Using Glucose Sensors to Prevent Hypoglycemia
Using Glucose Sensors to Prevent Hypoglycemia
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.
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.
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