Effect of CGM With Predictive Alarm on Hypoglycemia in Young Patients With T1D.
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The use of continuous glucose monitoring (CGM) is becoming the new standard in glycometabolic
      control in patients with Type 1 Diabetes Mellitus (T1DM) even in subjects in multiple daily
      insulin injections (MDI). Compared to self-monitoring of blood glucose (SMBG), the CGM
      systems allow continuous monitoring of the glycemic trends contributing to modify the
      therapeutic habits of adult and pediatric patients with T1DM and allowing to better managing
      of critical situations such as hypoglycemia. Recently, the accuracy and reliability
      performance of the latest generation of CGMs using predictive alarm for hypoglycaemia and
      hyperglycemia has been compared to other commercially available CGM systems, showing good
      levels of concordance.

      The use of this new technology, through the continuous monitoring of the pre-and
      post-prandial glucose levels and the evaluation of the glycemic trends, could influence the
      therapeutic habits of patients and could substantially contribute to modifying insulin
      therapy. Furthermore, the presence of the predictive alarm technology for hypoglycemia could
      lead to reduce the number of hypoglycemic episodes and to modify the way these hypoglycemic
      episodes are managed; moreover, the use of this technology could improve the time spent in
      the target glycemic range [Time in Range (TIR), 70-180 mg/dl] with possible improvement also
      in glycemic variability control.
    


Intervention name(s): Use of Predictive Alarm for hypoglycaemia or hyperglycaemia; Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia
Intervention type(s): Device; Device
Intervention description(s): Patients use CGM sensor with Predictive Alarm set at 70 mg/dl in 20 minutes for hypoglycemia and at 250 mg/dl in 20 minutes for hyperglycemia.
in case of alarm from the hypoglycemia predictive algorithm, the indicated treatment was 0.1g of sugar/kg of body weight;
in case of alarm from the hyperglycemia predictive algorithm, the indication was to give an extra shot of rapid-acting insulin. The dose will be calculated on the basis of personal insulin sensitivity factor (ISF), considering as target a blood glucose of 120 mg/dl and 250 mg/dl as the projected blood glucose level that will be reached in 20 minutes. This could be done only if there is no active insulin on-board, after at least 3 hours from the last rapid-acting insulin injection.; in case of alarm of hypoglycemia, the indicated treatment was 0.3g of sugar/kg of body weight, max 15g.
in case of alarm of hyperglycemia, the indication will be to give an extra shot of rapid-acting insulin. The dose will be calculated on the basis of personal insulin sensitivity factor (ISF), considering as target a blood glucose of 120 mg/dl and 250 mg/dl as blood glucose level to correct. This could be done only if there is no active insulin on-board, after at least 3 hours from the last rapid-acting insulin injection.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a crossover, monocentric and randomized study with a post-market medical device.
Masking: None (Open Label)
Primary purpose: Treatment