Diabetes technology & therapeutics
-
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.
-
The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. ⋯ The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.