Using Glucose Sensors to Prevent Hypoglycemia

Type 1 Diabetes Clinical Trial

Official title:

Paradigm Real Time Continuous Glucose Monitoring Device for the Prevention of Hypoglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554281
• Other study ID #: UAHREB6344
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2007
• Last updated: September 12, 2011
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: September 2011
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Device:
• Use of glucose sensor (Paradigm Guardian)
Use glucose sensor to prevent episodes of severe hypoglycemia

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in HYPO score		3 months	No
Secondary	Number of episodes of severe hypoglycemia		3 months	Yes
Secondary	Number of patients who decide to continue using the device		3 months	No