Trial · Interventional

CompletedNot applicableRegistry data

Dual-hormone Artificial Pancreas Versus Single-hormone Under Exercise and a Meal Challenge

Short name TAILOR/3

NCTNCT06082973Other idTAILOR/3

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 15 participants (actual)
Sponsor: Universitat Politècnica de València · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Spain
Start: 15 May 2024
Primary completion: 30 May 2025
Completion: 30 May 2025
First posted: 13 Oct 2023
Last update posted: 18 Dec 2025
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

N/A
TAILOR/3
NCT06082973
15 May 2024 to 30 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The present clinical trial aims to examine alternative strategies for preventing/mitigating hypoglycemic events among adults with type 1 diabetes utilizing a highly personalized control system. This system offers two configurable options: a single-hormone configuration with automatic rescue carbohydrate recommendations (sHC) and a dual-hormone configuration with subcutaneously administered glucagon boluses (dHmG). The main question addressed in this study focuses on determining whether the dHmG outperforms the sHC in terms of minimizing the time spent below the target range and number of hypoglycemic events. Each participant will undergo two 12-hour controlled inpatient studies, including each an unannounced 30-min aerobic exercise session and a meal challenge. The order of these studies, comparing the dHmG to the sHC, will be randomized.

Interventions

Automated insulin delivery system algorithm with a dual-hormone configuration (insulin and glucagon) for glucose controlDevice
Automated insulin delivery system with a single-hormone configuration (insulin) with rescue carbohydrate recommendations for glucose controlDevice

Arms2

Experimental
Dual-hormone configuration system (insulin and glucagon)
12-hour inpatient study that will include an unannounced 30-min aerobic exercise session and a meal challenge. Automated insulin and glucagon delivery will be performed using a dual-hormone configuration system for glucose control .
Active comparator
Single-hormone configuration (insulin) with carbohydrate recommendations system
12-hour inpatient study that will include an unannounced 30-min aerobic exercise session and a meal challenge. Automated insulin delivery will be performed using a single-hormone configuration system with carbohydrate recommendations if needed for glucose control .

Primary outcomes2

Outcomes the sponsor listed as primary.

% time below range (<70 mg/dL)
Time frame · 12-hour inpatient study
Registry description
Percentage of time spent below the target range
Number of Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycemic events
Time frame · 12-hour inpatient study
Registry description
Occurrence of hypoglycemic events during at least 15 min

Secondary outcomes(13)

%time in range (70-180 mg/dL)
Time frame · 12-hour inpatient study
Registry description
Percentage of time spent within target range (70-180 mg/dL)
%time in range (70-140 mg/dL)
Time frame · 12-hour inpatient study
Registry description
Percentage of time spent within target range (70-140 mg/dL)
Time with glucose levels <3.0 mmol/l (54 mg/dl)
Time frame · 12-hour inpatient study
Registry description
Percentage of time spent with glucose levels \< 3.0 mmol/l (54 mg/dl)
Coefficient of variation (CV) of CGM values
Time frame · 12-hour inpatient study
Registry description
Glycemic variability
%time >180 mg/dL
Time frame · 12-hour inpatient study
Registry description
Percentage of time spent above 180 mg/dL
%time > 250 mg/dL
Time frame · 12-hour inpatient study
Registry description
Percentage of time spent above 250 mg/dL
Average glucose
Time frame · 12-hour inpatient study
Registry description
Average of sensor glucose levels (mg/dL)
Standard deviation
Time frame · 12-hour inpatient study
Registry description
Standard deviation of sensor glucose levels
Total insulin
Time frame · 12-hour inpatient study
Registry description
Total insulin administered during the inpatient study
Total glucagon
Time frame · 12-hour inpatient study
Registry description
Total glucagon administered during the inpatient study
Number of automatic rescue carbohydrate recommendations
Time frame · 12-hour inpatient study
Registry description
Number of rescue carbohydrate recommendations applied during the inpatient study
Number of glucagon boluses
Time frame · 12-hour inpatient study
Registry description
Number of glucagon boluses administered during the inpatient study
Total number of carbohydrates ingested
Time frame · 12-hour inpatient study
Registry description
Total number of carbohydrates ingested (g) during the inpatient study

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

8 results

Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study.

Laugesen et al. 2022Diabetes carecited by 9

PMID 35475907DOI 10.2337/dc21-2304PUB-35475907

Rights unknown8 results

Source link See results (8)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age between 18 and 65 years. * CSII treatment for a minimum of 6 months prior to Visit 1. * Body mass index between 18 and 30 kg/m2. * HbA1c level below 9.0% at Visit 1. * Physical examination, laboratory data, and ECG (electrocardiogram) results are within normal limits. Clinically insignificant abnormalities, as determined by the investigator, will not be considered exclusion criteria. * Postmenopausal women or women of childbearing age who have a negative urine pregnancy test during the screening visit. Exclusion Criteria: * Pregnancy or breastfeeding. * Hypoglycemia unawareness (as indicated by a Clarke Test score greater than 3). * Presence of progressive, fatal disease. * History of drug or alcohol abuse. * History of being HIV positive, active hepatitis B or hepatitis C. * Impaired liver function, as evidenced by serum glutamic-pyruvic transaminase (SGPT) or serum glutamic-oxaloacetic transaminase (SGOT) levels exceeding twice the upper limit of the reference normal range at Visit 1. * Clinically significant microvascular complications (such as macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine, or other systemic conditions, apart from T1D, that may hinder the implementation of the clinical study protocol or the interpretation of study results. * Scheduled surgery during the study period. * Mental conditions that affect the subject's ability to comprehend the nature, purpose, and potential consequences of the study. * Subjects deemed unlikely to adhere to the clinical study protocol, including those with an uncooperative attitude, inability to attend follow-up visits or low likelihood of completing the study. * Use of an experimental drug or device within the past 30 days.

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