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Idaho Falls, ID, United States

Davis A.K.,Benaroya Research Institute | DuBose S.N.,Jaeb Center for Health Research | Haller M.J.,University of Florida | Miller K.M.,Jaeb Center for Health Research | And 10 more authors.
Diabetes Care | Year: 2015

OBJECTIVE It is generally accepted that complete b-cell destruction eventually occurs in individuals with type 1 diabetes, which has implications for treatment approaches and insurance coverage. The frequency of residual insulin secretion in a large cohort of individuals at varying ages of diagnosis and type 1 diabetes duration is unknown. RESEARCH DESIGN AND METHODS The frequency of residual insulin secretion was determined by measurement of nonfasting serum C-peptide concentration in 919 individuals with type 1 diabetes according to prespecified groups based on age at diagnosis and duration of disease (from 3 to 81 years' duration). Stimulated C-peptide was measured in those with detectable nonfasting values and a group of those with undetectable values as control. RESULTS The overall frequency of detectable nonfasting C-peptide was 29%, decreasing with time fromdiagnosis regardless of age at diagnosis. In all duration groups, the frequency of C-peptide was higher with diagnosis age >18 years compared with £18 years. Nineteen percent of those with undetectable nonfasting C-peptide were C-peptide positive upon stimulation testing. CONCLUSIONS The American Diabetes Association's definition of type 1 diabetes as "usually leading to absolute insulin deficiency" results in clinicians often considering the presence of residual insulin secretion as unexpected in this population. However, our data suggest that residual secretion is present in almost one out of three individuals 3 ormore years fromtype 1 diabetes diagnosis. The frequency of residual C-peptide decreaseswith time from diagnosis regardless of age at diagnosis, yet at all durations of disease, diagnosis during adulthood is associated with greater frequency and higher values of C-peptide. © 2015 by the American Diabetes Association.

Halford J.,Rocky Mountain Diabetes and Osteoporosis Center
Diabetes Technology and Therapeutics | Year: 2010

Background: Preventing the complications of diabetes requires tight control and minimizing blood glucose fluctuation. Pursuing these goals increases the risk of severe hypoglycemia. The authors hoped to identify if using continuous glucose monitoring (CGM) decreased the incidence of severe hypoglycemia, resulted in less fear of hypoglycemia, and improved patient empowerment and what impact CCM had on quality of life (QOL) issues. Methods: Questionnaires were used to gather demographic data, to measure educational experiences with CGM, QOL issues concerning fear of hypoglycemia and severe hypoglycemia, confidence to make changes to insulin regimens before and after using CGM, and the incidence of severe hypoglycemia before and while using CGM, and to assess the impact of CGM on QOL. Results: The data and answers reported suggest significantly less fear of hypoglycemia and severe hypoglycemia and increased patient empowerment with CGM. Further shown is a reduced incidence of acute complications as evidenced by significantly decreased incidence of severe hypoglycemia. CGM appears to have a significant, positive impact on the stress associated with having and managing diabetes. Conclusions: Using CGM as part of the diabetes self-management plan offers the potential to significantly improve user outcomes as measured by QOL, reduction of fear, and patient empowerment. Using CGM can allow patients to achieve tighter control of their blood glucose values with reduced fear of hypoglycemia, reduced incidence of severe hypoglycemia, and a decreased sense of burden from having diabetes. Copyright 2010 Mary Ann Liebert, Inc.

Arakaki R.F.,University of Hawaii at Manoa | Blevins T.C.,Texas Diabetes and Endocrinology | Wise J.K.,Diabetes and Metabolism Associates | Liljenquist D.R.,Rocky Mountain Diabetes and Osteoporosis Center | And 4 more authors.
Diabetes, Obesity and Metabolism | Year: 2014

Aims: To compare efficacy and safety of two, once-daily basal insulin formulations [insulin lispro protamine suspension (ILPS) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (OAMs) and exenatide BID in suboptimally controlled type 2 diabetes (T2D) patients. Methods: This 24-week, open-label, multicentre trial randomized patients to bedtime ILPS (n=171) or glargine (n=168). Non-inferiority of ILPS versus glargine was assessed by comparing the upper limit of 95% confidence intervals (CIs) for change in haemoglobin A1c (HbA1c) from baseline to week 24 (adjusted for baseline HbA1c) with non-inferiority margin 0.4%. Results: Non-inferiority of ILPS versus glargine was demonstrated: least-squares mean between-treatment difference (ILPS minus glargine) (95% CI) was 0.22% (0.06, 0.38). Mean HbA1c reduction was less for ILPS- versus glargine-treated patients (-1.16±0.84 vs. -1.40±0.97%, p=0.008). Endpoint HbA1c<7.0% was achieved by 53.7% (ILPS) and 61.7% (glargine) (p=NS). Overall hypoglycaemia rates (p=NS) and severe hypoglycaemia incidence (p=NS) were similar. Nocturnal hypoglycaemia rate was higher in patients treated with ILPS versus glargine (p=0.004). Weight gain was similar between groups (ILPS: 0.27±3.38kg; glargine: 0.66±3.93kg, p=NS). Endpoint total insulin doses were lower in patients treated with ILPS versus glargine (0.30±0.17 vs. 0.37±0.17IU/kg/day, p<0.001). Conclusions: ILPS was non-inferior to glargine for HbA1c change over 24weeks, but was associated with less HbA1c reduction and more nocturnal hypoglycaemia. Treat-to-target basal insulin therapy improves glycaemic control and is associated with minimal weight gain when added to OAMs and exenatide BID for suboptimally controlled T2D. © 2013 The Authors. Diabetes, Obesity and Metabolism published by JohnWiley & Sons Ltd.

Weinstock R.S.,New York University | DuBose S.N.,Jaeb Center for Health Research | Bergenstal R.M.,Park Nicollet International Diabetes Center | Chaytor N.S.,University of Washington | And 21 more authors.
Diabetes Care | Year: 2016

OBJECTIVE Severe hypoglycemia is common in older adults with long-standing type 1 diabetes, but little is known about factors associated with its occurrence. RESEARCH DESIGN AND METHODS A case-control study was conducted at 18 diabetes centers in the T1D Exchange Clinic Network. Participantswere ≥60 years oldwith type 1 diabetes for ≥20 years. Case subjects (n = 101) had at least one severe hypoglycemic event in the prior 12months. Control subjects (n = 100), frequency-matched to case subjects by age, had no severe hypoglycemia in the prior 3 years. Data were analyzed for cognitive and functional abilities, social support, depression, hypoglycemia unawareness, various aspects of diabetes management, C-peptide level, glycated hemoglobin level, and blinded continuous glucose monitoring (CGM) metrics. RESULTS Glycated hemoglobin (mean 7.8% vs. 7.7%) and CGM-measured mean glucose (175 vs. 175 mg/dL) were similar between case and control subjects. More case than control subjects had hypoglycemia unawareness: only 11% of case subjects compared with 43% of control subjects reported always having symptoms associated with low blood glucose levels (P < 0.001). Case subjects had greater glucose variability than control subjects (P = 0.008) and experienced CGM glucose levels <60 mg/dL for ≥20 min on 46% of days compared with 33% of days in control subjects (P = 0.10). On certain cognitive tests, case subjects scored worse than control subjects. CONCLUSIONS In older adults with long-standing type 1 diabetes, greater hypoglycemia unawareness and glucose variability are associated with an increased risk of severe hypoglycemia. A study to assess interventions to prevent severe hypoglycemia in high-risk individuals is needed. © 2016 by the American Diabetes Association.

Christiansen M.,Diablo Clinical Research | Bailey T.,AMCR Institute Inc. | Liljenquist D.,Rocky Mountain Diabetes and Osteoporosis Center | Price D.,Dexcom | And 3 more authors.
Diabetes Technology and Therapeutics | Year: 2013

Background: Use of continuous glucose monitoring (CGM) systems can improve glycemic control, but widespread adoption of CGM utilization has been limited, in part because of real and perceived problems with accuracy and reliability. This study compared accuracy and performance metrics for a new-generation CGM system with those of a previous-generation device. Subjects and Methods: Subjects were enrolled in a 7-day, open-label, multicenter pivotal study. Sensor readings were compared with venous YSI measurements (blood glucose analyzer from YSI Inc., Yellow Springs, OH) every 15 min (±5 min) during in-clinic visits. The aggregate and individual sensor accuracy and reliability of a new CGM system, the Dexcom® (San Diego, CA) G4™ PLATINUM (DG4P), were compared with those of the previous CGM system, the Dexcom SEVEN® PLUS (DSP). Results: Both study design and subject characteristics were similar. The aggregate mean absolute relative difference (MARD) for DG4P was 13% compared with 16% for DSP (P<0.0001), and 82% of DG4P readings were within ±20 mg/dL (for YSI ≤80 mg/dL) or 20% of YSI values (for YSI >80 mg/dL) compared with 76% for DSP (P<0.001). Ninety percent of the DG4P sensors had an individual MARD ≤20% compared with only 76% of DSP sensors (P=0.015). Half of DG4P sensors had a MARD less than 12.5% compared with 14% for the DSP sensors (P=0.028). The mean absolute difference for biochemical hypoglycemia (YSI <70 mg/dL) for DG4P was 11 mg/dL compared with 16 mg/dL for DSP (P<0.001). Conclusions: The performance of DG4P was significantly improved compared with that of DSP, which may increase routine clinical use of CGM and improve patient outcomes. © 2013 Mary Ann Liebert, Inc.

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