Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes
Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes
Looking for strict normoglycemia in type 1 diabetes increases the risk of hypoglycemia,
 exposing to hypoglycemia unawareness. It has been shown that the early correction of
 hypoglycemia can help recovering the perception of hypoglycemia. The purpose of this
 prospective study was to assess the value of sensor-augmented insulin-pump therapy to treat
 hypoglycemia unawareness.
To confirm hypoglycemia unawareness, patients answered a questionnaire based on the items
 explored by the model of Clarke 19 about hypoglycemia and hypoglycemia awareness. The
 eligibility of patients was confirmed by a blinded CG M recording using the trademark iPro ™
 2 sensor for 6 days. During this period the patient reported on a logbook the perception of
 their hypoglycemia, symptoms and how any hypoglycemia was corrected. Hypoglycemic
 manifestations were divided into adrenergic (shakiness, anxiety, palpitations, sweating,
 hunger, nausea, headache, coldness and pallor) and neuroglycopenic effects (impaired
 judgment, moodiness, paresthesia, emotional lability, confusion, ataxia, double vision,
 amnesia, seizures and lethargy). The confrontation of hypoglycemia detected by the blinded CG
 M and self-reported hypoglycemia validated the diagnosis of hypoglycemia unawareness.

 Patients used the Paradigm® Veo™ pump and glucose sensors (trademark : Enlite®) with an
 hypoglycemia alarm set at sensor glucose value of 70 mg/dL while the LG S option was set to
 suspend insulin delivery at a sensor glucose value of 50 mg/dL or less. These thresholds
 allowed an active correction of hypoglycemia by the patient between 50 and 70 mg/dL. Patients
 were educated to use the system and to treat and manage hypoglycemia. Pump data were uploaded
 using the trademark Medtronic CareLink™ Management Software for Diabetes during visits at 10
 days (D10), 2 months (M2) and 3 months (M3). Hypoglycemia awareness was assessed by an
 initial quiz that was repeated at M3 and 6 months (M6). A blinded CGM iPro ™ 2 was also
 realized at M3 to validate the modifications after sensor-augmented insulin-pump therapy.
Inclusion Criteria:

 -  >18 years

 -  type 1 diabetes

 -  had been treated with insulin pump for more than three months

 -  had hypoglycemia unawareness with a hypoglycemia perception threshold below 60 mg/dL
 and/or had had at least one severe hypoglycemia event in the previous year

 Exclusion Criteria:

 -  > 18 years

 -  any serious disease that could interfere with the study

 -  pregnancy,

 -  incompatibility with monitoring,

 -  irregular management of diabetes,

 -  hearing loss and low vision,

 -  preventing them from using the devices