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

Type 1 Diabetes Clinical Trial

— CGMHYPO  

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574023
• Other study ID #: 3142CESC
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: July 2022
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 10, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Device:
• Use of Predictive Alarm for hypoglycaemia or hyperglycaemia
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
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.

Locations

Country	Name	City	State
Italy	Pediatric Diabetes and Metabolic Disorders Unit, Surgery, Dentistry, Paediatrics and Gynaecology, University of Verona, 1 Piazzale Stefani	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther. 2017 Aug;19(8):446-456. doi: 10.1089/dia.2017.0087. Epub 2017 Jul 12. — View Citation

Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffe — View Citation

Leelarathna L, Thabit H, Wilinska ME, Bally L, Mader JK, Pieber TR, Benesch C, Arnolds S, Johnson T, Heinemann L, Hermanns N, Evans ML, Hovorka R. Evaluating Glucose Control With a Novel Composite Continuous Glucose Monitoring Index. J Diabetes Sci Techno — View Citation

Rodbard D. Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. Diabetes Technol Ther. 2017 Jun;19(S3):S25-S37. doi: 10.1089/dia.2017.0035. Review. — View Citation

Sherr JL, Tauschmann M, Battelino T, de Bock M, Forlenza G, Roman R, Hood KK, Maahs DM. ISPAD Clinical Practice Consensus Guidelines 2018: Diabetes technologies. Pediatr Diabetes. 2018 Oct;19 Suppl 27:302-325. doi: 10.1111/pedi.12731. — View Citation

Slover RH, Tryggestad JB, DiMeglio LA, Fox LA, Bode BW, Bailey TS, Brazg R, Christiansen MP, Sherr JL, Tsalikian E, Kaiserman KB, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2018 Sep;20(9):576-584. doi: 10.1089/dia.2018.0109. Epub 2018 Jul 31. — View Citation

Stone MP, Agrawal P, Chen X, Liu M, Shin J, Cordero TL, Kaufman FR. Retrospective Analysis of 3-Month Real-World Glucose Data After the MiniMed 670G System Commercial Launch. Diabetes Technol Ther. 2018 Oct;20(10):689-692. doi: 10.1089/dia.2018.0202. Epub — View Citation

Taleb N, Emami A, Suppere C, Messier V, Legault L, Chiasson JL, Rabasa-Lhoret R, Haidar A. Comparison of Two Continuous Glucose Monitoring Systems, Dexcom G4 Platinum and Medtronic Paradigm Veo Enlite System, at Rest and During Exercise. Diabetes Technol Ther. 2016 Sep;18(9):561-7. doi: 10.1089/dia.2015.0394. Epub 2016 Jun 29. — View Citation

van Beers CA, DeVries JH, Kleijer SJ, Smits MM, Geelhoed-Duijvestijn PH, Kramer MH, Diamant M, Snoek FJ, Serné EH. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-lab — View Citation

Welsh JB, Gao P, Derdzinski M, Puhr S, Johnson TK, Walker TC, Graham C. Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems. Diabetes Technol Ther. 2019 Mar;21(3):128-132. doi: 10.1089/dia.2018.0374. Epu — View Citation

Wright LA, Hirsch IB. Metrics Beyond Hemoglobin A1C in Diabetes Management: Time in Range, Hypoglycemia, and Other Parameters. Diabetes Technol Ther. 2017 May;19(S2):S16-S26. doi: 10.1089/dia.2017.0029. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Less time spent in hypoglycaemia using Predictive Alarm vs Alarm on Threshold	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	2 weeks CGM data with PA vs 2 weeks CGM data with AoT
Secondary	Better glycemic metrics using Predictive Alarm vs Alarm on Threshold	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)	2 weeks CGM data with PA vs 2 weeks CGM data with AoT