OBJECTIVE: To assess the impact of continuous glucose monitoring on hypoglycemia in people with type 1 diabetes. RESEARCH DESIGN AND METHODS: In this randomized, controlled, multicenter study, 120 children and adults on intensive therapy for type 1 diabetes and a screening level of glycated hemoglobin A(1c) (HbA(1c)) (7.5% were randomly assigned to a control group performing conventional home monitoring with a blood glucose meter and wearinga masked continuous glucose monitor every second week for five days or to a group with real-time continuous glucose monitoring. The primary outcome was the time spent in hypoglycemia (interstitial glucose concentration (63 mg/dL) over a period of 26 weeks. Analysis was by intention to treat for all randomized patients. RESULTS: The time per day spent in hypoglycemia was significantly shorter in the continuous monitoring group than in the control group (mean +/- SD 0.48 +/- 0.57 and 0.97 +/- 1.55 h/day, respectively; ratio of means 0.49; 95% CI 0.26-0.76; P = 0.03). HbA(1c) at 26 weeks was lower in the continuous monitoring group than in the control group (difference -0.27%; 95% CI -0.47 to -0.07; P = 0.008). Time spent in 70 to 180 mg/dL normoglycemiawas significantly longer in the continuous glucose monitoring group compared with the control group (mean hours per day, 17.6 vs. 16.0, P = 0.009). CONCLUSIONS: Continuous glucose monitoring was associated with reducedtime spent in hypoglycemia and a concomitant decrease in HbA(1c) in children and adults with type 1 diabetes.
COBISS.SI-ID: 29623001
OBJECTIVE: To investigate whether lower risk HLA class II genotypes would influence the efficacy of DiaPep277 therapy in protecting beta-cell function evaluated by C-peptide secretion in recent-onset type 1 diabetic subjects. RESEARCH DESIGN AND METHODS: Data were collected from type 1 diabetic subjectsenrolled in multicenter phase II studies with a randomized, double-blind, and placebo-controlled design in whom fasting and stimulated C-peptide levels were measured. HLA genotypes were classified in high, moderate, and low risk categories. RESULTS: A total of 146 subjects (aged 4.3 to 58.5 years) were enrolled, including 76 children ((18 years old) and 70 adults. At baseline, there was a significant increase in fasting, maximal, andarea under the curve (AUC) C-peptide from high to moderate and low risk HLAgenotypes in adults (P for trend (0.04) but not in children. Children showed a decrease of the three parameters over time regardless of therapy and HLA genotype. DiaPep277-treated adults with low risk genotype had significantly higher maximal and AUC C-peptide versus placebo at 12 months (0.04 +/- 0.07 vs. -0.28 +/- 0.09 nmol/L, P ( 0.01, and 0.53 +/- 1.3 vs. -4.59+/- 1.5 nmol/L, P ( 0.05, respectively). In the moderate risk genotype group, Deltamaximal and AUC C-peptide values were significantly higher in DiaPep277-treated versus placebo-treated patients (P ( 0.01 and P ( 0.05, respectively). CONCLUSIONS: This exploratory study demonstrates that type 1 diabetic adults with low and moderate risk HLA genotypes benefit the most fromintervention with DiaPep277; the only subgroup with an increase of C-peptide at 12 months after diagnosis was the low risk DiaPep277-treated subgroup.
COBISS.SI-ID: 29623513
BACKGROUND: GH has an insulin antagonist effect, and GH treatment has therefore been suggested to impair glucose metabolism and increase risk of diabetes mellitus. SETTING: Data from 11,686 GH-treated patients in the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS), a multinational observational study of children with growth disorders, were analyzed for diabetes incidence. Baseline diabetes prevalence was determined from a GH-naive subgroup. METHODS: Prevalence and incidence (bystandardized incidence ratio) were compared with results from patients agedless than 20 yr in the U.S. SEARCH for Diabetes in Youth study. RESULTS: Baseline type 1 diabetes prevalence per 1000 persons was 4.92 (95% confidenceinterval = 1.91-12.58) in GeNeSIS and 1.03 (0.97-1.10) in SEARCH for0- to 9-yr-olds, and 7.33 (4.20-12.77) and 2.99 (2.78-2.98), respectively, for 10- to 19-yr-olds; there were no GeNeSIS cases of type 2 diabetes before GH initiation. During a median 1.8 yr of GH treatment, diabetes standardized incidence ratios for U.S. patients were 1.4 (0.5-3.1) for type 1 and 8.5 (2.8-19.5) for type 2, and for all patients was 1.4 (0.7-2.4) for type 1 and 6.5 (3.3-11.7) for type 2. Among the 11 patients with incident type 2 diabetes, risk factors for diabetes were identified in 10 patients. Glucose concentrations normalized for seven of nine patients for whom glycemic status could be determined (three of whom continued GH therapy and four who discontinued). CONCLUSION: The incidence of type 2 diabetes was higher in GH-treated children than the general population. Monitoring of glucose, beforeand periodically during GH treatment, is recommended for those with preexisting type 2 diabetes risk factors.
COBISS.SI-ID: 29622745