients with diabetes is, to some degree, reversible. Not all of the patients initially met standard ADA screening criteria, mostly without elevated liver enzymes and no prior abnormal liver imaging. Yet, all were diabetic and obese with dyslipidemia, which are independent risk factors for NAFLD. Additionally, patients with improved glycemic control on GLP-1 treatment as well as some weight loss have promising results on repeat fibroscan. These findings may improve screening and management of diabetes-related liver disease. Further studies are needed to investigate to what extent GLP-1 agonists alone or in combination with glycemic control and weight loss contribute to these improvements. Presentation: No date and time listed

LBSUN307 A Randomized Controlled Pilot Study Of The Food Order Behavioral Intervention In Prediabetes

Abstract Background and Objectives Ordering the ingestion of carbohydrate-rich foods after protein/vegetables (carbohydrate-last food order) significantly reduced postprandial glucose and insulin excursions over 180 min in patients with prediabetes and type 2 diabetes, compared with the reverse food order (carbohydrate-first) in previous research. We implemented a 16-week food order behavioral intervention, assessing its feasibility and impacts on glucose tolerance (GT), HbA1c, and weight (wt) in adults with prediabetes. Methods Participants with overweight/obesity and prediabetes (HbA1c 5.7-6.4%) were randomized to receive either standard nutritional counseling (control group) or standard nutritional counseling plus carbohydrate-last food order counseling (FO group). Participants were instructed to maintain their usual level of exercise throughout the study; this was assessed by the Godin Leisure-Time Exercise questionnaire at baseline and wk 16. Participants in both groups received 4 in-person brief counseling sessions at 1-month intervals. Due to the Covid-19 pandemic, later participants received some or all of their counseling via telemedicine. Oral GT was tested at baseline and week 16. Feasibility was assessed via a questionnaire. Results Of the 45 randomized subjects, 39 completed the study (control 21, FO 18). Demographics and baseline variables including wt (190.8 lbs vs 191.1 lbs) and HbA1c (6% vs 6%) were similar between groups. Exercise levels did not differ between groups at baseline and wk 16. Within FO group, body wt declined (-3.6 ±5.7 lbs, p=0. 017; -1.8% ±2.8, p=0. 012), and there was a trend towards improvement in HbA1c (-0.1 ±0.2, p=0. 054). Control group wt changed (-2.6 ±6.8 lbs, p=0.102; -1.6% ±3.5, p=0. 048) without altering HbA1c (-0. 03 ±0.3, p=0.605). Changes in wt, HbA1c, and GT were not significantly different between groups. At week 16, 17 FO group subjects (94%) reported high intervention adherence, 13 (74%) reported it was easy to eat protein/vegetables before carbohydrates, and 14 (78%) reported they would continue eating protein/vegetables before carbohydrates. Conclusions Carbohydrate-last food order is a feasible behavioral strategy in individuals with prediabetes. More research with a larger sample size and longer duration is needed to delineate its clinical impact. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

OR03-3 Impact of Continuous Glucose Monitoring (CGM) on Lifestyle Modifications in Individuals with Prediabetes

Abstract Introduction Adherence to lifestyle modifications can prevent diabetes; however, this poses a challenge for most individuals. CGM is an effective tool for glycemic control and lifestyle modifications in patients with diabetes on insulin therapy. We explored the impact of CGM use in individuals with prediabetes. Hypothesis Individuals using CGM in addition to diabetes education will show improved adherence to lifestyle modifications and greater reduction of HbA1c as compared to those receiving diabetes education alone.Design57 individuals with prediabetes were randomized to use CGM for 3 months along with diabetes education (CGM group) or receive diabetes education alone (EDU group). Food frequency (UKDDQ) and physical activity (IPAQ) questionnaires were completed by participants at the beginning and at the end of the study (6 months). Primary outcomes were lifestyle modifications and changes in HbA1c. Secondary outcomes were changes in weight and blood pressure. Results Both groups reported an increase in healthy food choices; however, EDU group performed better (EDU: 12.4 vs 9.2, p&amp;lt;0.01, CGM: 10.6 vs 9.5, p 0.08). Unhealthy food choices were reduced in both groups. CGM group reported a greater increase in moderate physical activity levels (CGM: 230 vs 61 minutes/week, p 0.01, EDU: 78.5 vs 48 minutes/week, p 0.22). Vigorous physical activity was reported by more individuals in CGM group than EDU (35% vs 4%). Greater reduction in mean HbA1c was noted in CGM group (5.7 vs 5.9%, p 0.05) compared to EDU (5.8 vs 5.9%, p 0.01). 33% of participants in both groups had normalization of HbA1c at the end of study. CGM group had greater reduction in weight (3.5 vs 0.8 lb, p 0.1) and systolic BP (12 vs 2.4 mmHg, p 0.01) than EDU. Irrespective of group assignment, the study population had improvement in all outcomes despite the beginning of COVID-19 pandemic during 4th month of the study. Smaller number of participants in the CGM group reported negative impact of the pandemic on their lifestyle modifications than EDU (Diet: 68% vs 80%, Physical activity: 48% vs 64%). Majority of CGM group participants were able to maintain lifestyle changes after discontinuing CGM use (Diet: 72%, Physical activity: 84%). On comparing both interventions, 56% of CGM group participants felt CGM to be more helpful than education for lifestyle modifications, while 40% felt both interventions helped equally. Conclusions CGM use in addition to diabetes education resulted in improvement in physical activity, food choices, HbA1c, weight, and BP in individuals with prediabetes. The significance of diabetes education was noted by greater improvement in food choices in EDU group. CGM can be an effective tool for diabetes prevention with lifestyle modifications in prediabetes. The long-term impact of CGM use and cost-benefit analysis in high-risk patients needs to be explored further. Presentation: Saturday, June 11, 2022 12:00 p.m. - 12:15 p.m.

LBSUN213 An Investigation Into The Effects Of Dapagliflozin On Ketogenesis In Type 1 Diabetes

Abstract Background Treatment with sodium-glucose transporter (SGLT)-2 inhibitors in patients with type 1 diabetes (T1DM) is associated with increased ketogenesis and diabetic ketoacidosis (DKA). The exact relationship between SGLT-2 inhibitors use in T1DM and ketogenesis is not fully understood. Patients and Methods In this single center, randomized, double blind and placebo-controlled trial 70 patients with established T1DM were randomized into placebo, dapagliflozin (SGLT-2 inhibitor) alone, exenatide/Bydureon (short and long-term acting GLP-1 RA, respectively) alone or with dapagliflozin and exenatide/Bydureon (triple therapy) groups in addition to routine insulin treatment (titrated in all groups to reduce risk of hypoglycemia). Patients were tested acutely (single dose before and after 12 weeks of treatment) under extended fasting and insulinopenic conditions (stress conditions) and under basal fasting conditions during 12 weeks treatment period. Results At end of 12 weeks treatment, glycemic indices improved significantly compared to baseline in the dapagliflozin and Bydureon alone groups and improved significantly compared to placebo in the triple therapy group (HbA1c: -0.9±0.1%, p&amp;lt;0. 001). Weight loss was significant (p&amp;lt;0. 001) in all active treatment groups. Ketones (beta-hydroxybutyrate, BHB) increased significantly in blood (0.21±0. 04 to 1.57±0.21 mM) and urine under acute stress conditions in control group at baseline and at 12 weeks visits. The magnitude of this increase was reduced following a single dose of dapagliflozin or exenatide at baseline visit (average of 1.16±0.17 mM) but was further increased following a single dose in the dapagliflozin receiving groups at 12 weeks visit (average of 1.83±0.28 mM). Under acute testing conditions, single dose of dapagliflozin treatment was associated with reduced urinary BHB clearance at baseline and 12 weeks visits. After 12 weeks of treatment and under basal conditions, ketone levels in blood and urine were not significantly altered following dapagliflozin or Bydureon alone but were significantly higher in the triple therapy group (0.22±0. 04 to 0.42±0. 07 mM in blood). At 12 weeks of treatment, dapagliflozin was associated with increased glucagon and lipolysis (increased FFAs) while Bydureon was associated with decreased glucagon and lipolysis. During the 12 weeks there were no episode of DKA or hypoglycemia (&amp;lt;55mg/dl). Conclusions Adjunct therapies treatment in T1DM results in significant improvements in glycemia and HbA1c. Dapagliflozin treatment increases lipolysis and glucagon while reduces urinary excretion of BHB. This may contribute to the increased blood ketone levels following extended treatment with dapagliflozin. However, the magnitude of this increase in ketones is significantly below DKA ketones levels which indicates that other DKA triggering factors play a more significant role. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

RF34 | PMON263 Study of Testosterone Replacement in Hypogonadal Men With Uncontrolled Type 2 Diabetes – a Randomised Double Blinded Placebo Controlled Trial (STRIDE Study)

Abstract Objective This RCT set out to test the effect of testosterone on glycaemic control, parameters of metabolic control and quality of life(QoL) in a cohort of people with poorly-controlled type 2 diabetes and hypogonadism. Research design and methods: This is a randomised double-blinded placebo-controlled add-on trial of intramuscular testosterone undecanoate (Nebido®) administered every 12 weeks in 65 hypogonadal men with poorly-controlled type 2 diabetes. Phase 1 patients were randomly assigned to either treatment or placebo arm for 6 months of TRT. Phase 2 was an open-labelled phase for 6 months and patients on placebo moved on to the treatment group wherein patients in the treatment group continued. Anthropometric measurements, questionnaires and biochemical parameters were recorded at baseline and every three months for a year. Results Mean age of the cohort was 59±8.98 years(mean±SD). Mean duration since diagnosis of diabetes was 8.6 years. 17(26%) were on insulin. Baseline cohorts were comparable. There was no improvement in mean HbA1c or fasting plasma glucose(FBG) between the active and placebo groups after 6 months of TRT. No difference was found in HbA1c or FBG at 12 months compared to baseline in the active group either. Our study also showed a significant decrease in serum triglycerides (-0.497±0.213mmol/l, p=0.023) and improvement in left hand grip strength (p=0.025) at 6 months post treatment in the active group compared to placebo group. There was no significant difference in the mean weight, BMI, WC, WHR, fat mass, fat percentage or fat free mass between the groups. Our study is the first ever RCT to show a significant improvement in total AMS (aging male symptom) scores from baseline after 6 months of TU treatment compared to placebo group (p&amp;lt;0.05) in a cohort with poorly-controlled type 2 diabetes and hypogonadism. Another key finding from our study substantiating the clinical argument of treatment of patients with hypogonadism in diabetes cohort is that the proportion of patients with severe symptoms moving to a less severe category (low/mild/moderate severity) was 46% in the active vs only 28% in placebo group(p=0.0024). Conclusions Our study concludes that testosterone therapy did not have a significant improvement in glycaemic control at 6 months between the active and placebo groups and at 12 months within the in the active group and may need longer duration to see the positive effects especially in cohort of people who have had long duration of diabetes. There was a significant reduction in triglyceride levels and increase muscular strength after 6 months of TRT. STRIDE study is the first ever RCT to show a significant improvement in clinical symptoms and symptom severity following testosterone treatment in patients with hypogonadism and type 2 diabetes after 6 months of testosterone treatment. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m., Monday, June 13, 2022 12:42 p.m. - 12:47 p.m.

Long-term glucose-lowering effect of intermittently scanned continuous glucose monitoring for type 1 diabetes patients in poor glycaemic control from Region North Denmark: An observational real-world cohort study.

BackgroundLowering glucose levels is a complex task for patients with type 1 diabetes, and they often lack contact with health care professionals. Intermittently scanned continuous glucose monitoring (isCGM) has the potential to aid them with blood glucose management at home. The aim of this study was to investigate the long-term effect of isCGM on HbA1c in type 1 diabetes patients with poor glycaemic control in a region-wide real-world setting.MethodsAll patients with type 1 diabetes receiving an isCGM due to poor glycaemic control (≥70 mmol/mol [≥8.6%]) in the period of 2020–21 in Region North Denmark (“T1D-CGM”) were compared with all type 1 diabetes patients without isCGM (“T1D-NOCGM”) in the same period. A multiple linear regression model adjusted for age, sex, diabetes duration and use of continuous subcutaneous insulin infusion was constructed to estimate the difference in change from baseline HbA1c between the two groups and within subgroups of T1D-CGM.ResultsA total of 2,527 patients (T1D-CGM: 897; T1D-NOCGM: 1,630) were included in the study. The estimated adjusted difference in change from baseline HbA1c between T1D-CGM vs T1D-NOCGM was -5.68 mmol/mol (95% CI: (-6.69 to -4.67 mmol/mol; p<0.0001)). Older patients using isCGM dropped less in HbA1c.ConclusionsOur results indicate that patients with type 1 diabetes in poor glycaemic control from Region North Denmark in general benefit from using isCGM with a sustained 24-month improvement in HbA1c, but the effect on HbA1c may be less pronounced for older patients.

Weight gain in type 1 diabetes during the SARS-CoV-2 pandemic. Does lockdown affect the metabolic control of pediatric patients?

Background and aimsDue to the severe acute respiratory syndrome coronavirus 2 pandemic, governments of many countries decided to implement lockdowns, which included school closures. This major lifestyle change also applied to people with diabetes. The aim of this paper was to analyze how the COVID-19 pandemic and related restrictions influenced the metabolic compensation of diabetes in the pediatric population.MethodsPatients with type 1 diabetes (T1D), treated by one therapeutic team, who in 2020 and 2021 paid at least two in-person visits in the outpatient clinic, were included in the study. The time in range (TIR) and HbA1c, as well as the total daily dose (TDD) of insulin and BMI from the visit before the announcement of the pandemic restrictions (March 2020) and during the lockdown (second visit after 6 months) and within the period of loosened restrictions (two visits in 2021) were analyzed.ResultsA total of 185 patients with T1D were included in the study (96 boys), aged 2–18 years (11.5 ± 3.5); 135 of them (72.9%) use CSII and 142 (76.8%) use CGM or FGM. During the first months of the studied period, despite comparable (p>0.05) TIR (57.5 ± 21.4% vs. 59.9 ± 20.5%), improvement of HbA1c was noticed (7.9 ± 1.6% vs. 7.5 ± 1.4%, p=0.0336), whereas in the following months, both HbA1c and TIR were comparable. Also, the TDD increased significantly (from 37.3 ± 18.9 units/day on the first visit up to 46.8 ± 22.7 units/day on the last visit, p=0.0003); however, TDD/kg remained constant (p>0.05) (0.8 ± 0.2 units/kg/day vs. 0.8 ± 0.3 units/kg/day) possibly due to an increased BMI (19.1 ± 3.7 kg/m2 vs. 20.9 ± 4.1 kg/m2, p=0.0001). The percentage of basal insulin in the TDD remained stable (p>0.05) (39.7 ± 11.3% vs. 39.3 ± 13.6%). Furthermore, a significant (p=0.0001) change in the BMI percentile was noticed [from 58.9 ± 26.2 percentiles (%iles) before lockdown vs. 64.6 ± 26.0%iles on the second visit]. However, the BMI percentile returned to baseline (58.1 ± 28.4%iles) at the visit at the end of the observation period.ConclusionsThe parameters of metabolic control in pediatric patients with T1D during the pandemic period remained stable; however, weight gain and an increase in daily insulin dose have been observed, possibly due to reduced physical activity.

Effect of nationwide reimbursement of real-time continuous glucose monitoring on HbA1c, hypoglycemia and quality of life in a pediatric type 1 diabetes population: The RESCUE-pediatrics study.

ObjectiveReal-time continuous glucose monitoring (RT-CGM) can improve metabolic control and quality of life (QoL), but long-term real-world data in children with type 1 diabetes (T1D) are scarce. Over a period of 24 months, we assessed the impact of RT-CGM reimbursement on glycemic control and QoL in children/adolescents with T1D treated with insulin pumps.Research design and methodsWe conducted a multicenter prospective observational study. Primary endpoint was the change in HbA1c. Secondary endpoints included change in time in hypoglycemia, QoL, hospitalizations for hypoglycemia and/or ketoacidosis and absenteeism (school for children, work for parents).ResultsBetween December 2014 and February 2019, 75 children/adolescents were followed for 12 (n = 62) and 24 months (n = 50). Baseline HbA1c was 7.2 ± 0.7% (55 ± 8mmol/mol) compared to 7.1 ± 0.8% (54 ± 9mmol/mol) at 24 months (p = 1.0). Participants with a baseline HbA1c ≥ 7.5% (n = 27, mean 8.0 ± 0.3%; 64 ± 3mmol/mol) showed an improvement at 4 months (7.6 ± 0.7%; 60 ± 8mmol/mol; p = 0.009) and at 8 months (7.5 ± 0.6%; 58 ± 7mmol/mol; p = 0.006), but not anymore thereafter (endpoint 24 months: 7.7 ± 0.9%; 61 ± 10mmol/mol; p = 0.2). Time in hypoglycemia did not change over time. QoL for parents and children remained stable. Need for assistance by ambulance due to hypoglycemia reduced from 8 to zero times per 100 patient-years (p = 0.02) and work absenteeism for parents decreased from 411 to 214 days per 100 patient-years (p = 0.03), after 24 months.ConclusionRT-CGM in pump-treated children/adolescents with T1D showed a temporary improvement in HbA1c in participants with a baseline HbA1c ≥ 7.5%, without increasing time in hypoglycemia. QoL was not affected. Importantly, RT-CGM reduced the need for assistance by ambulance due to hypoglycemia and reduced work absenteeism for parents after 24 months.Clinical trial registration[ClinicalTrials.gov], identifier [NCT02601729].

Effect of vitamin D replacement therapy on laboratory parameters in hepatitis C virus cirrhotic patients

Background Liver is a crucial organ for vitamin D metabolism, so vitamin D deficiency is prevalent in liver cirrhosis patients. Hepatitis C is also a global infective disease caused by hepatitis C virus (HCV) and chronic hepatitis leads to liver cirrhosis. Aim To evaluate vitamin D replacement therapy effect through laboratory parameters in HCV cirrhotic patients. Patients and methods Actual enrollment of 25 HCV cirrhotic patients (compensated and decompensated) with a 25(OH)D level of less than 30 ng/ml. All study population are subjected to be investigated at the baseline visit for 25(OH)D, ionized calcium, parathyroid hormone, complete blood count, random blood sugar, glycated hemoglobin (HbA1C), renal function tests, and liver function tests. Study participants received appointments for follow-up visits during the 12 weeks of vitamin D replacement therapy. Results After 3 months of vitamin D replacement therapy, the vitamin D level significantly improved (P=0.001), with significant increase in ionized calcium (P=0.001) and HbA1C (P=0.001). Vitamin D was significantly decreased as the Child score progressed from A to C (P=0.001). There was a significantly negative correlation among vitamin D level, Child score, and prothrombin time. However there was significant positive correlation among vitamin D level, platelet count, albumin, and ionized calcium. These correlations were before and after treatment. Conclusion In HCV cirrhotic patients, supplementation with vitamin D significantly increased 25(OH)D level and ionized calcium. Also, this was associated with improvement of HbA1C, but there was no significant effect on liver function parameters.

Impact of COVID-19 Lockdown on Glycemic Control in Patients with Type 2 Diabetes Mellitus in Dubai.

The objective of this study is to evaluate the impact of the COVID-19 lockdown on glycemic control and accompanying laboratory parameters in patients with type 2 Diabetes Mellitus. This study is a retrospective cohort study that was done on a multicenter level. It was conducted during the lockdown in 341 individuals. HbA1c was tested to measure glycemic control immediately before and after the lockdown period that lasted for 13 weeks. The primary outcome was the improvement of mean HbA1C after 13 weeks of lockdown compared to the pre-lockdown HbA1C. It was found that the mean HbA1C improved from 7.5±1.5 to 7.3±1.5 with a p-value of 0.001. Our study showed that patients with type 2 diabetes mellitus exhibited an improvement in their glycemic control after the period of lockdown.

Peer support and social networking interventions in diabetes self-management in Kenya and Uganda: A scoping review.

BackgroundDiabetes mellitus is a growing worldwide health challenge especially in sub-Saharan Africa. While the use and effectiveness of diabetes self-management interventions is well documented in high-income countries, little information exists in sub-Saharan Africa. Therefore, this study attempted to synthesize information in the literature on the use and efficacy of peer support and social networking in diabetes self-management in Kenya and Uganda.ObjectiveThe purpose of this scoping review is to summarize research on the extent of use and efficacy of peer support and social networking interventions in diabetes self-management in Kenya and Uganda.DesignWe searched PubMed, ScienceDirect and Cochrane Library databases for articles reporting peer support and social networking interventions in Kenya and Uganda published in English between 2000 and September 2021. Key words encapsulated three major themes: peer support, social networking and self-management. Hand searches were also conducted to select eligible papers. Data was extracted using a form prepared and piloted in line with PRISMA-ScR guidelines.ResultsThirteen peer reviewed articles were selected for analysis. Eleven studies reported peer support interventions while two focused on social networks in diabetes self-management. Peer support and social networking interventions incorporated microfinance and group medical visits, diabetes self-management education, telephone support and Medication Adherence Clubs. Most interventions were delivered by multidisciplinary teams comprising nurses and other professionals, peer educators, peer leaders and community health workers. Most interventions were effective and led to improvements in HbA1c and blood pressure, eating behaviors and physical activity and social support.ConclusionsThe limited studies available show that peer support and social networking interventions have mixed results on health and other outcomes. Importantly, most studies reported significant improvements in clinical outcomes. Further research is needed on the nature and mechanisms through which peer support and social network characteristics affect health outcomes.

Effects of One-Stage Full-Mouth Scaling and Root Planing with Azithromycin on Diabetes and Periodontal Disease: A Randomized Controlled Trial.

Recent reports show that hemoglobin A1c (HbA1c) can be lowered by improving chronic inflammation in periodontal patients with diabetes mellitus and that full-mouth scaling and root planing (FM-SRP), in combination with azithromycin (AZM) treatment, can reduce early periodontal inflammation. However, the association of FM-SRP and AZM with periodontitis and HbA1c in patients with diabetes is largely unknown. This study investigated periodontitis and HbA1c in patients with diabetes after receiving FM-SRP and AZM to evaluate which clinical parameters most reflect the diabetic condition. Fifty-one periodontal patients with diabetes mellitus were included in this study. In total, 25 patients were assigned to the FM-SRP group in which patients were treated with FM-SRP in combination with AZM, and 26 patients were assigned to the control group in which only supragingival calculus removal was performed along with the provision of oral hygiene instructions. We evaluated periodontal parameters (probing pocket depth, periodontal inflamed surface area (PISA), bleeding on probing), and periodontal bacteria and biochemical parameters (HbA1c, high-sensitive C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and monocyte chemoattractant protein-1 (MCP-1)) at baseline (BL) and 1, 3, 6, and 9 months after treatment. Compared with BL values, the FM-SRP group showed improved clinical parameters, reduced periodontal pathogens, and significantly lower HbA1c. Inflammatory cytokines (hs-CRP, TNF-α, IL-6) were significantly reduced one month after treatment and remained low thereafter. MCP-1 did not change significantly during the experimental period. PISA showed a strong correlation with HbA1c, hs-CRP, and TNF-α. FM-SRP, in combination with AZM, produced clinical, microbiological, and HbA1c improvements in periodontal patients with previously diagnosed diabetes mellitus. Additionally, PISA was shown to be a useful index for assessing the diabetic status of patients with periodontal disease.