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Using Glucose Sensors to Prevent Hypoglycemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Edmond A Ryan, University of Alberta
ClinicalTrials.gov Identifier:
NCT00554281
First received: November 2, 2007
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Type 1 Diabetes
Hypoglycemia
 Device: Use of glucose sensor (Paradigm Guardian)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paradigm Real Time Continuous Glucose Monitoring Device for the Prevention of Hypoglycemia

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Decrease in HYPO score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of episodes of severe hypoglycemia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Number of patients who decide to continue using the device [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554281

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

Publications:

Responsible Party: Edmond A Ryan, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00554281     History of Changes
Other Study ID Numbers: UAHREB6344
Study First Received: November 2, 2007
Last Updated: September 12, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Type 1 diabetes
Hypoglycemia
Glucose sensor

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

ClinicalTrials.gov processed this record on May 21, 2013