Using Glucose Sensors to Prevent Hypoglycemia
Paradigm Real Time Continuous Glucose Monitoring Device for the Prevention of Hypoglycemia
1 other identifier
interventional
16
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 2, 2007
CompletedFirst Posted
Study publicly available on registry
November 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedSeptember 13, 2011
September 1, 2011
1.8 years
November 2, 2007
September 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease in HYPO score
3 months
Secondary Outcomes (2)
Number of episodes of severe hypoglycemia
3 months
Number of patients who decide to continue using the device
3 months
Study Arms (2)
A
NO INTERVENTIONRun in period
B
EXPERIMENTALInterventions
Use glucose sensor to prevent episodes of severe hypoglycemia
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes Mellitus confirmed by C-peptide \<0.10 nmol/L
- age 18 - 70 yrs.
- HYPO score \>423
- normal TSH, serum cortisol and anti-transglutaminase (ATTG)
You may not qualify if:
- current diagnosis of cancer
- planning a pregnancy
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
University of Alberta
Edmonton, Alberta, T6G 2S2, Canada
Related Publications (1)
Ryan EA, Germsheid J. Use of continuous glucose monitoring system in the management of severe hypoglycemia. Diabetes Technol Ther. 2009 Oct;11(10):635-9. doi: 10.1089/dia.2009.0042.
PMID: 19821755RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edmond A Ryan, MD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 2, 2007
First Posted
November 6, 2007
Study Start
October 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
September 13, 2011
Record last verified: 2011-09