Using Glucose Sensors to Prevent Hypoglycemia

NCT00554281 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-09-13

No results posted yet for this study

Summary

Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who strive for good glycemic control. In some patients there is a loss of awareness of hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such a situation may carry risks that the patient may harm him or her self. Medtronic has recently developed a continuous glucose sensor that determines the glucose level every 3 minutes using a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may be worn or left close by eg on a bedside table. The device may be programmed to alarm for a rapidly falling glucose or for low glucose levels.

We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO score and see if we can decrease the number of hypoglycemic reactions and document this improvement with a better HYPO score.

Conditions

Interventions

DEVICE

Use of glucose sensor (Paradigm Guardian)

Use glucose sensor to prevent episodes of severe hypoglycemia

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Edmond A Ryan, MD · University of Alberta

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554281 on ClinicalTrials.gov