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Completed

NCT Number: NCT05574023

Effect of CGM With Predictive Alarm on Hypoglycemia in Young Patients With T1D.

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Diabetes and Metabolic Disorders Unit, Surgery, Dentistry, Paediatrics and Gynaecology, University of Verona, 1 Piazzale Stefani

Verona, 37126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Use of Predictive Alarm for hypoglycaemia or hyperglycaemia

Device

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.

Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia

Device

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.

Primary outcomes

  1. 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

  1. Better glycemic metrics 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 in 70-180 mg/dl range (TIR) between the Alarm on Threshold (AoT) and Predictive Alarm (PA) arms after 2 weeks of treatment (V2 vs V1 and V4 vs V3); the difference in the percentage of time spent above 250 mg/dl (TAR > 250 mg/dl) between the Alarm on Threshold and Predictive Alarm arms after 2 weeks of treatment (V2 vs V1 and V4 vs V3).

    the difference in main glucose metrics (%TIR, %TBR, %TAR) and glucose variability measures (SD, %CV, MAG, MAGE, HBGI, LBGI, ADRR, CONGA, MODD) between Group A (PA/AoT) and Group B (AoT/PA) at the end of the treatment period (V4) vs baseline (V1)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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).

Acronym: CGMHYPO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2022
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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