Continuous glucose monitoring for patients with diabetes: an evidence-based analysis.

OBJECTIVE: To determine the effectiveness and cost-effectiveness of continuous glucose monitoring combined with self-monitoring of blood glucose compared with self-monitoring of blood glucose alone in the management of diabetes.

CLINICAL NEED: CONDITION AND TARGET POPULATION Diabetes is a chronic metabolic disorder that interferes with the body's ability to produce or effectively use insulin. In 2005, an estimated 816,000 Ontarians had diabetes representing 8.8% of the province's population. Type 1 or juvenile onset diabetes is a life-long disorder that commonly manifests in children and adolescents. It represents about 10% of the total diabetes population and involves immune-mediated destruction of insulin producing cells in the pancreas. The loss of these cells necessitates insulin therapy. Type 2 or "adult-onset" diabetes represents about 90% of the total diabetes population and is marked by a resistance to insulin or insufficient insulin secretion. The risk of developing type 2 diabetes increases with age, obesity and lack of physical activity. Approximately 30% of patients with type 2 diabetes eventually require insulin therapy.

TECHNOLOGY: Continuous glucose monitors (CGM) measure glucose levels in the interstitial fluid surrounding skin cells. These measurements supplement conventional self monitoring of blood glucose (SMBG) by monitoring the glucose fluctuations continuously over a stipulated period of time, thereby identifying fluctuations that would not be identified with SMBG alone. To use a CGM, a sensor is inserted under the skin to measure glucose in the interstitial fluid. The sensor is wired to a transmitter. The device requires calibration using a capillary blood glucose measurement. Each sensor continuously measures glucose every 5-10 seconds averaging these values every 5 minutes and storing this data in the monitors memory. Depending on the device used, the algorithm in the device can measure glucose over a 3 or 6 day period using one sensor. After the 3 or 6 day period, a new sensor is required. The device is equipped with alarms which warn the patient of impending hypo-or hyperglycemia. Two types of CGM are available: Systems that is stored in a monitor and can be downloaded later.Real time systems that continuously provide the actual glucose concentration on a display.

RESEARCH QUESTIONS: What is the effectiveness and cost-effectiveness of CGM combined with SMBG compared with SMBG alone in the management of diabetes?

SEARCH STRATEGY: A literature search was performed on September 15, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2002 until September 15, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.

INCLUSION CRITERIA: English languageRandomized controlled trials (N>30 patients)Adults or pediatric patients with insulin dependent diabetes (type 1 or 2 or gestational)Studies comparing CGM plus SMBG versus SMBG alone

EXCLUSION CRITERIA: Case studiesStudies that did not compare CGM plus SMBG versus SMBG aloneStudies that did not report statistical analysis of outcomes or data was unextractable

OUTCOMES OF INTEREST: Change in glycosylated hemoglobin (HbA1c)Frequency or duration of hypo-or hyperglycemic episodes or euglycemiaAdverse effects

SUMMARY OF FINDINGS: Moderate quality evidence that CGM + SMBG: is not more effective than self monitoring of blood glucose (SMBG) alone in the reduction of HbA1c using insulin infusion pumps for Type 1 diabetes.is not more effective than SMBG alone in the reduction of hypoglycemic or severe hypoglycemic events using insulin infusion pumps for Type 1 diabetes.