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Using Glucose Sensors to Prevent Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554281
Recruitment Status : Completed
First Posted : November 6, 2007
Last Update Posted : September 13, 2011
Information provided by (Responsible Party):
Edmond A Ryan, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Hypoglycemia Device: Use of glucose sensor (Paradigm Guardian) Phase 3

Detailed Description:

Sixteen patients with Type 1 diabetes (as defined by: onset under the age of 25, lean at time of onset, continuous insulin use, and/or history of ketoacidosis and C-peptide negative), with a HYPO score over the seventy-fifth percentile (>423), will be approached and offered the study.

The study will be conducted over a three month time-frame. The first month will be a run-in period for participants to collect four weeks of glucose readings and information about their hypoglycemic events. These records will be used to calculate the baseline modified HYPO score. Patients will be screened during the first month for thyroid disease, celiac disease and Addison's disease.

During the second month they will meet with the study nurse for an intensive instruction period on the use of the Paradigm RT sensor. They will spend this month practicing to use the sensor and confirming they can use it adequately.

During the final month they will wear the sensor and collect glucose and hypoglycemia records for calculation of the final modified HYPO score.

The end point will be the change from the baseline modified HYPO score to the final four week HYPO score and this would be used to identify any improvement.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paradigm Real Time Continuous Glucose Monitoring Device for the Prevention of Hypoglycemia
Study Start Date : October 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Dextrose

Arm Intervention/treatment
No Intervention: A
Run in period
Experimental: B Device: Use of glucose sensor (Paradigm Guardian)
Use glucose sensor to prevent episodes of severe hypoglycemia
Other Name: Paradigm Guardian glucose sensor

Primary Outcome Measures :
  1. Decrease in HYPO score [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Number of episodes of severe hypoglycemia [ Time Frame: 3 months ]
  2. Number of patients who decide to continue using the device [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • current diagnosis of cancer
  • planning a pregnancy
  • Inability to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00554281

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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
University of Alberta
Edmonton, Alberta, Canada, T6G 2S2
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Edmond A Ryan, MD University of Alberta

Publications of Results:
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Responsible Party: Edmond A Ryan, Professor, University of Alberta Identifier: NCT00554281     History of Changes
Other Study ID Numbers: UAHREB6344
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Edmond A Ryan, University of Alberta:
Type 1 diabetes
Glucose sensor

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases