Significant Improvement In HbA1c Research Articles

123-LB: The Simplici-T1 Trial: Relationship between Glycemic Control and Insulin Dose

The Simplici-T1 trial (NCT03335371), designed to explore the safety and efficacy of TTP399 as an oral adjunctive therapy for T1DM, showed that addition of TTP399 to an optimized insulin regimen produced a statistically significant improvement in HbA1c (-0.32%, p<0.01) and Daytime Time In Range (8%, p<0.05) relative to placebo. The treat-to-target (FPG: ~80-130mg/dL; post meal glucose: <180-200 mg/dL) design of the study allowed changes in insulin dose after the insulin-optimization period. To evaluate the effect that these changes could have on A1c, several pre-planned analyses were performed. A positive correlation was observed between reduction in A1c and both reduction in total insulin (p=0.008) (Figure 1) and bolus insulin dose (p=0.004) in the TTP399-treated group but not in the PBO group. A subgroup analysis, matching on changes in insulin use reveals that, relative to PBO, those treated with TTP399 who maintained the optimized insulin regimen improved A1c by -0.35%, p=0.04 (41%TTP399; 36% PBO). The group that reduced their total insulin dose by more than 0.06U/Kg (i.e.,>10% reduction in total and >20% reduction in bolus insulin dose; 47% TTP399; 33% PBO) improved A1c by -0.41%, p=0.013. These improvements occurred without increasing ketones in plasma or hypoglycemic events. During the 12-week treatment period, 12% of the TTP399 group and 31%of the PBO increased their insulin dose. Disclosure C. Valcarce: Employee; Self; vTv Therapeutics. J.L. Freeman: Employee; Self; vTv Therapeutics. Stock/Shareholder; Self; vTv Therapeutics. Stock/Shareholder; Spouse/Partner; vTv Therapeutics. I. Dunn: None. K. Klein: None. J.B. Buse: Consultant; Self; Cirius Therapeutics, CSL Behring, Neurimmune. Research Support; Self; American Diabetes Association, National Institutes of Health, Novo Nordisk A/S, Patient-Centered Outcomes Research Institute, Sanofi, Tolerion, Inc., vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings, Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg Therapeutics, Novo Nordisk A/S, Senseonics, Inc, vTv Therapeutics, Zafgen, Inc. Funding JDRF; vTv Therapeutics; National Institutes of Health (UL1TR002489)

Registered Dietitian Nutritionists Are Associated with Improved Long-Term Clinical Outcomes in High-Risk Patients

Abstract Objectives Treatment from registered dietitian nutritionists (RDNs) has been shown to improve weight and hemoglobin A1c in high-risk patients, yet little is known about these outcomes long term. The current study investigated the association between RDN care and changes in weight and HbA1c compared to primary care in high-risk patients (BMI ≥35 kg/m2 or HbA1c ≥7%) long term up to 24 months. Methods This was a retrospective cohort study of high-risk adults. Electronic medical records were reviewed for participants who were 18 years or older with BMI ≥35 kg/m2 or HbA1c ≥7.0% at first visit to a patient centered medical home in Boston, MA. Mean change in weight (kg) and HbA1c (%) at six, 12, and 24 months were compared between patients who saw an RDN and patients who received primary care only. Paired sample t-tests and repeated measures ANOVA adjusting for age, sex, gender, days from baseline at follow-up visit, and number of clinic visits at follow-up were used to analyze outcomes. Results 1902 patients with BMI >35 and 1240 patients with a HbA1c >7.0% were included. There was no significant difference in 24-month weight loss between RDN care and standard primary care. HbA1c decreased significantly with RDN care at all time points (P < 0.001). Patients with at least one RDN visit had a significantly greater mean change in HbA1c of −0.8 ± 0.2 (95% CI −1.0 to −0.5) and −0.6 ± 0.1 (95% CI −0.8 to −0.3) after 12 and 24 months from baseline, respectively (P < 0.001). Conclusions RDN care resulted in statistically and clinically significant improvements in HbA1c at 12 and 24 months compared to standard primary care alone. Funding Sources The authors received no specific funding for this work.

Improved Clinical Outcomes with Dulaglutide as Add-on Medication to Oral Antidiabetic Drugs with or Without Insulin in Overweight Indian Patients with Type 2 Diabetes Mellitus: Retrospective Study in a Real-World Setting.

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated several extra-pancreatic benefits in addition to glycemic control. This study retrospectively evaluates the realworld clinical effectiveness of dulaglutide as add-on therapy in overweight patients with inadequately controlled type 2 diabetes mellitus (T2DM). This single-center study included overweight adult patients (N, 85; women, 45) with inadequately controlled T2DM (mean glycated hemoglobin [HbA1c] (standard deviation [SD]), 7.55 [0.43] %; and body mass index [BMI] [SD], 29.01 [2.30] kg/m2) treated with dulaglutide (1.5 mg) once weekly as an add-on therapy. Follow-up improvements in outcomes were analyzed using the paired t-test. Subgroup analysis was performed for selected outcomes. Safety parameters were also evaluated. At the 20-week follow-up, dulaglutide based therapy demonstrated a significant reduction (P<.001) in HbA1c, body weight and BMI, with a mean reduction (MR [SD]) of 0.45 [0.38] %, 5.06 [2.33] kg, and 1.82 [0.81] kg/m2, respectively, in the overall population. Similarly, reduction in urine albumin/creatinine ratio [U-ACR] (6.04 [15.53] mg/g), cholesterol (3.24 [4.14] mg/dL), triglycerides (16.60 [12.39] mg/dL), very-low-density lipoprotein [VLDL] (3.31 [2.48] mg/dL), serum glutamicoxaloacetic transaminase (1.80 [2.92] U/L) and glutamic-pyruvic transaminase (8.00 [5.64] U/L) was also significant (P<.05). Target HbA1c of <7% was achieved in 40% of patients. Reduction in HbA1c and body weight was significant across all subgroups analyzed. Predominantly, gastrointestinal adverse events were reported. Dulaglutide as an add-on therapy was well tolerated with significant improvement in HbA1c, body weight, BMI, U-ACR, lipid fractions and serum transaminases in overweight Indian patients with T2DM.

MON-632 The Effects of a High Intensity Glycemic Program on Weight and BMI

Background:Multiple studies have shown that intensive glycemic control leads to improved HbA1c and delays the onset of complications in diabetes.1 However, improvement in glycemic control has also been associated with weight gain.1 The High A1C (HAC) program uses a multidisciplinary team to provide intensive therapy to patients with HbA1C ≥ 10% over 3 months to improve glycemic control. The aim of this retrospective study is to examine if the HAC program is associated with a significant change in weight and BMI.Methods:Patients enrolled in the HAC program were scheduled for frequent visits over the course of 3 months with an Endocrinologist, nurse practitioner, or diabetes educator. Data from patients with type 2 diabetes enrolled from March 2018 to June 2019 who attended at least 2 appointments was collected. Pre-enrollment HbA1c, weight, BMI, and total daily dose (TDD) of insulin (units/kg/day) were compared to post-enrollment using t-test analysis. Use of weight-lowering anti-hyperglycemic agents such as Metformin, GLP-1 agonists (GLP1A) and SGLT-2 inhibitors (SGLT2i) was collected.Results:44 patients were enrolled with 39/44 (88.6%) attending at least 2 visits and 5/44 (11.3%) who were lost to follow-up. The median HbA1c improved from 11.5% (9.7-14%) to 8.4% (5.9-14%), p<0.001.There was no significant change in mean weight (195lbs (110-360) vs 192lbs (114-358), p=0.14) or BMI (31 (20-49) vs 31 (21-49) kg/m2, p=0.86). Pre-enrollment, 33/39 (84.6%) patients were on Metformin, 10/39 (25.6%) were on a GLP1A, and 3/39 (7.7%) were on a SGLT2i. At the end of the program, there were 34/39 (87%) patients on Metformin, 26/39 (66.6%) on a GLP1A, and 17/39 (43.5%) on a SGLT2i. There was no difference in the mean TDD of insulin at the start of the program of 0.63 units/kg/day (0-3.52 units/kg/day) compared to 0.60 units/kg/day (0-4.07 units/kg/day) at the end of the program (p=0.97).Conclusions:Patients enrolled in a high intensity glycemic control program had significant improvements in HbA1c without change in weight or BMI. Additional adjunctive non-insulin therapies and lifestyle management may be contributing factors for weight neutrality in our population. The significant improvement in HbA1c was not linked with increases in TDD of insulin.Citation:1.“U.K. Prospective Diabetes Study Group: Intensive blood glucose control with sulfonylureas or insulin compared with convention treatment and risk of complications in patients with Type 2 Diabetes.” Lancet, vol.353, 1998, pp.837-53.

Switching from Neutral Protamine Hagedorn Insulin to Insulin Glargine 300 U/mL Improves Glycaemic Control and Reduces Hypoglycaemia Risk: Results of a Multicentre, Prospective, Observational Study.

Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality worldwide and is an important public health issue. A significant proportion of insulin-treated patients with T2DM do not reach target glycated haemoglobin (HbA1c) values, which ultimately increases their risk of long-term microvascular and macrovascular complications. One potential option to improve diabetes control in these patients may be the use of new insulin formulations including second-generation basal insulin analogues such as insulin glargine 300 U/mL (Gla-300). Several published randomised controlled trials have assessed the clinical effectiveness of Gla-300, mostly versus insulin glargine 100 U/mL as well as insulin degludec. However, there is limited information about the real-world effectiveness of Gla-300 when patients are transitioned directly from neutral protamine Hagedorn (NPH) human basal insulin. The primary objective of this study was to evaluate the effectiveness of Gla-300, defined as the percentage of participants with an HbA1c reduction of ≥0.5%, 6 months after switching from NPH insulin, in participants with T2DM. Secondary objectives included the safety assessment based on the percentage of patients experiencing ≥1 episodes and the number of hypoglycaemic episodes by category: severe, symptomatic, symptomatic confirmed, diurnal or nocturnal, change in body weight, and insulin dose. A total of 469 participants completed the 6-month observation period. Mean baseline HbA1c was 9.19%. The percentage of participants with a ≥0.5% improvement in HbA1c from baseline was 71.7% at 6 months. Mean HbA1c decreased at 3 and 6 months by 0.77% (±0.98) and 1.01% (±1.12), respectively (p < 0.00001 versus baseline), while fasting glycaemia decreased by 32 mg/dL and 37 mg/dL, respectively (p < 0.00001 versus baseline). There were moderate increases in the doses of both Gla-300 and, if used, short-acting insulins during the 6 months of observation. The percentage of participants with ≥1 hypoglycaemia event during the preceding 4 weeks decreased significantly from baseline to 3 and 6 months, as did the proportion with symptomatic hypoglycaemia at night (p < 0.00001 versus baseline). No participants had severe hypoglycaemia after a switch to Gla-300. Body mass, waist and hip circumferences, and waist : hip ratio did not change significantly. In conclusion, this large, prospective, observational study demonstrated that switching from NPH insulin to Gla-300 resulted in a significant improvement in HbA1c, with only a moderate increase in insulin dose, a decreased risk of hypoglycaemia, and no increase in body weight.

Combined continuous glucose monitoring and subcutaneous insulin infusion versus self-monitoring of blood glucose with optimized multiple injections in people with type 1 diabetes: A randomized crossover trial.

To investigate the efficacy of a combination of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) versus an optimized degludec-based multiple daily injections (MDI) regimen + self-monitoring of blood glucose (SMBG) in people with type 1 diabetes with regard to optimizing glucose control. The trial included 28 individuals who underwent a 4-week run-in phase, and were then randomized 1:1 to: (a) CSII + CGM followed by MDI + SMBG or (b) an MDI basal-bolus regimen followed by CSII + CGM. In patients randomized to the CSII + CGM → MDI + SMBG arm, a significant reduction in glycated haemoglobin (HbA1c) versus baseline was found at the end of the first phase (CSII + CGM) without significant variation in the following MDI + SMBG phase. In the arm randomized to the MDI + SMBG → CSII + CGM sequence, a significant improvement in HbA1c was observed in the first phase (MDI + SMBG), together with a further decrease in the following CSII + CGM phase. In the comparison of the two treatments using a mixed linear model, CSII + CGM was superior to MDI + SMBG with respect to change in HbA1c (P = 0.001). This study suggests that CSII + CGM improves glycaemic control without relevant safety issues in type 1 diabetes, in comparison with MDI + SMBG.

Two clinical cases of adjunctive use of a SGLT-2 inhibitor in type 1 diabetes

Type 1 diabetes mellitus (T1DM) prevalence is increasing and despite all available modern treatment options, an overall small but noticeable increase of mean HbA1c was recently observed in various registries. Authorized adjunctive pharmacological treatment options to insulin therapy are still scarce for T1DM. In February 2019, the European Medicines Agency (EMA) approved dapagliflozin as first in class sodium/glucose co-transporter 2 inhibitor (SGLT-2i) adjunctive therapy to insulin in patients with T1DM, which is currently still not approved by the FDA in the United States. SGLT-2is have shown significant improvement in HbA1c, reducing body weight and increasing time-in-range by reducing glycaemic variability, as well as reductions in total daily insulin dose in the trials in persons with T1DM. The cases presented here translate some of the observations gained from clinical trials into a real-world environment. They demonstrate that even highly practised and educated patients can benefit from the addition of a SGLT-2i as adjunctive treatment to insulin in T1DM. In summary, these cases demonstrate that a variety of patients with T1DM in a real-world setting may benefit from SGLT-2i treatment, as they have the potential to improve HbA1c, excess of body weight and increasing TiR among other things.

Effects and feasibility of a prehabilitation programme incorporating a low-carbohydrate, high-fat dietary approach in patients with type 2 diabetes: A retrospective study

Background and AimsWe performed a retrospective study of diabetic patients undergoing a targeted multimodal prehabilitation programme to assess changes in their diabetic control and functional capacity prior to surgery. As part of the programme, patients were encouraged to follow a low-carbohydrate, high-fat (LCHF) dietary approach. We aimed to assess the feasibility and effects of this programme on our cohort of patients. MethodsFrom 79 patients attending prehabilitation, 17 (13 males, age (median [interquartile range]): 71 [63–79] years) had Type 2 diabetes and none had Type 1. Patients had undergone a targeted multimodal prehabilitation programme prior to surgery, which comprised supervised exercise sessions (aerobic or resistance training), nutritional education (LCHF suggestion, correct protein intake, and avoidance of processed food), psychological support and medical optimization. Weight, body mass index (BMI), glycosylated haemoglobin (HbA1c), fasting glucose, and functional capacity were measured prior to and after prehabilitation. Data were compared with a Wilcoxon signed-rank test. ResultsThere were significant improvements in HbA1c (P = 0.000), fasting glucose (P = 0.006), weight (P = 0.002), and BMI (P = 0.002). There were no significant improvements in functional capacity. ConclusionsWe have shown that in the preoperative period, a targeted multimodal prehabilitation programme incorporating a LCHF diet improves diabetes control in patients with T2D awaiting elective surgery. Our approach is novel as a LCHF diet has not previously been utilized in patients with diabetes within this context. Prospective studies are required in the context of post-operative outcomes.

Beneficial Effects of Ipragliflozin on the Renal Function and Serum Uric Acid Levels in Japanese Patients with Type 2 Diabetes: A Randomized, 12-week, Open-label, Active-controlled Trial.

Objective To examine the add-on effects, compared to the existing antidiabetes treatment, of the sodium-glucose cotransporter 2 inhibitor ipragliflozin on glycemic control and the risk factors of cardiovascular disease (CVD) and chronic kidney disease (CKD) in patients with inadequately controlled type 2 diabetes. Methods This 12-week, randomized, open-label, active-controlled trial included 30 patients with type 2 diabetes who were randomized 1:1 to ipragliflozin and control groups (n=15 each). The ipragliflozin group received 50 mg of ipragliflozin once daily in addition to conventional therapy. The primary outcome was the change in hemoglobin A1c (HbA1c) from the baseline. Secondary outcomes were changes from the baseline in indices of glycemic control, uric acid (UA), renal function, and arterial stiffness. Results The patients' diminished estimated glomerular filtration rate (eGFR) was alleviated in the ipragliflozin group compared to the control group [difference between groups (Δ)=4.6 (95% confidence interval (CI): 1.5-7.7) mL/min/1.73 m2, p=0.006] prior to significant improvements in HbA1c and other parameters, including anthropometric indices and arterial stiffness. Furthermore, ipragliflozin add-on therapy resulted in a greater reduction in serum UA levels than control therapy [Δ=-52.3 (95% CI: -85.5-19.1) μmol/L, p=0.003]. The changes in the eGFR with ipragliflozin treatment were associated with ipragliflozin-mediated changes in the UA, even after adjusting for the age, sex, baseline HbA1c, baseline UA, and baseline eGFR (standardized regression coefficient=-0.535, p=0.010). Conclusion Ipragliflozin add-on therapy was associated with beneficial renal effects in parallel with reducing serum UA levels.

Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.

AimsThis real‐world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180‐day Eversense CGM System (Eversense) in patients with type 1 diabetes.Materials and methodsThis was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes‐care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70–180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery.ResultsOne‐hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty‐six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (−0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM‐naïve patients achieved the greatest reduction in HbA1c (−0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear.ConclusionsReal‐world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).

Different Effects of Structured Education on Glycemic Control and Psychological Outcomes in Adolescent and Adult Patients with Type 1 Diabetes: A Systematic Review and Meta-Analysis.

Aim This systematic review aimed at investigating the effectiveness of structured education (SE) in improving glycemic control and psychological outcomes in adolescent and adult patients with type 1 diabetes. Methods Electronic databases (EMBASE, Medline, PubMed, and the Cochrane Library) and the reference lists of included studies were searched from the beginning of the database through April 2019. Randomized controlled trials comparing SE with a control condition and reporting a change in glycosylated hemoglobin (HbA1c) level were included. The primary outcome was glycemic control measured by HbA1c. Secondary outcomes were diabetes-related distress, well-being, depression, and quality of life. Results Eighteen studies representing 2759 patients were included. Twelve studies targeted adolescents and six targeted adults. Adolescent patients who were randomized to the intervention group did not show significant improvement of HbA1c in the short (SMD = −0.04; 95% CI: −0.14 to 0.06; P=0.41), medium (SMD = −0.03; 95% CI: −0.13 to 0.07; P=0.41), medium (SMD = −0.03; 95% CI: −0.13 to 0.07; P=0.41), medium (SMD = −0.03; 95% CI: −0.13 to 0.07; P=0.41), medium (SMD = −0.03; 95% CI: −0.13 to 0.07; P=0.41), medium (SMD = −0.03; 95% CI: −0.13 to 0.07; Conclusions Development of more efficient SE programs according to the patients' personal characteristics is needed.

Evaluating the Impact of Year-Long, Augmented Diabetes Self-Management Support.

This was a randomized controlled study to test a scalable intervention model addressing the need for ongoing diabetes support. The study included individuals receiving care in a Federally Qualified Health Center (FQHC) with HbA1c >8. The aim of this project was to determine whether augmenting diabetes self-management education (DSME) with support for an economically vulnerable population might better meet patient needs and reduce morbidity and premature mortality. The intervention utilized pre and post comparisons and was designed to test the efficacy of a telephonic diabetes support intervention to increase patient engagement in self-care and with the health care system as a means to improve clinical outcomes. There were significant improvements in HbA1c, body mass index, low-density lipoprotein cholesterol, triglycerides, and depression screening scores in the year following DSME. However, there was no statistically significant difference between the 2 groups. This randomized controlled study demonstrated that comprehensive face-to-face care with consistent assessment and documentation over time in FQHCs produce clinically significant and predictable improvement for people with diabetes. The addition of structured provision of telephonic support overlapping in time with the comprehensive face-to-face process of care in this environment did not produce statistically significant clinical or behavioral care improvement.

Dulaglutide as an Add-on to Insulin in Type 2 Diabetes; Clinical Efficacy and Parameters Affecting the Response in Real-World Practice.

PurposeFor patients with type 2 diabetes (T2DM) who remain above their glycemic target on insulin therapy, a combination of insulin and a glucagon-like peptide 1 receptor agonist has been recommended. However, few studies have been conducted to determine the clinical efficacy and parameters affecting the response to this combination in a real-world setting. This study aimed to investigate the clinical efficacy and parameters affecting the glycemic response to dulaglutide as an add-on to insulin therapy for T2DM in a real-world clinical setting.Patients and methodsA retrospective study was performed in 120 patients with T2DM who had initiated dulaglutide as an add-on to insulin therapy between January 2017 and December 2018. After 6 months of treatment, the change in glycated hemoglobin (HbA1c) was evaluated. Multiple linear regression analysis was used to determine the parameters affecting the therapeutic response to dulaglutide.ResultsThe mean age of the patients was 55.1 years and 57.5% were male. The mean baseline HbA1c, body mass index, and duration of diabetes were 9.1%, 27.5 kg/m2, and 17.2 years, respectively. The change in HbA1c between baseline and 6 months was −0.97% (95% confidence interval [CI]: −1.28 to −0.66%, P<0.001), the change in body weight was −2.05 kg (95% CI: −2.93 to −1.17 kg, P<0.001), and the change in total daily insulin dose was −11.67 IU (95% CI: −14.55 to −8.78 IU, P<0.001). In multiple linear regression analysis, higher baseline HbA1c was associated with a greater reduction in HbA1c. The most frequent adverse events were gastrointestinal symptoms, but these were well-tolerated.ConclusionDulaglutide treatment in combination with insulin resulted in a significant improvement in HbA1c and body weight over a 6-month period in a real-world clinical setting. Higher baseline HbA1c was associated with a good clinical response.

Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin.

AimsTo assess whether people with type 2 diabetes transferring from higher basal insulin doses (> 20 units) to a starting dose of 16 units of insulin degludec/liraglutide (IDegLira) benefit from IDegLira with/without transient loss of glycaemic control.Methods Post hoc analysis of DUAL V and VII assessed fasting self‐measured blood glucose (SMBG) over weeks 1–8, changes in HbA1c, body weight and mean insulin dose over 26 weeks, and percentage of participants achieving HbA1c < 53 mmol/mol (7.0%) by end of trial in participants with type 2 diabetes uncontrolled with basal insulin. IDegLira was compared with continued up‐titration of insulin glargine (IGlar U100) in DUAL V, or switching to basal–bolus therapy in DUAL VII (IGlar U100 and insulin aspart), across pre‐trial insulin dose groups (20–29, 30–39 and 40–50 units/day).ResultsIn all subgroups, participants treated with IDegLira experienced significant improvements in HbA1c by end of trial, which were greater than with IGlar U100 up‐titration (estimated treatment difference –5.86, –6.59 and –6.91 mmol/mol for pre‐trial insulin doses of 20–29, 30–39 and 40–50 units/day, respectively) and similar to basal–bolus therapy (estimated treatment difference –0.16, –1.0 and –0.01 mmol/mol for pre‐trial insulin doses of 20–29, 30–39 and 40–50 units/day, respectively). Compared with IGlar U100 and basal–bolus therapy, IDegLira participants experienced weight loss vs. weight gain, lower rates of hypoglycaemia and a lower mean end of trial total daily insulin dose. In both trials, mean fasting SMBG decreased from weeks 1 to 8 across all subgroups, despite a temporary increase in mean fasting SMBG in the 40–50 units pre‐trial insulin dose group during week 1 [mean increase (sd) +1.1 (2.0) mmol/l for DUAL V and +1.1 (2.1) mmol/l for DUAL VII], which reverted to baseline by week 4.ConclusionsRegardless of pre‐trial insulin dose, IDegLira resulted in improved clinical outcomes, even in participants transferring from 40–50 units of basal insulin, despite a transient (< 4 weeks), clinically non‐relevant, elevation in pre‐breakfast SMBG. (Clinical Trial Registry Number NCT01952145 and NCT02420262).

A Virtual Type 2 Diabetes Clinic Using Continuous Glucose Monitoring and Endocrinology Visits.

The Onduo Virtual Diabetes Clinic (VDC) telehealth technology/care model for adults with type 2 diabetes (T2D) combines connected devices, remote lifestyle coaching, and clinical support with a mobile App. Key differentiating program features are the availability of live video consultations with board-certified endocrinologists for medication management and real-time continuous glucose monitor use for higher-risk participants. Preliminary data (n = 740) suggest that participation was associated with a significant improvement in HbA1c with up to 6 months follow-up in those not meeting treatment targets. HbA1c decreased by 2.3% ± 1.9%, 0.7% ± 1.0%, and 0.2% ± 0.8% across baseline categories of >9.0%, 8.0%-9.0% and 7.0% to <8.0%, respectively (all P < .001). These findings suggest that the VDC has potential to support individuals with T2D and their clinicians in diabetes management between office visits.

Flash glucose monitoring: Impact on markers of glycaemic control and patient-reported outcomes in individuals with type 1 diabetes mellitus in the real-world setting

AimsWe aimed to evaluate both glycaemic parameters and patient-reported outcomes in patients prescribed FGM based on the local criteria at our institution. MethodsThis retrospective observational study included patients aged > 18 years with a diagnosis of type 1 diabetes mellitus (T1DM) who were prescribed FreeStyle Libre FGM (n = 90). Quantitative data on glycaemic parameters was collected pre- and post-initiation of FGM in addition to patient-reported outcome measures (PROMs). The primary outcome was change in pre- and post-FGM levels of glycosylated haemoglobin (HbA1C). ResultsThere was a mean reduction in HbA1c of −7.29 ± 10.76 mmol/mol (p < 0.001, CI95% 4.94–9.64) sustained to the latest reading. There was also a mean reduction in the number of hypoglycaemic episodes per week of 3.20 (percentage reduction 51.86%, p < 0.001, CI95% 1.64–4.77). A significant improvement in quality of life scores was noted in all five domains of the abbreviated DDS between before and after starting FGM (p < 0.001). Key themes highlighted in inductive content analysis include ‘life-changing’, ‘positive experience’, and ‘convenient’. ConclusionFlash glucose monitoring is associated with significant improvement in HbA1c to a mean follow-up of 4.6 months. Additionally, patients reported positive experiences of FGM with significant improvement in all aspects of a focussed Diabetes Distress Scale.

Participation in a Virtual Diabetes Clinic Improves Glycemic Control in Adults with Type 2 Diabetes

Background Telemedicine for people with type 2 diabetes (T2D) has the potential to positively impact self-management behaviors and improve health outcomes. The Onduo Virtual Diabetes Clinic (VDC) is a comprehensive telehealth program for people with T2D that combines mobile app technology, remote personalized lifestyle coaching from certified diabetes educators and health coaches, connected devices including blood glucose meters and continuous glucose monitoring systems, and clinical support from board certified endocrinologists. Objective To describe the VDC care delivery model and present preliminary data on change in glycemic control in program participants with up to 6 months of follow-up. Methods Adults ≥18 years of age with T2D and who were members of sponsoring health plans and employers throughout the US were eligible to participate. Those who elected to enroll downloaded the VDC app to their smartphone, provided demographic and clinical information, completed an onboarding survey, and were mailed a self-management kit that included a connected blood glucose meter, test strips and a home glycosylated hemoglobin (HbA1c) testing kit. Participants interacted with their care team primarily through the VDC app, with occasional phone calls, and by synchronous video consultations with endocrinologists, as clinically appropriate. Change in glycemic control in participants who completed a baseline survey from February 2018 through December 31, 2018, with an initial HbA1c measurement within 30 days of enrollment and a follow-up measurement between 90 and 180 days after baseline was analyzed. Results Participants (n=740) were (mean ± SD): 53.8 ± 8.8 years of age, 62% female, BMI 35.6 ± 8.5, initial HbA1c 7.7% ± 1.8, 31.0% were on insulin and 25.9% were on sulfonylureas at baseline, and 30.0% lived in a rural area. HbA1c decreased significantly by 2.3% ± 1.9, 0.7% ± 1.0 and 0.2% ± 0.8 across the baseline categories of &gt;9.0%, 8.0% to 9.0% and 7.0% to &lt;8.0%, respectively (all P&lt;.001). Within these categories, HbA1c improved in 91.9%, 77.3% and 63.5% of participants. For the group with an initial HbA1c &gt;9.0%, HbA1c decreased from 10.7% ± 1.4 to 8.3% ± 1.5, and when stratified by HbA1c ≥8.0% the mean decrease in HbA1c was 1.5%, from 9.5% ± 1.5 to 8.0% ± 1.3, with 84.5% of participants demonstrating improvement. Participants with an initial HbA1c &lt;7.0% who were meeting treatment targets at baseline, HbA1c 6.3% ± 0.4, continued to maintain this level of glycemic control at follow-up, HbA1c 6.4% ± 0.6 (ns). Conclusions Participation in the VDC was associated with a significant improvement in HbA1c in adults with T2D who were not meeting treatment targets, with the greatest improvement observed in those with an initial HbA1c &gt;9.0%. Importantly, the majority of program participants experienced an improvement in glycemic control. Our findings suggest that the VDC program is an effective approach to support individuals with T2D and their clinicians in diabetes management between office visits.

Impact and Cost-Effectiveness of Integrated Psychology Services in a Pediatric Endocrinology Clinic

Including psychology services in pediatric endocrinology clinics may improve patients' adherence to diabetes management behaviors, and, subsequently, glycemic control; however, an evaluation ofthe impact and cost-effectiveness of this integration is needed. The change in HbA1c and cost-effectiveness of integrated psychology services, from the hospital and insurance provider perspectives, were evaluated using a linear effects model and Incremental Cost-Effectiveness Ratios (ICERs). Data from 378 patients with T1D (50% female; 65% Caucasian; M age = 12.0years) were obtained via medical chart review (2241 appointments). Patients demonstrated significant improvements in HbA1c following clinic visits in which they met with psychology (b = - 0.16, p = 0.006). A larger proportion of the distribution of ICER values fall below the $1000/1% HbA1c threshold from both the insurance (89%) and hospital (94%) perspectives. These results indicate that providing integrated psychology services in the endocrinology clinic is highly beneficial from the patient, hospital, and insurance provider perspectives.

Obesity in older adults: Effect of degree of weight loss on cardiovascular markers and medications.

Obesity worsens the age-related tendency towards cardiovascular disease and diabetes. Older adults are vulnerable to medication adverse effects. Intentional weight loss in older adults with obesity has been shown to improve cardiovascular and glycaemic markers. The effect of rapid weight loss induced by very-low-calorie diets (VLCDs) on these markers has not been evaluated in this group. In this 12-week study, participants were randomized to one of healthy eating, hypocaloric diet or VLCD, all combined with three times weekly exercise (Ex/HE, Ex/Diet, Ex/VLCD, respectively). The effects of these interventions on weight, blood pressure, lipids, glucose and HbA1c , inflammatory markers and cardiovascular and diabetes medication changes were measured. Weight loss was 3.7%, 5.1% and 11.1% in Ex/HE, Ex/Diet and Ex/VLCD, respectively. There were significant improvements in HbA1c in all groups, but by the greatest degree in Ex/VLCD (0.18 ± 0.07%, 0.18 ± 0.06% and 0.59 ± 0.13%, respectively). Similar patterns were seen in total cholesterol (0.13 ± 0.15, 0.21 ± 0.11 and 0.53 ± 0.13 mmol/L, respectively, P = .047), triglycerides (0.35 ± 0.13, 0.20 ± 0.10 and 0.51 ± 0.09 mmol/L, respectively, P = .011) and systolic blood pressure (9 ± 2, 2 ± 3 and 14 ± 3 mmHg respectively, P = .025). There were no between-group differences in fasting glucose, high-density lipoprotein (HDL) cholesterol, LDL-C and inflammatory markers. Reductions in anti-hypertensive or diabetes medication were made in 4/29, 7/36 and 16/37 participants in Ex/HE, Ex/Diet and Ex/VLCD, respectively (P = .017). Significant weight loss achieved with a VLCD gave rise to improvements in multiple cardiovascular risk markers, despite reduction in medication. Weight loss is an under-utilized method of cardiovascular risk management in this group.

Marked improvement in HbA1c following commencement of flash glucose monitoring in people with type 1 diabetes

Aims/hypothesisMinimal evidence supports the efficacy of flash monitoring in lowering HbA1c. We sought to assess the impact of introducing flash monitoring in our centre.MethodsWe undertook a prospective observational study to assess change in HbA1c in 900 individuals with type 1 diabetes following flash monitoring (comparator group of 518 with no flash monitoring). Secondary outcomes included changes in hypoglycaemia, quality of life, flash monitoring data and hospital admissions.ResultsThose with baseline HbA1c ≥58 mmol/mol (7.5%) achieved a median −7 mmol/mol (interquartile range [IQR] −13 to −1) (0.6% [−1.2 to −0.1]%) change in HbA1c (p < 0.001). The percentage achieving HbA1c <58 mmol/mol rose from 34.2% to 50.9% (p < 0.001). Median follow-up was 245 days (IQR 182 to 330). Individuals not using flash monitoring experienced no change in HbA1c across a similar timescale (p = 0.508). Higher HbA1c (p < 0.001), younger age at diagnosis (p = 0.003) and lower social deprivation (p = 0.024) were independently associated with an HbA1c fall of ≥5 mmol/mol (0.5%). More symptomatic (OR 1.9, p < 0.001) and asymptomatic (OR 1.4, p < 0.001) hypoglycaemia was reported after flash monitoring. Following flash monitoring, regimen-related and emotional components of the diabetes distress scale improved although the proportion with elevated anxiety (OR 1.2, p = 0.028) and depression (OR 2.0, p < 0.001) scores increased. Blood glucose test strip use fell from 3.8 to 0.6 per day (p < 0.001). Diabetic ketoacidosis admissions fell significantly following flash monitoring (p = 0.043).Conclusions/interpretationFlash monitoring is associated with significant improvements in HbA1c and fewer diabetic ketoacidosis admissions. Higher rates of hypoglycaemia may relate to greater recognition of hitherto unrecognised events. Impact upon quality of life parameters was mixed but overall treatment satisfaction was overwhelmingly positive.