A Diabetes Mobile App With In-App Coaching From a Certified Diabetes Educator Reduces A1C for Individuals With Type 2 Diabetes.

The purpose of this study is to examine the long-term impact of a digital diabetes self-management education and support (DSMES) program on A1C among adults with type 2 diabetes (T2DM). Data analyzed were from a retrospective cohort of commercially insured members with T2DM enrolled in the Omada for Diabetes program between January 1, 2019, and January 31, 2022 (n = 1,322). Linear mixed models measured changes in A1C and weight across 12 months (collected at baseline and every 3 months over 1 year) overall and stratified by A1C at baseline (≥8% vs <8%). On average, members were 53.5 years old, 56.9% female, and 71.5% White, with a mean baseline body mass index (BMI) of 36.9 and A1C of 7.6%. Members with baseline A1C ≥8% demonstrated clinically and statistically significant adjusted mean reductions in A1C during follow-up, from 9.48% at baseline to 7.33%, 7.57%, 7.59%, and 7.47% at 3, 6, 9, and 12 months, respectively. Those with A1C <8% maintained glycemic stability (6.73%, 6.50%, 6.54%, 6.62%, and 6.51%, respectively). Collectively, members experienced a -1.17 kg/m2 mean reduction in BMI over 12 months. This study provides real-world evidence that members with elevated baseline A1C (≥8%) enrolled in a digital DSMES program experienced clinically meaningful and statistically significant reductions in A1C. Those with baseline A1C within goal treatment range (<8%) maintained glycemic stability over 1 year. The findings support existing evidence that scalable digital DSMES solutions can help individuals with T2DM manage their condition.

The purpose of this study was to assess the effectiveness of continued education and multiprofessional care for type 1 diabetes mellitus patients as a strategy for long-term glycemic control evaluated by glycosylated hemoglobin (A1C) levels. This study is a retrospective, observational study of the Diabetes Objective Control and Education (DOCE) Project. A group of 74 patients accompanied by family member attended multiprofessional appointments and an epidemiologic profile of the group was created. The analyzed variables were age, body mass index (BMI), height, duration of disease, age at diagnosis, duration of follow-up, current and baseline A1C, and the relationship between the period of follow-up and the variation in A1C. Mean age at diagnosis was 10.4±7.3 years, and duration of disease was 5.6±6.3 years. Mean age was 16±9.3 years, while mean BMI was 20.3±5.3. Mean duration of follow-up was 27.5±15.6 months. Baseline and current A1C were 10.5±1.8 and 8.2±1.7, respectively. A significant reduction in A1C was observed with the follow-up by the DOCE Project (p=0.00436). Other significant correlations were found between duration of treatment and reduction of current A1C (p=0.00000001) and duration follow-up and A1C reduction (p=0.00000003). Continued education and multiprofessional care for type 1 diabetes mellitus patients is an effective method for long-term glycemic control. Key words: Diabetes mellitus, glycosylated hemoglobin (A1C), education, glycemic control.

Diabetes self-management education for adults with type 2 diabetes mellitus: A systematic review of the effect on glycemic control

BACKGROUNDGlycemic control is suboptimal in many individuals with type 2 diabetes. Although use of flash continuous glucose monitoring (CGM) has demonstrated A1C reductions in patients with type 2 diabetes treated with a multiple daily injection or insulin pump therapy regimen, the glycemic benefit of this technology in patients with type 2 diabetes using nonintensive treatment regimens has not been well studied.METHODSThis retrospective, observational study used the IBM Explorys database to assess changes in A1C after flash CGM prescription in a large population with suboptimally controlled type 2 diabetes treated with nonintensive therapy. Inclusion criteria were diagnosis of type 2 diabetes, age <65 years, treatment with basal insulin or noninsulin therapy, naive to any CGM, baseline A1C ≥8%, and a prescription for the FreeStyle Libre flash CGM system during the period between October 2017 and February 2020. Patients served as their own control subject.RESULTSA total of 1,034 adults with type 2 diabetes (mean age 51.6 ± 9.2 years, 50.9% male, baseline A1C 10.1 ± 1.7%) were assessed. More patients received noninsulin treatments (n = 728) than basal insulin therapy (n = 306). We observed a significant reduction in A1C within the full cohort: from 10.1 ± 1.7 to 8.6 ± 1.8%; Δ −1.5 ± 2.2% (P <0.001). The largest reductions were seen in patients with a baseline A1C ≥12.0% (n = 181, A1C reduction −3.7%, P <0.001). Significant reductions were seen in both treatment groups (basal insulin −1.1%, noninsulin −1.6%, both P <0.001).CONCLUSIONPrescription of the flash CGM system was associated with significant reductions in A1C in patients with type 2 diabetes treated with basal insulin or noninsulin therapy. These findings provide evidence for expanding access to flash CGM within the broader population of people with type 2 diabetes.

Long-Term Use of Omnipod® Insulin Management System Associated with Lower A1c in Adults with Established Diabetes and A1c =8%

Comparing SGLT-2 inhibitors to DPP-4 inhibitors as an add-on therapy to metformin in patients with type 2 diabetes: A systematic review and meta-analysis

The glucose management indicator (GMI) is an estimated glycated hemoglobin (A1C) derived from sensor glucose. Though it is being used to approximate A1C in clinical trials, there are no data on direction and magnitude of change in GMI vs A1C after an intervention. To evaluate the magnitude and direction of changes in A1C compared to GMI across different baseline glycemic categories in type 1 diabetes (T1D) clinical trials. Baseline and 3-month central laboratory-measured A1C and estimated GMI from sensor glucose were collected from T1D clinical trials (DCLP3, DCLP5, and WISDM), encompassing children, adolescents, adults, and older adults. Magnitude and direction of changes (baseline-3 months) in A1C vs GMI were compared overall across the studies and by stratified baseline A1C (<7%, 7%-9%, >9%). A modest correlation was found between changes in A1C and GMI (r = 0.34). Participants with baseline A1C > 9% had larger reductions in A1C compared to GMI (-1.2 [-2.1 to -0.6] vs -0.6 [-0.94 to 0], P < .01). Those with baseline A1C between 7% and 9% showed a greater decline in A1C than GMI (-0.4 [-0.9 to -0.1] vs -0.12 [-0.49 to 0.21], P < .01). No significant difference was observed for baseline A1C < 7%. Change in GMI is influenced by the baseline A1C of the participants and it underestimates the true change in A1C. Use of GMI as an endpoint in clinical trials may not reliably capture efficacy of an intervention in T1D trials or real-world studies.

738-P: Real-World Effectiveness among Patients with Type 2 Diabetes (T2D) Initiating Tirzepatide (TZP)

This study aimed to demonstrate the effectiveness of long-term use of intermittently scanned continuous glucose monitoring (isCGM) in adult patients with type 1 diabetes. In this retrospective real-world study, 689 patients with type 1 diabetes who were >18 years of age and using isCGM were identified from the electronic patient records in North Karelia, Finland. A1C data were collected before and after the initiation of isCGM. The primary outcome was a change in the mean A1C over time after isCGM started. The greatest reductions in the mean A1C levels were observed 6 months (-0.54% [-5.9 mmol/mol], P <0.001) and 12 months (-0.42% [-4.6 mmol/mol], P <0.001) after the initiation of isCGM. Reduction in A1C remained significant for 4 years, although the mean reduction in A1C was -0.18% (-2.05 mmol/mol) (P = 0.009) at 48 months compared with baseline. In a subgroup analysis, patients with a baseline A1C >9% (75 mmol/mol) benefited the most from initiation of isCGM (reduction -0.97% [-10.6 mmol/mol], P <0.001, at 12 months and -0.92% [-10.1 mmol/mol], P <0.001, at 48 months). Neither sex nor age at the start of isCGM were correlated with A1C reduction. Use of isCGM improves A1C levels significantly in adult patients with type 1 diabetes. Significant reduction in A1C persisted over 4 years of use, although the effect diminished over time.

The Specialist And Primary Physicians Health Initiative to Reduce Endpoints in Diabetes (SAPPHIRE) Study: A Novel Type 2 Diabetes Care Delivery Model to Improve Glycemic Control in Hong Kong

2381-PUB: Shared Medical Appointments: An Academic-Community Partnership to Improve Metabolic Outcomes among People with Type 2 Diabetes in the Central Valley of California

A cohort of patients with type 2 diabetes, prescribed glyburide/metformin tablets, experienced significantly greater improvements in glycaemic control compared to patients receiving glyburide co-administered with metformin. To compare the change in A1C for type 2 diabetic patients new to combination therapy with fixed-dose glyburide/metformin tablets vs. glyburide co-administered with metformin in a usual-care setting. This retrospective cohort study analysed medication usage via an administrative pharmacy claims database and the patients' corresponding laboratory results. Patients were new to antidiabetic combination therapy with glyburide/metformin tablets or glyburide co-administered with metformin between August 2000 and July 2001 and had A1C measurements at baseline and within 76-194 days of initiating combination therapy. The change from baseline in A1C was analysed using statistical regression to adjust for significant covariates (baseline A1C and dosage). Adherence with therapy was also compared. The cohort consisted of 950 patients who received glyburide/metformin tablets and 471 taking glyburide co-administered with metformin. Glyburide/metformin patients were younger (mean age = 56 vs. 60 years, p < 0.0001) and received lower doses of each drug than patients taking glyburide co-administered with metformin (glyburide mean final dose = 6 vs. 10 mg/day, p < 0.0001; metformin = 893 vs. 1297 mg/day, p < 0.0001). The mean decrease from baseline A1C, adjusted for baseline A1C and dosage, of 2.02% for glyburide/metformin tablets was significantly (p < 0.0001) greater than the decrease of 1.49% for glyburide co-administered with metformin. Glyburide/metformin patients with baseline A1C >/= 8 experienced a significantly (p < 0.0001) greater decrease in A1C of 2.93% compared to 1.92% for glyburide co-administered with metformin. For patients with baseline A1C < 8%, the difference between the A1C responses remained significant, even though the reductions in A1C were smaller for both glyburide/metformin tablets and glyburide co-administered with metformin (0.54% and 0.23%, p = 0.0017). Patients were more adherent with glyburide/metformin tablets (84% vs. 76%, p < 0.0001), though regression analysis indicated that adherence was not a significant predictor of change in A1C. The lower medication doses delivered by glyburide/metformin tablets provided a significantly greater reduction in A1C than did glyburide co-administered with metformin in patients with type 2 diabetes, especially when baseline A1C >/= 8%.

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.

1208-P: Empagliflozin and HbA1c Reduction in a National Cohort

ObjectiveTo identify patient factors associated with change in hemoglobin A1C (A1C) with adjunct pioglitazone therapy in routine clinical practice.MethodsThis was a retrospective analysis of adult type 2 diabetes mellitus patients in a health maintenance organization setting who were newly-initiated on pioglitazone between January 2002 and December 2005. Eligible patients were receiving at least one other oral antihyperglycemic medication prior to initiating pioglitazone and maintained a stable dose of pioglitazone for 90 days. Data on eligible patients’ characteristics, pharmacy purchases, comorbidities, and A1C measurement 90 days prior to the pioglitazone purchase date (baseline) and 90 days after achieving a stable dose (follow-up) were obtained from electronic records. Multivariate regression modeling was used to assess factors independently associated with: 1) absolute change in A1C, 2) achieving a ≥1 percentage point decrease in A1C, and 3) achieving an A1C<7%.ResultsBaseline and follow-up A1Cs were available for 128 patients. At baseline, mean age was 65 years, 38% were female, mean A1C was 8.4%, and 74% had an A1C>8%. At follow-up, the mean A1C change was -1.2 percentage points (interquartile range= -0.4, -2.1), 59% achieved a ≥1 unit decrease in A1C, and 44% achieved an A1C<7%. Independent predictors in all models were baseline A1C and time (in days) between baseline and follow-up A1C measurements (p<0.05).ConclusionsAdjunct pioglitazone therapy in routine clinical practice was associated with clinically meaningful reductions in A1C levels. Patients with higher baseline A1C achieved the greatest absolute reduction in A1C but were less likely to achieve levels <7%.