Type 1 DiabetesCGMHYPONCT05574023

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

A study testing Use of Predictive Alarm for hypoglycaemia or hyperglycaemia and Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia in people with Type 1 Diabetes, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Use of Predictive Alarm for hypoglycaemia or hyperglycaemia and Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteItaly
Study dates: 10 May 2021to 10 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

Pediatric Diabetes and Metabolic Disorders Unit, Surgery, Dentistry, Paediatrics and Gynaecology, University of Verona, 1 Piazzale Stefani
Verona, 37126

Other trials in Italy

About this study

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).

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.

Conditions: Type 1 Diabetes
Being tested: Use of Predictive Alarm for hypoglycaemia or hyperglycaemia, Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Use of Predictive Alarm for hypoglycaemia or hyperglycaemiaDevice
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.
1. in case of alarm from the hypoglycemia predictive algorithm, the indicated treatment was 0.1g of sugar/kg of body weight;
2. 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 hyperglycaemiaDevice
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.

Study groups in NCT05574023
Study group	Role	What they receive
Predictive Alarm (PA)	Experimental	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. Receives: Device: Use of Predictive Alarm for hypoglycaemia or hyperglycaemia
Alarm on Threshold (AoT)	Active comparator	Patients use the CGM sensor with alarms on a threshold of 70 mg/dl for hypoglycemia and 250 mg/dl for hyperglycemia. Receives: Device: Use of Alarm on Threshold for hypoglycaemia or hyperglycaemia

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 weeks CGM data with PA vs 2 weeks CGM data with AoT

Secondary outcomes (1)

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)
Measured: 2 weeks CGM data with PA vs 2 weeks CGM data with AoT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 202110 Jun 2022

First posted10 Oct 2022
Study start10 May 2021
Primary completion28 Mar 2022
Study completion10 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This is a crossover, monocentric and randomized study with a post-market medical device.
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05574023
Sponsor's protocol ID: 3142CESC
Acronym: CGMHYPO
Status last verified: Jul 2022
First submitted: 7 Oct 2022
Last updated: 10 Oct 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28585879
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.
PubMed 27356172
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.
PubMed 28700272
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.
PubMed 30063162
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. No abstract available.
PubMed 30039513
van Beers CA, DeVries JH, Kleijer SJ, Smits MM, Geelhoed-Duijvestijn PH, Kramer MH, Diamant M, Snoek FJ, Serne EH. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016 Nov;4(11):893-902. doi: 10.1016/S2213-8587(16)30193-0. Epub 2016 Sep 15.
PubMed 27641781
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. Epub 2019 Jan 25.
PubMed 30681379
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, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.
PubMed 29162583
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.
PubMed 28541136
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 2018 Aug 30.
PubMed 30160523
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 Technol. 2020 Mar;14(2):277-283. doi: 10.1177/1932296819838525. Epub 2019 Mar 31.
PubMed 30931606
Marigliano M, Piona C, Mancioppi V, Morotti E, Morandi A, Maffeis C. Glucose sensor with predictive alarm for hypoglycaemia: Improved glycaemic control in adolescents with type 1 diabetes. Diabetes Obes Metab. 2024 Apr;26(4):1314-1320. doi: 10.1111/dom.15432. Epub 2024 Jan 4.
PubMed 38177091

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT05574023
Acronym / sponsor ID: CGMHYPO / 3142CESC
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
Study start: 10 May 2021 (actual)
Primary completion: 28 Mar 2022 (actual)
Study completion: 10 Jun 2022 (actual)
First posted: 10 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: This is a crossover, monocentric and randomized study with a post-market medical device.

Arm	Type	Receives
Predictive Alarm (PA)	Experimental	Device: Use of Predictive Alarm for hypoglycaemia or hyperglycaemiaPatients 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.
Alarm on Threshold (AoT)	Active comparator	Device: Use of Alarm on Threshold for hypoglycaemia or hyperglycaemiaPatients use the CGM sensor with alarms on a threshold of 70 mg/dl for hypoglycemia and 250 mg/dl for hyperglycemia.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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);

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Use of Predictive Alarm for hypoglycaemia or hyperglycaemiaPatients 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. 1. in case of alarm from the hypoglycemia predictive algorithm, the indicated treatment was 0.1g of sugar/kg of body weight; 2. 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.	Device	Predictive Alarm (PA)
Use of Alarm on Threshold for hypoglycaemia or hyperglycaemiain 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.	Device	Alarm on Threshold (AoT)

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
Background: PubMed 28585879Rodbard 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.
Background: PubMed 27356172Taleb 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.
Background: PubMed 28700272Christiansen 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.
Background: PubMed 30063162Slover 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.
Background: PubMed 30039513Sherr 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. No abstract available.
Results publication: PubMed 27641781van Beers CA, DeVries JH, Kleijer SJ, Smits MM, Geelhoed-Duijvestijn PH, Kramer MH, Diamant M, Snoek FJ, Serne EH. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016 Nov;4(11):893-902. doi: 10.1016/S2213-8587(16)30193-0. Epub 2016 Sep 15.
Results publication: PubMed 30681379Welsh 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. Epub 2019 Jan 25.
Results publication: PubMed 29162583Danne 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, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.
Results publication: PubMed 28541136Wright 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.
Results publication: PubMed 30160523Stone 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 2018 Aug 30.
Results publication: PubMed 30931606Leelarathna 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 Technol. 2020 Mar;14(2):277-283. doi: 10.1177/1932296819838525. Epub 2019 Mar 31.
Derived from this study: PubMed 38177091Marigliano M, Piona C, Mancioppi V, Morotti E, Morandi A, Maffeis C. Glucose sensor with predictive alarm for hypoglycaemia: Improved glycaemic control in adolescents with type 1 diabetes. Diabetes Obes Metab. 2024 Apr;26(4):1314-1320. doi: 10.1111/dom.15432. Epub 2024 Jan 4.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05574023, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.