Diabetes technology & therapeutics
-
Diabetes Technol. Ther. · Jan 2003
Comment Case ReportsInadvertent sulfonylurea overdosage and hypoglycemia in an elderly woman: failure of serum hypoglycemia screening.
We report a case of an 82 year-old woman who had two episodes of documented hypoglycemia. Initial laboratory testing revealed hyperinsulinemia and a negative serum sulfonylurea screen. While these data suggested the presence of an insulinoma, further evaluation of the case revealed inadvertent ingestion of glimepiride, a sulfonylurea not included in the standard serum sulfonylurea screen.
-
Diabetes Technol. Ther. · Jan 2003
Unrecognized hypo- and hyperglycemia in well-controlled patients with type 2 diabetes mellitus: the results of continuous glucose monitoring.
The aim of this study was to determine the prevalence and extent of glycemic excursions (hypo- and hyperglycemic) in elderly patients with well-controlled type 2 diabetes using a Continuous Glucose Monitor System (CGMS) (Medtronic MiniMed). Elderly patients (>65 years old) with type 2 diabetes were recruited if their glycosylated hemoglobin (HbA1c) was <7.5% and if their oral hypoglycemic therapy included a sulfonylurea. Patients were asked to undergo two consecutive 72-h periods of continuous glucose monitoring at baseline and then again at 1 month (total 288 h). ⋯ The CGMS was generally well tolerated, but 52% of patients could not be studied for the full 12 days of monitoring. Thus hypoglycemia and excessive postprandial glycemic excursions are common in well-controlled patients with type 2 diabetes treated with a sulfonylurea with or without metformin. The CGMS is a useful research and clinical tool to assess glycemia in patients with type 2 diabetes but is not tolerated by all subjects.
-
Diabetes Technol. Ther. · Jan 2002
Clinical TrialWhen should determination of ketonemia be recommended?
Diabetic ketoacidosis is a serious complication of type diabetes. beta-Hydroxybutyrate (beta-OHB) accounts for about 75% of ketones, and blood concentration can be determined with a sensor. The aim of this study was to investigate the frequency and degree of ketonemia in daily life of children with diabetes and to make a base for recommendations for determination of ketonemia in clinical practice. During 3 months 45 patients with type 1 diabetes since 1-10 years old (mean 4.4 +/- 3.3 years old) at the pediatric clinic in Linköping, Sweden, performed 24-h profiles (eight determinations) in 2 weeks with blood glucose and beta-OHB. ⋯ Already a value > 0.4 mmol/L seems abnormal, and we recommend that patients retest glucose and ketones with beta-OHB > 0.4 mmol/L. Furthermore, we recommend that diabetic children and adolescents measure beta-OHB when symptoms like nausea or vomiting occur to differentiate ketoacidosis from gastroenteritis, and during infections, during periods with high blood glucose (> 15 mmol/L), and if they notice ketonuria. Monitoring beta-OHB should be routine for patients on pump therapy.
-
On May 26, 1976, the Food and Drug Administration (FDA) began implementing the Medical Device Amendments to the Federal Food Drug and Cosmetic Act. These amendments give FDA specific authority to regulate "medical devices." Additional authority was provided in the Safe Medical Devices Act of 1990. The pathways to get in vitro diagnostic products to market for commercial distribution include: premarket notification [or 510(k)] and premarket approval (PMA). ⋯ Most submissions for invasive glucose devices are 510(k) applications. Through this process the manufacturer demonstrates that its device is substantially equivalent to another device that is already legally marketed, referred to as the predicate device. To date, noninvasive and minimally invasive glucose testings have been approved through the PMA process and will be discussed in a separate article.
-
Diabetes Technol. Ther. · Jan 2002
Diabetes disease management program for an indigent population empowered by telemedicine technology.
Mercy Health Center in Laredo, Texas implemented a Telemedicine Diabetes Disease Management Program to determine the impact of a web-based patient interface technology as part of a diabetes disease management program. The program featured the use of the Health Hero iCare Desktop and the Health Buddy appliance. The Mercy Health Center outcomes study aimed to assess the effect of telemedicine technology on the health of indigent border residents with diabetes. ⋯ Without technology and daily remote monitoring, standard patient care is based on episodic encounters between patients and their care providers, which does not allow for prevention, education, or early intervention. This program bridged the gap between office visits for the patients. The early intervention ultimately reduced the cost of care.