Accuracy of an Electrochemical Sensor for Measuring Capillary Blood Ketones by Fingerstick Samples During Metabolic Deterioration After Continuous Subcutaneous Insulin Infusion Interruption in Type 1 Diabetic Patients

Abstract

OBJECTIVE -This study was designed to test the accuracy of capillary ketonemia for diagnosis of ketosis after interruption of insulin infusion. RESEARCH DESIGN AND METHODS-A total of 18 patients with type 1 diabetes treated by external pump were studied during pump stop for 5 h. Plasma and capillary ketonemia and ketonuria were determined every hour from 7:00 A.M. (time 0 min ϭ T0) to 12:00 P.M. (time 300 min ϭ T300). Plasma ␤-hydroxybutyrate (␤-OHB) levels were measured by an enzymatic end point spectrophotometric method, and capillary ␤-OHB levels were measured by an electrochemical method (MediSense Optium meter). Ketonuria was measured by a semiquantitative test (Ketodiastix). Positive ketosis was defined by a value of Ն0.5 mmol/l for ketonemia and Ն4 mmol/l (moderate) for ketonuria. RESULTS-After stopping the pump, concentrations of ␤-OHB in both plasma and capillary blood increased significantly at time 60 min (T60) compared with T0 (P Ͻ 0.001), reaching maximum levels at T300 (1.30 Ϯ 0.49 and 1.23 Ϯ 0.78 mmol/l, respectively). Plasma and capillary ␤-OHB values were highly correlated (r ϭ 0.94, P Ͻ 0.0001). For diagnosis of ketosis, capillary ketonemia has a higher sensitivity and negative predictive value (80.4 and 82.5%, respectively) than ketonuria (63 and 71.8%, respectively). For plasma glucose levels Ն250 mg/dl, plasma and capillary ketonemia were found to be more frequently positive (85 and 78%, respectively) than ketonuria (59%) (P ϭ 0.017). The time delay to diagnosis of ketosis was significantly higher for ketonuria than for plasma ketonemia (212 Ϯ 67 vs. 140 Ϯ 54 min, P ϭ 0.0023), whereas no difference was noted between plasma and capillary ketonemia.CONCLUSIONS -The frequency of screening for ketosis and the efficiency of detection of ketosis definitely may be improved by the use of capillary blood ketone determination in clinical practice. Diabetes Care 26:1137-1141, 2003T he Diabetes Control and Complications Trial (DCCT) has demonstrated that intensive diabetes management, multiple daily injections (MDI) in two-thirds of cases, and continuous subcutaneous insulin infusion (CSII) in one-third of cases could reduce the risk of development and progression of long-term complications of type 1 diabetes (1). CSII provides the most physiological pattern of insulin delivery currently available (2). However, it is now clearly established that CSII is associated with a substantial increase in risk of diabetic ketoacidosis (DKA) compared with MDI (3,4). In a meta-analysis of 14 studies, odds ratios (95% CI) were 7.20 (2.95-17.58) for exclusive use of insulin pumps compared with 1.13 (0.15-8.35) for MDI (4). Technical problems with CSII (pump failure, catheter occlusion, skin infection) may reduce insulin delivery or insulin absorption and cause DKA (5). Currently, the use of short-acting insulin analogs in external pumps is becoming more widespread because some studies have shown that the use of such analogs provides better glycemic control and stability than regular insulin (6 -8). Considering the pha...

Outpatient Safety Assessment of an In-Home Predictive Low-Glucose Suspend System with Type 1 Diabetes Subjects at Elevated Risk of Nocturnal Hypoglycemia

“…Our finding of infrequent ketonemia following pump suspension is consistent with prior studies that have shown that pump insulin delivery can be suspended for up to 5 h without producing significant ketonemia. [7][8][9] In studies of sensor-augmented pumps with a low glucose suspend feature (Paradigm VeoÔ; Medtronic Diabetes), no significant ketosis or ketoacidosis has been reported in thousands of 2-h nocturnal pump suspensions. [10][11][12][13] On intervention nights (algorithm operational), glucose levels tended to be lower on nights with pump suspension compared with nights without pump suspension, reflecting that there were lower glucose levels on nights triggering a suspension.…”

Effect of Gestational Diabetes on Circulating Levels of Maternal and Neonatal Carnitine

“…The assay range is 0.0-6.0 mmol/L. A previous study reported that the intra-assay coefficients of variation tested on three different levels of β-hydroxybutyrate (low at the mean of 0.43, moderate at 1.08, and high at 3.55 mmol/L) were 10.5, 5.5, and 3.2%, respectively [12].…”

Cetoacidose diabética em adultos: atualização de uma complicação antiga

“…Estudos mais recentes têm sugerido que a dosagem capilar de BHB possa também ser extremamente útil para o diagnóstico domiciliar de CAD incipiente, facilitando a recuperação precoce. É recomendada a medida domiciliar de cetonemia no sangue capilar ou cetonúria com fita reagente própria para pacientes com DM1 com hiperglicemia persistente acentuada (≥ 300 mg/dL ou até menos, a critério clíni-co), especialmente na vigência de stress ou quadros infecciosos (40)(41)(42)(43)(44).…”