Randomized comparison of self-monitored blood glucose (BGM) versus continuous glucose monitoring (CGM) data to optimize glucose control in type 2 diabetes.

Aims: Evaluate whether structured BGM testing (BGM) or real-time CGM (CGM) lead to improved glucose control (A1c). Determine which approach optimized glucose control more effectively. METHODS-MULTI-ARM PARALLEL: trial of three type 2 diabetes (T2D) therapies ± metformin: (1) sulfonylurea (SU), (2) incretin (DPP4 inhibitor or GLP-1 agonist), or (3) insulin.

EVALUATION OF INSULIN GLARGINE AND EXENATIDE ALONE AND IN COMBINATION: A RANDOMIZED CLINICAL TRIAL WITH CONTINUOUS GLUCOSE MONITORING AND AMBULATORY GLUCOSE PROFILE ANALYSIS.

Characterize the effectiveness of insulin glargine alone, exenatide alone, or combined in subjects taking stable doses of metformin and evaluate their impact on hemoglobin A1C, hypoglycemia, weight, and glucose variability. Open-label, randomized, parallel-arm study of adults with type 2 diabetes naïve to both insulin and glucagon-like peptide 1 (GLP-1) agonist who were not at A1C goal despite treatment with metformin. This prospective interventional study employed blinded continuous glucose monitoring ambulatory glucose profile (AGP) reports over 32 weeks.

Technology Applications: Use of Digital Health Technology to Enable Drug Development.

Purpose: This pilot study developed and evaluated the feasibility, usability, and perceived satisfaction with an end-user mobile medical application and provider web portal. The two interfaces allowed for remote monitoring, provided daily guidance in the management of hypertension and diarrhea, and allowed for rapid management of adverse events during a clinical trial of olaparib and cediranib.

Patients And Methods: eCO (eCediranib/Olaparib) was designed for patient self-reported, real-time management of hypertension and diarrhea using remote monitoring.

Diurnal glucose exposure profiles of patients treated with lixisenatide before breakfast or the main meal of the day: An analysis using continuous glucose monitoring.

Background: In the parent study of this analysis, patients with type 2 diabetes received lixisenatide before breakfast or the main meal of the day. This substudy was designed to examine the effect of lixisenatide administered before breakfast or the main meal of the day on continuously assessed 24-hour patient glucose profiles.

Methods: A subset of patients from the parent study underwent 2 14-day periods of continuous glucose monitoring (CGM) at the start and end of the 24-week study.

Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes.

Objective: To determine whether insulin delivered via a 4-mm × 32-gauge pen needle (PN) provides equivalent glycemic control as 8-mm × 31-gauge and 12.7-mm × 29-gauge PNs in obese (body mass index ≥30) patients with diabetes.

Patients And Methods: This prospective, multicenter, randomized, open-label, 2-period, crossover, equivalence, home-based study was conducted from October 26, 2010, through May 31, 2012.

A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

Objective: This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D).

Research Design And Methods: Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed.

Diurnal glucose profiles using continuous glucose monitoring to identify the glucose-lowering characteristics of colesevelam HCl (Welchol).

Objectives: The study's purpose was to identify the antihyperglycemic affects of colesevelam-HCl (C-HCl) by characterizing the diurnal and postprandial glucose patterns in type 2 diabetic subjects treated concomitantly with metformin, sulfonylurea, or a combination of metformin/sulfonylurea. A secondary aim was to determine whether C-HCl significantly increased the risk of hypoglycemia.

Methods: A prospective, randomized, double-blind, placebo-controlled, crossover study employing continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis was undertaken.

Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the ambulatory glucose profile.

Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic control among individuals with type 1 diabetes mellitus. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardizing the analysis and presentation of glucose monitoring data, with the initial focus on data derived from continuous glucose monitoring systems. The panel members were introduced to a universal software report, the Ambulatory Glucose Profile, and asked to provide feedback on its content and functionality, both as a research tool and in clinical settings.

International Forum for the Advancement of Diabetes Research and Care, April 29-30, 2011, Athens, Greece.

The International Forum for the Advancement of Diabetes Research and Care brought together distinguished international experts in diabetes to discuss diverse trends and emerging issues in diabetes therapy and management. The plenary sessions on the first day focused on trends in insulin therapy, the role of glucagon-like peptide-1 receptor agonists in diabetes treatment, the relationship between diabetes and cardiovascular risk, and the challenges associated with the development of clinically relevant treatment guidelines. Interactive breakout sessions addressed the following topics: microvascular complications of diabetes; the need for a team approach to patient education; optimal management of Asian people with diabetes; the role of continuous glucose monitoring in assessing glucose variability; and lessons learned from biosimilar drugs.

Diurnal glucose patterns of exenatide once weekly: a 1-year study using continuous glucose monitoring with ambulatory glucose profile analysis.

Objective: To use continuous glucose monitoring (CGM) to characterize diurnal glucose patterns produced by a novel formulation of exenatide consisting of biodegradable polymeric microspheres that entrap exenatide and provide extended release enabling once-weekly administration.

Methods: We performed a subgroup analysis of patients with type 2 diabetes who participated in a multicenter trial (DURATION-1: Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus) comparing once-weekly with twice-daily formulations of exenatide. We are the only center to use CGM with ambulatory glucose profile (AGP) analysis to characterize glucose exposure, variability, and stability in participants assigned to exenatide once weekly.

Evaluating the accuracy, reliability, and clinical applicability of continuous glucose monitoring (CGM): Is CGM ready for real time?

Background: This study was designed to assess the accuracy, reliability, and contribution to clinical decision-making of two commercially available continuous glucose monitoring (CGM) devices using a novel analytical approach.

Study Design: Eleven individuals with type 1 diabetes and five with type 2 diabetes wore a Guardian RT (GRT) (Medtronic Minimed, Northridge, CA) or DexCom STS Continuous Monitoring System (DEX) (San Diego, CA) device for 200 h followed by an 8-h laboratory study. A subset of these subjects wore both devices simultaneously.

Characterizing glucose exposure for individuals with normal glucose tolerance using continuous glucose monitoring and ambulatory glucose profile analysis.

Background: Efforts to mimic euglycemia depend upon targets from epidemiologic studies that rely on episodic measurements reduced to statistical summaries, leaving open the question, "What is normal glycemia?" We postulated that portrayal of euglycemia was possible through application of continuous glucose monitoring (CGM) and a novel analytical tool, the ambulatory glucose profile (AGP).

Methods: Individuals with normal glucose tolerance (NGT) and with diabetes used CGM for 30 days. AGP analysis, which graphs CGM data by time without regard to date, was used to characterize glucose exposure, variability, and stability.