Change In A1c Research Articles

A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics.

Eating a healthy diet is important for managing diabetes. Although there are high rates of diabetes in low-income urban areas, these patients often have limited access to fruits and vegetables. The 15-week Fresh Prescription (Fresh Rx) program was designed to improve access and consumption of fruits and vegetables among low-income patients with diabetes in Detroit, MI. The purpose of this study was to evaluate the effects of a fruit and vegetable prescription program on changes in hemoglobin A1C (HbA1C), blood pressure (BP), and body mass index (BMI) in patients with diabetes in a randomized controlled trial at a federally qualified health center (FQHC). Patients randomized to the Fresh Rx group (n=56) were allotted up to $80 ($10 for up to eight weeks) for purchase of produce from a farmers market based at the FQHC. The control group (n=56) received standard treatment plus information on community resources to improve health. Outcomes were compared at baseline and within three months of program completion. There were no significant between-group differences for any of the outcomes at program completion (p>.05); however, there was a small effect size for HbA1c (partialη2=0.02). Within the Fresh Rx group, HbA1c significantly decreased from 9.64% to 9.14% (p=0.006). However, no changes were noted within the control group (9.38 to 9.41%,p=0.89). BMI and BP did not change from pre- to post-study in either group (p>.05). Results from this study offer preliminary evidence that produce prescription programs may reduce HbA1C in low-income patients with diabetes.

Abstract #1003259: Systematic Review and Meta-Analysis of MiniMed™ 670G System Therapy on Change in A1C and Time Spent in Target Glucose Range

Despite pharmacological and technological advances, a majority of patients still fail to achieve national and international consensus-recommended goals for glycated hemoglobin (A1C) and percentage of time spent in target glucose range (TIR). Technological advances including hybrid closed-loop (HCL) systems, that automatically deliver basal insulin based on continuous glucose monitoring (CGM) data, have demonstrated improved A1C and TIR, compared to baseline. A systematic review and meta-analysis synthesized data from scholarly evaluations of the MiniMed™ 670G system, the first HCL system approved for T1D in the U.S., to determine its impact on A1C and TIR.

Impact of a "Pharmacist First" innovative workflow plan in patients with hypertension and/or diabetes.

Usual community pharmacy workflow, whereby patients might see a pharmacist at the end of the dispensing process, is not conducive to proactive patient-centred care. The objective of this study was to evaluate the impact of the “Pharmacist First” (P1st) workflow model on blood pressure and glycemic control in patients with hypertension and/or diabetes. This retrospective review was set in 2 community pharmacies that use the P1st model in the Greater Edmonton Region. The population entailed patients with hypertension and/or type 1 or 2 diabetes who received care via the P1st workflow model. The P1st workflow model places the patient in immediate contact with the pharmacist. The pharmacist first assesses prescription appropriateness, reviews relevant laboratory tests, discusses chronic disease control and addresses any questions or concerns the patient has before passing the prescription to be filled by a technician. This allows issues or concerns to be identified and addressed up front, rather than waiting until the prescription is filled and the patient is ready to leave the pharmacy. The primary outcome assessed in this study was change in blood pressure and/or A1C from baseline to the last follow-up visit. We reviewed 215 patient records. The mean age was 69.4 years (standard deviation 12.5), 51.2% of patients were male, 57.7% had hypertension, 5.6% had diabetes, and 36.7% had both. Median follow-up time was 4.2 months (interquartile range 2.5-9.3). In 203 patients with hypertension, systolic blood pressure was reduced from 139.83 mmHg to 131.26 mmHg (p < 0.001) and diastolic blood pressure from 80.26 mmHg to 76.86 mmHg (p < 0.001). In 87 patients with diabetes, A1C changed from 7.4% to 7.2% (p = ns). The P1st workflow model demonstrated significant improvements in blood pressure. Further investigation is needed to evaluate the effectiveness of this model with a control group, longer follow-up and evaluation of the patient experience.

Effect of Covid-19 quarantine on diabetes Care in Children

BackgroundWith the onset of the COVID-19 pandemic and state-mandated school closures in the spring of 2020, the management of type 1 diabetes in children underwent significant changes. The aim of our study was to assess the effect of stay-at-home orders on glycemic control in children.MethodsWe conducted a retrospective review of 238 children with type 1 and type 2 diabetes who were seen in the Pediatric Endocrinology Clinic at the University of South Alabama. Average Hemoglobin A1c (A1c) levels in the year prior to stay-at home orders (May 2019–April 2020) were compared with A1c values during the quarantine period (May 2020–July 2020) using a paired t-test. We also analyzed the change of A1c level with respect to sex, race, type of diabetes, type of insurance, and mode of insulin administration, using a 2-sample t-test.ResultsThe average A1c significantly increased from 9.2% during the previous year to 9.5% during the quarantine period (p = 0.0097). The increase of A1c was significantly higher in public insurance patients (0.49% increase) compared to private insurance patients (0.03% increase), (p = 0.0137). We also observed a significant association between the direction of change and type of insurance. Forty-eight percent of public insurance patients had an A1c increase of > 0.5% while 54% of private insurance patients had no change or decrease in A1c (p = 0.0079).ConclusionsThe COVID-19 pandemic resulted in worsening glycemic control in children with type 1 diabetes, with those on public insurance affected in greater proportion than those with private insurance.

Weight Gain in Veterans Taking Duloxetine, Pregabalin, or Both for the Treatment of Neuropathy.

Peripheral neuropathy is a common condition with an estimated incidence of 3 million cases in the United States per year, with manifestations including weakness, numbness, burning or tingling sensations, and lingering pain. The burden of neuropathy may be greater among veterans due to the higher prevalence of type 2 diabetes mellitus (T2DM) and an aging population. Among the medications used to treat neuropathy are duloxetine and pregabalin. It has been observed at the Sioux Falls Veterans Affairs Health Care System (SFVAHCS) that veterans who are treated for neuropathy with duloxetine, pregabalin, or both, may experience significant weight gain after starting therapy. The purpose of this study was to evaluate the association of weight gain in veterans taking duloxetine, pregabalin, or both, for the treatment of neuropathy. This was a retrospective, chart review study conducted at the SFVAHCS. The primary end point of this study was the change in body weight, expressed in pounds, after 12 to 18 months of treatment. The secondary end points of this study were the percent change in body weight; duration effect; dose effect, which evaluated weight gain at doses of duloxetine > 60 mg/d and pregabalin at doses > 300 mg/d; change in hemoglobin A1c in patients with prediabetes and T2DM, and involvement in the Managing Overweight Veterans Everywhere (MOVE!) weight management program. The change in body weight after 12 to 18 months of treatment was -0.8 lb in the duloxetine group, +2.9 lb in the pregabalin group, and +5.5 lb in the pregabalin plus duloxetine group (P = .12). The change in body weight after > 12 months of treatment was -0.88 lb in the duloxetine group, +3.6 lb in the pregabalin group, and +8.5 lb in the duloxetine plus pregabalin group (P = .046). The change in body weight in patients who received increased doses of the study agents was -2.8 lb in the duloxetine group and +6.5 lb in the pregabalin group (P = .047). There was no significant difference in weight in veterans who took duloxetine, pregabalin, or both, for treatment of neuropathy after 12 to 18 months of therapy. However, there was a difference in weight gain among the 3 groups when therapy lasted > 12 months. The combination therapy of pregabalin and duloxetine was associated with the most amount of weight gain, followed by pregabalin alone. Monotherapy of duloxetine had minimal association with weight gain. In veterans who took increased doses of duloxetine or pregabalin, there was a difference in weight between the monotherapy groups, with pregabalin associated with weight gain and duloxetine associated with weight loss.

Lifestyle changes and their impact on glycemic control and weight control in patients with diabetes during the coronavirus disease 2019 pandemic in Japan.

Aims/IntroductionThis study aimed to reveal lifestyle changes and their impact on glycemic control and weight control in patients with diabetes during the coronavirus disease 2019 (COVID‐19) pandemic in Japan.Materials and MethodsWe retrospectively analyzed 1,402 outpatients with diabetes at a clinic in Osaka, Japan, who responded to an interview sheet regarding lifestyle changes during the COVID‐19 pandemic between 28 March and 30 May 2020. The association of lifestyle changes with hemoglobin A1c (HbA1c) and weight changes from February to May 2020 was investigated using the linear regression model. We also investigated the association with clinically important change of HbA1c (by ≥0.3%) and bodyweight (by ≥3%), using the cumulative link model.ResultsLeisure time and other outside physical activities were decreased in one‐quarter of patients during the COVID‐19 pandemic, whereas the amount of meals and snacks was decreased and increased in approximately 10%, respectively. The change in leisure time physical activities was inversely associated with HbA1c and weight changes, whereas the quantitative change of meals with the decline in eating out and that of snacks were positively associated with HbA1c and weight changes (all P < 0.05). The quantitative change of meals without the decline in eating out was also positively associated with weight change (P = 0.012). The cumulative link model for clinically important HbA1c and weight change showed broadly similar associations, except for that between snacks and bodyweight (P = 0.15).ConclusionsA considerable number of outpatients with diabetes experienced lifestyle changes during the COVID‐19 pandemic. The lifestyle changes were associated with HbA1c and weight changes.

Effect of Long-Term Metreleptin Treatment on Glycemic Control in Rabson-Mendenhall Syndrome

Abstract Rabson-Mendenhall Syndrome is caused by mutations of the insulin receptor, resulting in extreme hyperinsulinemia and poorly controlled diabetes. We examined whether long-term treatment with metreleptin, a recombinant analog of the hormone leptin, improves glycemia in patients with Rabson-Mendenhall Syndrome. We measured HbA1c in 11 patients with Rabson-Mendenhall Syndrome treated with high-dose metreleptin (≥0.15 mg/kg/day) after 6, 12, 18, 24, 36, 48, and 60 months, and at last follow up in patients treated &amp;gt;60 months (mean 90 months). We measured HbA1c over a comparable time frame in 7 untreated patients with Rabson-Mendenhall syndrome. 5 of these patients were also in the treatment group and were studied prior to starting metreleptin treatment or after metreleptin withdrawal. 2 patients in the untreated cohort were never treated with high-dose metreleptin. We calculated change in A1c from baseline at each of these timepoints in both the treated and untreated groups. At baseline the treatment group had similar age (13.8±5.0 vs 11.3±5.3 years, P=0.35) and trended toward higher A1c (10.7%±1.5 vs 8.9%±2.3%, P=0.08). All analyses were therefore adjusted for baseline A1c. In the untreated group, A1c increased non-significantly over time (P=0.2). Least-square mean change in A1c from baseline was 0.2%±1.4%, 0.2%±1.6%, 0.8%±1.5%, 1.0%±1.5%, 1.8%±1.5%, 1.5%±1.5%, 0.9%±1.4%, and 2.4%±1.4%. at 6, 12, 18, 24, 36, 48, and ~90 months of follow-up. During high-dose metreleptin treatment, A1c decreased non-significantly over time (P=0.2). Least square mean change in A1c from baseline was -1.9%±1.7%, -1.4%±1.8%, -1.0%±1.7%, -1.1%±1.7%, -1.1%±1.7%, -1.5%±1.7%, -0.6%±1.7%, and -0.2%±1.7% at 0, 6, 12, 18, 24, 36, 48, and ~90 months of follow-up. Reductions in A1c after metreleptin were statistically significant at months 6 (p=0.009), 12 (p=0.03), and 48 (p=0.04). Over time, A1c was 1.4% higher in the untreated group vs. the metreleptin treated group (P=0.04). These results suggest that treatment with metreleptin may lower A1c over time in patients with Rabson-Mendenhall syndrome. Better glycemic control, as indicated by lower average HbA1c levels, may reduce the risk of diabetic complications over time.

Efficacy of Dulaglutide Expanded Doses by Baseline A1C Categories: Post Hoc Analysis of AWARD-11

The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide (DU) once weekly doses of 3 mg and 4.5 mg compared to DU 1.5 mg in patients with type 2 diabetes (T2D) inadequately controlled with metformin monotherapy. This exploratory post hoc analysis of AWARD-11 assessed the effect of dulaglutide on A1C reduction by clinically-relevant baseline A1C subgroups (<8%; 8%-<9%; 9%-<10%; ≥10%) and the proportion of patients achieving A1C <7% in these subgroups through 36 and 52 weeks. Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614). All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose. A mixed effects model for repeated measures was used within the A1C subgroups to assess the change in A1C from baseline at 36 and 52 weeks. A longitudinal logistic regression model was used within subgroups to analyze the proportion of patients achieving A1C <7% at 36 and 52 weeks. Efficacy analyses used data collected up to initiation of rescue medication or premature treatment discontinuation, if either occurred. DU 1.5 mg reduced A1C across all baseline A1C categories at 36 weeks (range, -1.0 to -2.2%) and effects were sustained through 52 weeks (range, -1.0 to -2.1%). A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks (A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3; A1C ≥10%, -2.2, -2.5, -3.2; interaction p<0.001). More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs. Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096). Similar patterns of dose-related improvement in A1C and proportions of patients achieving A1C <7% across baseline A1C categories were observed at 52 weeks. Gastrointestinal adverse events were similar between A1C subgroups. Glycemic control as measured by A1C and proportion of patients achieving A1C <7% was improved with DU dose escalation from 1.5 mg to 3 mg or 4.5 mg across a spectrum of clinically relevant baseline A1C categories without increasing incidence of GI adverse events. Patients at higher baseline A1Cs (9%-<10% and ≥10%) had larger dose-related improvements in glycemic control than those at lower baseline A1Cs (<8% and 8%-<9%). The majority of patients randomized to DU 4.5 mg achieved glycemic target across all categories of baseline A1C.

Volanesorsen, an Antisense Oligonucleotide to Apolipoprotein-CIII, Decreases Triglycerides and Increases Lipoprotein Lipase Activity in Partial Lipodystrophy

Partial lipodystrophy syndromes (PL) involve selective deficiency of adipose tissue, with regional deficiency of fat in the lower extremities and preservation or even excess fat in the face and neck. Clinical features typical of PL include severe insulin resistance, diabetes mellitus, hypertriglyceridemia and non-alcoholic fatty liver disease. Apolipoprotein CIII (Apo-CIII) is elevated in PL, and is thought to contribute to high TG by inhibiting lipoprotein lipase (LPL). However, prior studies of this drug in patients with LPL mutations demonstrated LPL-independent mechanisms of TG-lowering. We hypothesized that Volanesorsen, an antisense oligonucleotide (ASO) to apo-CIII, would decrease apo-CIII, increase LPL activity, and lower TG in PL. We further hypothesized that Volanesorsen would improve insulin resistance and glycemia by directing free fatty acids (FFA) into adipose tissue, rather than ectopic sites (e.g. liver) associated with insulin resistance. Five adults with PL and TG ≥500 mg/dL or TG≥200 with A1c >7.0% were enrolled in a 16-week placebo-controlled, randomized, double blind study of Volanesorsen, 300 mg SC weekly, followed by a 1-year open label extension. Here, we report within-subject effects of Volanesorsen lipids, glycemia and lipolysis, before and after 16 weeks of active drug. From week 0 to week 16, apoC-III decreased from 380 (246, 600) to 75 (26, 232) ng/mL, TG decreased from 503 (330, 1040) to 116 (86, 355) mg/dL; and LPL activity measured in post-heparin plasma utilizing the subject’s serum as activator increased from 22.0±3.0 to 35.5±5.9 nEq/ml/min. Free fatty acid turnover (measured by palmitate tracer studies) decreased from 0.41 (0.35, 0.45) to 0.25 (0.23, 0.29) mg/kg/min. There was no change in A1c (8.4±1.2 to 8.3±0.9%), however there was a decrease in HOMA-IR from 26 (20, 54) to 13 (9, 43) and an increase in peripheral insulin sensitivity (glucose infusion rate during euglycemic hyperinsulinemic clamp, 120 mU/m2/min) from 3.6±2.4 to 4.4±1.5 mg/kgFFM/min and in hepatic insulin sensitivity (% suppression of hepatic glucose production during clamp) from 78±19 to 90±13%. Adverse events include injection site reactions and decreased platelets. Volanesorsen decreased apo-CIII and triglycerides, at least in part through an LPL dependent mechanism, and may improve insulin resistance.

Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D)

Advances in diabetes technology have transformed the treatment paradigm for T1D, yet the burden of the disease remains significant. The pediatric population poses unique challenges to glucose management with unpredictable exercise and food consumption. The Omnipod 5 System is a novel hybrid closed-loop (HCL) system with fully on-body operation. A tubeless insulin pump (pod) containing a personalized Model Predictive Control algorithm communicates directly with a Dexcom G6 continuous glucose monitor (CGM, or sensor) to automate insulin delivery. Therapy customization is enabled through glucose targets from 110–150 mg/dL, adjustable by time of day, which is a critical component to individualize glucose management in children. We report on the first, pivotal outpatient safety evaluation of the Omnipod 5 System in a large cohort of children with T1D.Participants aged 6–13.9y with T1D≥6 months and A1C<10% used the HCL system for 3 months at home after a 14-day run-in phase of their standard therapy (ST, included both pump therapy and multiple daily injections). The primary safety and effectiveness endpoints, respectively, were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and change in A1C and sensor glucose percent time in target range (TIR) (70–180 mg/dL) during HCL compared with ST.Participants (N=112) were aged (mean±SD) 10.3±2.2y with T1D duration 4.7±2.6y and baseline A1C 7.7±0.9% (range 5.8–10.3%). TIR increased significantly from ST to HCL, from 52.5±15.6% to 68.0±8.1% (p<0.0001), corresponding to an additional 3.7 hours/day in target range. A1C at end of study was reduced by 0.7% to 7.0±0.6% (p<0.0001). Percentages of time in hyperglycemia were reduced: >180 mg/dL from 45.3±16.7% to 30.2±8.7% and ≥250 mg/dL from 19.1±13.1% to 9.6±5.4% (both p<0.0001). Percentages of time in hypoglycemia remained low from ST to HCL: <54 mg/dL from 0.4±0.8% to 0.3±0.3% and <70 mg/dL from 2.2±2.7% to 1.8±1.4% (both p>0.05). Mean glucose decreased from 183±32 to 160±15 mg/dL (p<0.0001). During the HCL phase there was 1 episode of SH (delayed eating after pre-meal bolus) and 1 episode of DKA (suspected infusion site failure) reported. Virtually all participants completing the pivotal study (99%) continued system use during an extension phase.In this multi-center pivotal study in a large cohort of children with T1D, the Omnipod 5 System was safe and effective when used for 3 months at home. There were significant improvements in both TIR and A1C, while time below range (<70 mg/dL) remained low. The beneficial glycemic outcomes are critical for children, given that neurologic outcomes can be negatively impacted by hyperglycemia. The current results and commitment to the extension phase emphasize the safe and effective use of the HCL system, as well as the preference for the Omnipod 5 System over participants’ previous therapy.

Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Adults and Adolescents With Type 1 Diabetes (T1D)

Abstract Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes (T1D), yet the burden of disease remains significant. The Omnipod 5 Automated Insulin Delivery System is a novel hybrid closed-loop (HCL) system with fully on-body operation. The system consists of a tubeless insulin pump (pod) containing a personalized Model Predictive Control algorithm which communicates directly with a Dexcom G6 continuous glucose monitor (CGM, or sensor) to automate insulin delivery. Therapy customization is enabled through glucose targets from 110-150 mg/dL, adjustable by time of day. The system adapts to changing insulin needs with each pod change. We report on the first, pivotal outpatient safety evaluation of the system in a large cohort of adults and adolescents with T1D. Participants aged 14-70y with T1D≥6 months and A1C&amp;lt;10% used the HCL system for 3 months at home after a 14-day run-in phase of their standard therapy (ST). Prior therapy included both pump therapy and multiple daily injections. The primary safety and effectiveness endpoints, respectively, were occurrence of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA), and change in A1C and sensor glucose percent time in target range (TIR) (70-180 mg/dL) during HCL compared with ST. Participants (N=128) were aged (mean±SD) 37±14y with T1D duration 18±12y and baseline A1C 7.2±0.9% (range 5.2-9.8%). There was a significant increase in TIR from ST to HCL, from 64.7±16.6% to 73.9±11.0% (p&amp;lt;0.0001), corresponding to an additional 2.2 hours/day in target range. A1C at end of study was reduced by 0.4%, from 7.2±0.9% to 6.8±0.7% (p&amp;lt;0.0001). Glycemic outcomes for percent of time with CGM readings below and above target range were all reduced (p&amp;lt;0.0001): &amp;lt;54 mg/dL from 0.6±1.2% to 0.2±0.3% (a decrease of 6 minutes/day), &amp;lt;70 mg/dL from 2.9±3.1% to 1.3±1.1% (a decrease of 23 minutes/day), &amp;gt;180 mg/dL from 32.4±17.3% to 24.7±11.2% (a decrease of 1.8 hours/day), and ≥250 mg/dL from 10.1±10.5% to 5.8±5.5% (a decrease of 1.0 hours/day). The mean glucose also decreased from 161±28 to 154±17 mg/dL (p=0.0002). During the 3-month HCL phase there were 2 episodes of SH (both following user-initiated boluses) and no episodes of DKA reported. Most participants completing the pivotal study (92%) opted to continue using the system during an extension phase. In this outpatient, multi-center pivotal study in a large cohort of adults and adolescents with T1D, the Omnipod 5 System was safe and effective when used for 3 months at home. There were significant improvements in both TIR and A1C with use of the system, while time in hypoglycemic ranges was also reduced. The current results and commitment to the extension phase highlight the safe and effective use of the HCL system, as well as the preference for the Omnipod 5 System over participants’ previous therapy.

Effects of Movement Control Order (MCO) During Covid-19 Pandemic on Patients With Diabetes Mellitus (DM) in Malaysian Tertiary Centers

Introduction: The Malaysian government implemented MCO or lockdown for nearly 3 months from 18 Mar to 9 Jun 2020 in response to the Covid-19 pandemic. This restricted access to usual food, workplace, and leisure sports, and also led to reduced clinic attendance. The effects of MCO on patients with chronic lifestyle diseases like DM is unknown. Methodology: This is a cross-sectional study exploring effects of MCO on adult (>18 years) DM patients (both Type 1 and Type 2) attending endocrinologist-run DM clinics in 3 tertiary centres in Malaysia. Glycaemic and metabolic parameters were collected through medical record review while data on healthcare utilisation, dietary and lifestyle habits before MCO (17 Nov 2019 to 17 Mar 2020) and during MCO were collected by investigator-administered questionnaires during routine clinic follow-up after the MCO period (10 Jun to 30 Oct 2020). Results: From a total of 207 patients (56.5% female, 73.4% T2D and 80% on insulin) no significant difference between mean (SD) A1c [8.6(2.39) % vs 8.4(2.14) %; p=0.073] or BMI [29.2(7.57) vs 29.4(9.23)kg/m2; p=0.968] were seen before and during MCO respectively. More than 95% of the patients attended clinic before MCO and at least 20.3% saw either the DM nurse educator, DM pharmacist or dietitian. In contrast, during MCO only 31.4% of patients attended clinic and less than 10% had face-to-face consultation with the DM support team. More patients also reported missing insulin (11.6% vs 7.7%) and not checking blood glucose (17.9% vs 15.5%) during MCO. Before MCO, 61.8% of patients had home-cooked food daily. During MCO this increased to 83.1%. However, there was a trend towards unhealthy eating during MCO. Patients reported eating more frequently with those eating more than 4 meals a day nearly tripled during MCO (18.4% vs 6.8%). In addition, 22% of patients recalled consuming more confectionary; a similar percentage also reported higher consumption of processed food like dry snacks, canned food and instant noodles during MCO. Mean (SD) hours of sleep [6.8 (1.35) vs 7.2 (1.73) hours; p<0.001] and screen time [3.3 (2.51) vs 4.51 (3.10] hours, p< 0.001) increased significantly during MCO compared to before. Notably, before MCO 44% of patients reported no exercise and this increased to 65.7% during MCO. Conclusion: Despite reduced clinic attendance and contact with the DM support team, there were no consequent significant change in A1c or BMI of our DM patients from the 3-month MCO in our short term study. However, a worrying increase in sedentariness and unhealthy eating existed. The imperative need to conduct work or lessons online, among others contributed to the inevitable rise in screen time and reduced physical activity. As the pandemic continues with imposed movement restrictions, the long-term implications of MCO to metabolic health warrant our attention. Innovative strategies to promote healthier living during MCO are urgently needed.

A Multidisciplinary Diabetes Clinic Improves Clinical and Behavioral Outcomes in a Primary Care Setting.

The percentage of adults achieving hemoglobin A1c goals less than 7% remains a challenge. The study objective was to evaluate effects of a multidisciplinary approach on behavioral outcomes and mean change in A1c in immediate start (intervention) versus 6-month delay (control) groups at 6 months. The study assessed 111 patients recruited from a safety-net primary care clinic with a pharmacist-led multidisciplinary team and found that the intervention improved mean A1c outcomes for patients with type 2 diabetes. A1c values were measured every 3 months, and a self-efficacy scale to measure behaviors was evaluated at baseline and 6 months. After 6 months from baseline, the intervention group showed an A1c decrease of 2.4 compared with the control group's 1.1 decrease. Mean increase in self-efficacy score in the intervention group at baseline versus after 6 months showed a statistically significant change (P = .01) compared with the control group (P = .26). Results revealed a post hoc association between A1c and PHQ-9 such that patients with higher baseline PHQ-9 scores experienced greater mean decrease in A1c. In the immediate start arm, mean A1c values decreased from 10.6 at baseline to 7.7 at month 12. For the delayed intervention group, mean A1c values decreased from 10.2 at baseline to 9.0 after 6 months.

Diabetes drug is effective for weight control, study shows

New data support the use of once-weekly S.C. semaglutide plus lifestyle intervention for weight control in patients who are overweight or obese. In a recent clinical trial, patients given semaglutide 2.4 mg weekly lost an average of 15% of their body weight over a 16-month period compared with a 2.4% loss for those given placebo. Novo Nordisk filed a new drug application with FDA in December 2020 seeking approval for use of semaglutide for weight management. “This is by far the most effective intervention we have seen for weight management when you compare it to many of the currently existing drugs,” said corresponding author Robert Kushner, MD, professor of medicine and medical education at Northwestern University Feinberg School of Medicine, in a press release. “Semaglutide sets the bar for a new generation of more-effective weight loss medications.” The STEP 1 trial—Semaglutide Treatment Effect in People with Obesity—randomized 1,961 adult patients without diabetes who had a BMI of 30 or greater, or a BMI of 27 or greater plus one or more weight-related coexisting conditions, to 68 weeks of treatment with once-weekly S.C. semaglutide 2.4 mg (1,306 participants) or placebo (655 participants) plus lifestyle interventions. The completion rate of the trial was high, with 94.3% of patients finishing the 68 weeks. The results, published March 18, 2021, in the New England Journal of Medicine, showed that patients treated with semaglutide had an estimated mean weight change of −14.9% at week 68 compared with −2.4% of patients receiving placebo (P < 0.001). Other benefits included greater reductions in waist circumference and systolic and diastolic blood pressure, as well as changes in A1C, fasting plasma glucose, C-reactive protein, and fasting lipid levels. Both groups reported adverse events at similar percentages—89.7% (semaglutide group) and 86.4% (placebo group). However, more patients in the semaglutide group experienced GI adverse events such as nausea, diarrhea, vomiting, and constipation. These adverse events were mild to moderate, transient, and generally resolved without permanent discontinuation of the regimen. The results observed with semaglutide add to the available data for liraglutide (Saxenda—Novo Nordisk), another glucagon-like peptide-1 (GLP-1) receptor agonist, which is FDA approved for chronic weight management in patients who are overweight or obese. Liraglutide is given once daily as an S.C. injection, and data have shown that the majority of patients treated with this agent experience a 5% or greater reduction in weight loss. Although liraglutide is effective, the need to administer it as a daily injection may be a limiting factor for more widespread use. Along with the GLP-1 agonists, the sodium–glucose cotransporter-2 (SGLT-2) inhibitors have also been effective for weight loss during trials evaluating their use for management of type 2 diabetes. The ability of this class of medications to reduce body weight is moderate, however, because of counter-regulatory mechanisms that work to maintain body weight. Further analyses will evaluate the use of SGLT-2 inhibitors in combination with other agents such as the GLP-1 agonists as a potential weight management strategy. Obesity is a global health challenge that increases the risk for numerous comorbidities and even death. Therefore, effective interventions aimed at helping patients lose weight and keep it off long term are needed. Medications such as phentermine/topiramate (Qsymia—Vivus), naltrexone/bupropion (Contrave—Currax), and orlistat (Alli—GlaxoSmithKline; available OTC) have all been used for weight control, but the results have not been as robust as those observed for semaglutide in the STEP 1 trial. Even so, there is still the need for longer-term data to determine the sustainability of semaglutide for weight loss. Clinicians and patients will also need to consider the drug's delivery as a weekly S.C. injection, how GI adverse events can be managed, and cost implications. Lifestyle modification is the cornerstone of treatment for management of patients who are overweight and obese. Pharmacists can counsel patients on proper nutrition and the need for increased physical activity and inform those who select pharmacotherapy that several treatment options are available. They can also educate patients on the risks and benefits of each treatment option and encourage them throughout their weight loss journey.

Shared Medical Appointments and Prediabetes: The Power of the Group.

Shared medical appointments, which allow greater access to care and provide peer support, may be an effective treatment modality for prediabetes. We used a retrospective propensity-matched cohort analysis to compare patients attending a prediabetes shared medical appointment to usual care. Primary outcome was patient's weight change over 24 months. Secondary outcomes included change in hemoglobin A1c, low density lipoprotein, and systolic blood pressure. The shared medical appointments group lost more weight (2.88 kg vs 1.29 kg, P = .003), and achieved greater reduction in hemoglobin A1c (-0.87% vs +0.87%, P = .001) and systolic blood pressure (-4.35 mmHg vs +0.52 mmHg, P = .044). The shared medical appointment model can be effective in treating prediabetes.

A Review: Comparison of Efficacy of Liraglutide Versus Sitagliptin add-on-to Metformin in Type 2 Diabetes Mellitus patients

Background: The aim of this review is to compare the efficacy of liraglutide versus sitagliptin add-on-to metformin in patients with Type 2 Diabetes Mellitus and inadequate glycemic control for rational use of drugs. Methods: We searched for randomized controlled trials (RCT) in MEDLINE, Web of science, PubMed, Cochrane library, CNKI, and Wanfang database and extracted data from all randomized controlled trials (RCTs) up to July 11, 2019 of liraglutide versus sitagliptin given in combination with metformin. RCTs were selected only if they were RCTs comparing DPP-4 inhibitor (sitagliptin) monotherapy to metformin monotherapy with the GLP-1 Receptor Agonists (liraglutide), duration of treatment was ≥26 weeks and reported data on hemoglobin A1c (HbA1c) change, fasting plasma glucose (FPG) change, Odds ratio (OR), mean difference (MD), 95% confidence interval are used to analyze the outcomes. Results: A total of 2,257 patients from 6 RCTs were included in the study. When compared with sitagliptin (100mg) in combination with metformin group, the group of patients treated with liraglutide1.2mg and 1.8mg and metformin, produced greater reduction in HbA1c, FBG. (95% CI). The group of patients with 1.8mg liraglutide had significant weight loss. The incidence of nausea, hypoglycemic episodes, gastrointestinal problems was higher than the sitagliptin with metformin groups. Conclusions: The results of this study indicated that the liraglutide – metformin combination therapy could significantly lower the HbA1c level and increased reduction of body weight. ADRs such as gastrointestinal problems, hypoglycemic episodes were common in liraglutide treatment group.

Motivational Stage at Continuous Glucose Monitoring (CGM) Initiation in Pediatric Type 1 Diabetes Is Associated With Current Glycemic Control but Does Not Predict Future CGM Adherence or Glycemic Control

ObjectivesThe Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (CGM TIME) Trial is a multicenter, randomized controlled trial in children with type 1 diabetes, comparing simultaneous pump and CGM with CGM initiation 6 months later (Paradigm, Veo, Enlite Sensor, Medtronic Canada). This study addresses the ability of SOCRATES (Stages Of Change Readiness And Treatment Eagerness Scale) to classify children and parents into distinct motivational stages and identify the stages’ association with glycated hemoglobin (A1C) at trial entry and outcomes 6 months after CGM initiation. MethodsNinety-eight of 99 eligible children 10 to 18 years of age and 137 of 141 eligible parents completed SOCRATES at trial entry and 6 months later. Parent-child agreement for motivational stage was determined by weighted kappa. Linear regression was used to examine association between motivational stage and i) A1C at trial entry and ii) change in A1C and CGM adherence 6 months after CGM initiation. ResultsMore than 87% of children and 88% of parents were classified into distinct motivational stages, with weak parent-child agreement. At trial entry, motivational stage was associated with A1C, which was 1.02% higher for children in the Action stage than in the Precontemplation stage (p<0.0001). When compared with children of parents in Precontemplation, A1C for children of parents in the Maintenance and Action stages were 0.83% (p=0.02) and 0.36% (p=0.048) higher, respectively. Precontemplation was associated with shorter diabetes duration. Motivational stage at CGM initiation did not predict change in A1C or CGM adherence 6 months later. ConclusionsSOCRATES can categorize children with type 1 diabetes and their parents into motivational stages. Although motivational stage was associated with glycemic control at trial entry, it did not predict future diabetes-related behaviour or A1C.

Efficacy and Safety of the Novel Dipeptidyl Peptidase-4 Inhibitor Gemigliptin in the Management of Type 2 Diabetes: A Meta-Analysis.

BackgroundNo meta-analysis has holistically analysed and summarised the efficacy and safety of gemigliptin in type 2 diabetes. The meta-analysis addresses this knowledge gap.MethodsElectronic databases were searched for randomised controlled trials (RCTs) involving diabetes patients receiving gemigliptin in the intervention arm and placebo/active comparator in the control arm. The primary outcome was change in haemoglobin A1c (HbA1c). The secondary outcomes were alterations in glucose, glycaemic targets, lipids, insulin resistance, and adverse events.ResultsData from 10 RCTs involving 1,792 patients were analysed. Four had an active control group (ACG), with metformin/dapagliflozin/sitagliptin/glimepiride as the active comparator; six had a passive control group (PCG), with placebo/rosuvastatin as controls. HbA1c reduction by gemigliptin at 24 weeks was comparable to ACG (mean difference [MD], 0.09%; 95% confidence interval [CI], −0.06 to 0.23; P=0.24; I2=0%; moderate certainty of evidence [MCE]), but superior to PCG (MD, −0.91%; 95% CI, −1.18 to −0.63); P<0.01; I2=89%; high certainty of evidence [HCE]). Gemigliptin was superior to PCG regarding achieving HbA1c <7% (12 weeks: odds ratio [OR], 5.91; 95% CI, 1.34 to 26.08; P=0.02; I2=74%; 24 weeks: OR, 4.48; 95% CI, 2.09 to 9.60; P<0.01; I2=69%; HCE). Gemigliptin was comparable to ACG regarding achieving HbA1c <7% after 24 weeks (OR, 0.92; 95% CI, 0.52 to 1.63; P=0.77; I2=66%; MCE). Adverse events were similar between the gemigliptin and control groups (risk ratio [RR], 1.06; 95% CI, 0.82 to 1.36; P=0.66; I2=35%; HCE). The gemigliptin group did not have increased hypoglycaemia (RR, 1.19; 95% CI, 0.62 to 2.28; P=0.61; I2=19%; HCE).ConclusionGemigliptin has good glycaemic efficacy and is well-tolerated over 6 months of use.

A Comparison of Two Diabetes Self-Management Education Programs for the Reduction of Participant A1c Levels.

Compare the effectiveness of two educational teaching methods for diabetic patients. Quasi-experimental study comparing two interventions using a pretest/post-test design. Three clinics within a western U.S. regional health system. 818 adult diabetic participants (60.5 mean age, 52% female) attended one to four sessions between 2013-2017, and had A1c tests within 180 days of first attended session and 30 to 365 days after last attended session. A group-based, highly interactive learning experience (n = 561) and a traditional, lecture-style class (n = 257). Pre and post measures of A1c. Paired t-tests measured change within each group pre-post intervention. Two-sample t-tests measured mean change pre-post intervention between the two groups. Multivariable linear regression measured mean change in A1c between groups, adjusted for pre-test scores and controlling for demographic variables. Both interactive and traditional teaching interventions were effective at significantly reducing patient A1c levels by 1.3 (p < 0.001) and 1.0 (p < 0.001) points respectively. The between groups difference in A1c was not significant, t(512) = 1.66, p = 0.0985, but when controlling for age, pre-A1c and days post-A1c, the interactive intervention was significantly (p < 0.05) more effective reducing patient A1c levels by 0.19 points than the traditional intervention. Group-based, interactive diabetes self-management education programs may be an effective model for reducing patient A1c levels.

Real-World Effectiveness of Once-Weekly Semaglutide From a US Commercially Insured and Medicare Advantage Population

PurposePatients managing type 2 diabetes mellitus (T2DM) often require combination therapy to meet their blood glucose control targets. With limited real-world evidence focused on the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) therapies, the objective of this study was to describe the association between semaglutide once weekly (OW) initiation and changes in hemoglobin A1c (A1c) levels. MethodsThis retrospective, descriptive cohort study used the HealthCore Integrated Research Environment (HIRE) to examine commercially insured and Medicare Advantage patients who had T2DM while taking semaglutide OW from December 1, 2017, to April 30, 2019. The first semaglutide OW prescription fill was defined as the study index date. Changes in mean A1c levels and A1c target attainment were evaluated among an intention-to-treat (ITT) population (overall group). Furthermore, a persistent population (PP) analysis on the same outcomes was performed that was limited to ITT patients who were observed to continue to use semaglutide OW at the time of the postindex A1c measurement. In addition, these outcomes were explored in patients stratified based on prior use of GLP-1RA therapy (experienced vs naive) and baseline A1c values >9% (75 mmol/mol). FindingsA total of 1888 patients were identified in the overall ITT group. The mean change in the overall ITT group between preindex and postindex A1c values was −0.9% percentage points (−9.8 mmol/mol) (mean preindex A1c, 8.2% [66.1 mmol/mol]) and −1.1 percentage points (−12.0 mmol/mol) (mean preindex A1c, 8.2% [66.1 mmol/mol]) in the PP subgroup (all P < 0.001). Among the subgroup of patients with a baseline A1c value >9% (75 mmol/mol), percentage point changes in A1c were −2.2 (−24.0 mmol/mol) and −2.4 (−26.2 mmol/mol) (all P < 0.001). When accounting for prior GLP-1RA use, the GLP-1RA–naive stratum had double the mean reduction in A1c compared with the GLP-1RA–experienced stratum (−1.2 [−13.1 mmol/mol] vs −0.6 [−6.6 mmol/mol] percentage points). ImplicationsSemaglutide OW is associated with clinically and statistically significant A1C reduction and increases in reaching A1 targets using real-world data, even in GLP-1RA–experienced patients, despite more frequent use of insulin or sodium glucose transport protein 2 inhibitors in this group. Target A1c attainment significantly increased overall and within all subgroups and strata, with approximately half of all patients attaining an A1c value <7% (53 mmol/mol) and three-quarters attaining an A1c value <8% (64 mmol/mol).