Impact of Continuous Glucose Monitoring (CGM) With Predictive Alarm for Hypoglycemia (Guardian Connect System) on Glycemic Control and Hypoglycemia Management in a Group of Adolescents With Type 1 Diabetes Mellitus Treated With Multiple Daily Insulin Injections (MDI).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Less time spent in hypoglycaemia using Predictive Alarm vs Alarm on Threshold
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •T1DM for at least 12 months [assessed by positivity of at least one of the antibodies against islet cells (ICA), insulin (IAA), glutamate dehydroxylase (GADA), islet antigen 2 (IA2A), or Zinc Transporter 8 Antibodies (ZnT8)];
- •MDI therapy from at least 6 months with basal-bolus treatment (long acting insulin analog plus rapid acting insulin analogue);
- •HbA1c < 9.0%
- •normal weight (BMI <85th percentile for age and gender);
- •no other chronic diseases (thyroiditis, celiac disease, etc) or eating behavior disorders (DCA);
- •signed informed consent from parents or legal guardians and patients (<18 y).
Exclusion Criteria
- •T1DM for less than 12 months;
- •CSII therapy
- •Previous usage of CGM with predictive alarm for hypoglycemia or hyperglycemia
- •MDI therapy from less than 6 months
- •use of regular insulin instead of rapid acting insulin analogue;
- •other chronic diseases (thyroiditis, celiac disease, etc.) or eating behavior disorders (DCA).
Arms & Interventions
Predictive Alarm (PA)
Patients use the CGM sensor with Predictive Alarm on set at 70 mg/dl in 20 minutes for hypoglycemia and at 250 mg/dl in 20 minutes for hyperglycemia.
Intervention: Use of Predictive Alarm for hypoglycaemia or hyperglycaemia (Device)
Alarm on Threshold (AoT)
Patients use the CGM sensor with alarms on a threshold of 70 mg/dl for hypoglycemia and 250 mg/dl for hyperglycemia.
Intervention: Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia (Device)
Outcomes
Primary Outcomes
Less time spent in hypoglycaemia using Predictive Alarm vs Alarm on Threshold
Time Frame: 2 weeks CGM data with PA vs 2 weeks CGM data with AoT
the difference in the percentage of time spent below 70 mg/dl (TBR \< 70 mg/dl) between the Alarm on Threshold (AoT) and the Predictive Alarm (PA) arms after 2 weeks of treatment
Secondary Outcomes
- Better glycemic metrics using Predictive Alarm vs Alarm on Threshold(2 weeks CGM data with PA vs 2 weeks CGM data with AoT)