EMBARK: A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA1c in Adults With Type 1 Diabetes.

OBJECTIVE: To compare the effectiveness of three interventions to reduce diabetes distress (DD) and improve HbA1c among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Individuals with T1D (n = 276) with elevated DD (a score >2 on the total Type 1 Diabetes Distress Scale) and HbA1c (>7.5%) were recruited from multiple settings and randomly assigned to one of three virtual group-based programs: 1) Streamline, an educator-led education and diabetes self-management program; 2) TunedIn, a psychologist-led program focused exclusively on emotional-focused DD reduction; or 3) FixIt, an integration of Streamline and TunedIn. Assessments of the primary outcomes of DD and HbA1c occurred at baseline and at 3, 6, and 12 months. RESULTS: All three programs demonstrated substantive and sustained reductions in DD (Cohen's d = 0.58-1.14) and HbA1c (range, -0.4 to -0.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared with Streamline participants (P = 0.007). Streamline and TunedIn participants achieved significantly greater HbA1c reductions than did FixIt participants (P = 0.006). CONCLUSIONS: DD can be successfully reduced among individuals with T1D with elevated HbA1c using both the educational/behavioral and emotion-focused approaches included in the study. Although both approaches are associated with significant and clinically meaningful reductions in DD and HbA1c, TunedIn, the emotion-focused program, had the most consistent benefits across both DD and HbA1c. The study findings suggest the overall value of group-based, fully virtual, and time-limited emotion-focused strategies, like those used in TunedIn, for adults with T1D.

All Children Deserve to Be Safe, Mothers Too: Evidence and Rationale Supporting CGM Use in Gestational Diabetes Within the Medicaid Population.

Gestational diabetes mellitus (GDM) is a common metabolic disease of pregnancy that threatens the health of several million women and their offspring. The highest prevalence of GDM is seen in women of low socioeconomic status. Women with GDM are at increased risk of adverse maternal outcomes, including increased rates of Cesarean section delivery, preeclampsia, perineal tears, and postpartum hemorrhage. However, of even greater concern is the increased risk to the fetus and long-term health of the child due to elevated glycemia during pregnancy. Although the use of continuous glucose monitoring (CGM) has been shown to reduce the incidence of maternal and fetal complications in pregnant women with type 1 diabetes and type 2 diabetes, most state Medicaid programs do not cover CGM for women with GDM. This article reviews current statistics relevant to the incidence and costs of GDM among Medicaid beneficiaries, summarizes key findings from pregnancy studies using CGM, and presents a rationale for expanding and standardizing CGM coverage for GDM within state Medicaid populations.

Impact of Medicare Continuous Subcutaneous Insulin Infusion Policies in Patients With Type 1 Diabetes.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) has numerous requirements for coverage of continuous subcutaneous insulin infusion (CSII; insulin pump). Due to recent improvements in diabetes treatment, people with type 1 diabetes are living longer, resulting in an increase in the number of individuals who are eligible for Medicare and are impacted by CMS policies regarding CSII. METHODS: Two hundred forty-one adults with type 1 diabetes who had been on CSII with CMS coverage for at least 6 months were surveyed. Median age was 67 years, mean A1c was 7.0%, 64% were women, 93% were white, and the median type 1 diabetes duration was 42 years. Participants reported median CSII use of 15 years and 82% were on CSII before starting CMS. RESULTS: Of those starting CSII while on CMS, challenges included cost of supplies (29%) or the insulin pump (24%). The majority (57.5%) reported issues with obtaining supplies, the most common problems being delays in release of supplies (29%), difficulty getting paperwork completed (23.5%), and seeing a health care provider every 90 days (18%). Participants reported changing their CSII behaviors because of supply delays (39%) including leaving site in place >3 days (64%), and reusing pump supplies (34%). Consequently, participants reported adverse outcomes including more erratic (48%) or higher (42%) blood glucose and pain or irritation at sites (34%). CONCLUSION: This study concluded that current CMS CSII policies promote adverse CSII behaviors and outcomes in type 1 diabetes and thus call for changes in the CMS CSII policies.

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring.

Two types of continuous glucose monitoring (CGM) systems are now available: real-time CGM (rtCGM) and intermittently scanned (isCGM). Current rtCGM systems automatically transmit a continuous stream of glucose data to the user, provide alerts and active alarms, and transmit glucose data (trend and numerical) in real time to a receiver, smart watch, or smartphone. The current isCGM system provides the same type of glucose data but requires the user to purposely scan the sensor to obtain information, and it does not have alerts and alarms. Both CGM technologies have significant advantages over self-monitoring of blood glucose; however, differences in the features and capabilities of the two approaches must be considered when guiding patient selection of the system that meets their individual needs.

FLASH GLUCOSE MONITORING: A PATIENT'S AND CLINICIAN'S CAVEATS AND CONCERNS.

ABBREVIATIONS: CGM = continuous glucose monitor; FDA = U.S. Food and Drug Administration; iCGM = intermittently scanned CGM; MBG = mean blood glucose; rtCGM = real-time CGM; T1D = type 1 diabetes.

Practical Considerations on the Use of Continuous Glucose Monitoring in Pediatrics and Older Adults and Nonadjunctive Use.

Clinical use of continuous glucose monitoring (CGM) devices has grown over the past 15 years from a niche concept to becoming standard of care for patients with type 1 diabetes (T1D). With the December 2016 Food and Drug Administration approval for diabetes treatment decisions directly from CGM values (nonadjunctive use) without finger-stick confirmation, the uptake and scope of CGM use will likely further expand. With this expansion, it is important to consider the role and impact of CGM technology in specific settings and high-risk populations, such as the young and the elderly. In pediatric patients, CGM concerns include limited body surface area, difficulty keeping sensors adhered, and the role of nonadjunctive use in the school setting. In older adults, Medicare did not, until very recently, cover CGM devices and as such, their use had been limited by lack of reimbursement. As CGM use will likely expand in clinical practice given the nonadjunctive indication, guidelines and recommendations for clinical practice are warranted. In this article, we discuss recent research on CGM use in the special populations of children and older adults and provide initial guidelines for nonadjunctive use in clinical practice.

GLYCEMIC EFFECTS OF SGLT-2 INHIBITOR CANAGLIFLOZIN IN TYPE 1 DIABETES PATIENTS USING THE DEXCOM G4 PLATINUM CGM.

OBJECTIVE: Limited information is available on chronic use of sodium glucose cotransporter 2 inhibitors in type 1 diabetes (T1D). We conducted a retrospective review of T1D patients on Dexcom G4Platinum continuous glucose monitors (DCGMs) >1 year (mean, 4.6 years) who were prescribed canagliflozin (CANA) 100 mg daily and had a baseline DCGM 30-day download prior to and a second download after at least 1 month (mean, 3.7 months) taking CANA 100 mg daily. The glycemic, weight, and systolic blood pressure (SBP) effects are reported. METHODS: We identified 27 patients meeting the selection criteria: 14 men; 25 white; 22 on pump; average T1D duration, 34 years (range, 12 to 48 years); average hemoglobin A1C (A1C), 7.6% (range, 6.1 to 9.8%); 22 with baseline A1C 7.0% or higher. All patients had an estimated glomerular filtration rate (eGFR) at baseline of 60 mL/min/1.73 m(2) or higher and were normotensive or on stable therapy. On average, 29 days of CGM data was reviewed. Total daily insulin dose (TDD) was available in 21 patients. We identified 27 patients who were judged to be candidates for CANA but did not have any change in glycemic therapy other than insulin adjustment as controls. RESULTS: CANA resulted in significant reductions in mean blood glucose, CGM standard deviation, time in hyperglycemia, A1C, weight, SBP, and TDD, with increased time in target, with minimal increase in hypoglycemia and no significant change in eGFR. Three females developed genital mycotic infections but continued therapy, 2 developed ketoacidosis from insulin interruption. CONCLUSION: CANA offers promise as adjunct therapy in T1D, though caution is advised.

Personal real-time continuous glucose monitoring in patients 65 years and older.

OBJECTIVE: Little information is available on personal real-time continuous glucose monitoring (PCGM) in patients ≥65 years old. We report on PCGM use in insulin-requiring patients ≥65 years old in a community endocrine practice. METHODS: Patients ≥65 or older who had been prescribed PCGM were identified by retrospective review. Glycated hemoglobin (A1C) values from the year prior and subsequent to PCGM prescription, the most recent A1C value, continued PCGM usage, percentage reporting severe hypoglycemia (SH), and rate of SH were examined. RESULTS: Thirty-eight patients were identified: 31 with type 1 diabetes, 21 females, mean age 70 years (range 65-78), and a mean diabetes duration of 31 years. Overall, 28 were on insulin pump therapy, 29 were using PCGM regularly, and 25 had both pre- and post-PCGM use A1C results. Regular PCGM use was associated with a decrease in mean (SD) A1C: 7.6 (0.9)% to 7.1 (0.9)%, (P<.0001) that was maintained until the most recent A1C value (7.2 [0.8]%, P = .0145, average 37 months), with fewer reporting SH (from 79% to 31%, P = .0002), and a lower rate of SH (0.37 to 0.12 per year, P = .0007). The group of 9 patients who did not continue PCGM (mean use 3 months) was too small to allow meaningful statistical evaluation. Lack of insurance coverage was the most common reason given for not using/continuing PCGM. Those continuing PCGM were more likely to have insurance coverage for PCGM (86%) than those not continuing PCGM (25%). CONCLUSIONS: Patients ≥65 with insulin-requiring diabetes achieve improved glycemic control with regular PCGM use. The presence of PCGM insurance coverage favored continued PCGM use.

Hemoglobin A1C, mean glucose, and persistence of glycation ratios in insulin-treated diabetes.

OBJECTIVE: Determine the relationship between mean glucose (MG), as assessed by continuous glucose monitoring (CGM), and hemoglobin A1c (A1C) in insulin-requiring adults in a clinical practice setting and examine the persistence of this relationship over time. METHODS: In this retrospective record review in a diabetes practice, a linear regression model was developed using data sets from all patients with ≥1 available download of a Dexcom SevenPlus CGM device in which there was >50% utilization in the 60 days prior to a laboratory A1C. Persistence of the MG to A1C relationship was examined in patients with ≥2 data sets available. RESULTS: A total of 139 patients had ≥1 data set available for evaluation, and 101 patients had ≥2 data sets (range, 2 to 6; total, 279). The slope of the MG versus A1C curve was 19.5 mg/dL for each 1% change in A1C, with an intercept of 17.7 mg/dL. Although 88% of the measured MG values were within 15% of the A1C-predicted MG, there was substantial variation in individuals, with differences as large as ±26%. The MG to A1C (MG:A1C) ratio, which is a measure of glycation, was normally distributed, with a median of 21.6. Spearman correlation coefficients for the MG:A1C ratio on repeated measures ranged from 0.52 to 0.73, demonstrating persistence. CONCLUSION: The relationship between MG and A1C is linear in a population but can vary between individuals. The MG:A1C ratio was normally distributed, tended to persist in individuals over time, and thus could be useful to identify apparent high and low glycators. Glycemic goals may need to be modified in such patients.