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Clinical Trials/NCT05574023
NCT05574023
Completed
Not Applicable

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).

Azienda Ospedaliera Universitaria Integrata Verona1 site in 1 country20 target enrollmentMay 10, 2021
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Enrollment
20
Locations
1
Primary Endpoint
Less time spent in hypoglycaemia using Predictive Alarm vs Alarm on Threshold
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2021
End Date
June 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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).

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)

Study Sites (1)

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