The Link Between "Time In Range" Versus HbA1c & the Presence of Chronic

Status Completed

Clinical Trial Summary

HbA1c is currently the only metric of glucose control showing an association with chronic complications of type 1 diabetes mellitus (T1D). Time in range (TIR, 70-180 mg/dL) measured by real-time continuous glucose monitoring (CGM) might be a better marker. In this study, the investigators studied the clinical significance of a 10% increase of TIR over two years.

Clinical Trial Description

Adult subjects (age ≥ 18 years) with T1D were consecutively recruited in three multicenter studies (RESCUE, FUTURE, ALERTT1 studies) organized between September 2014 and 19 November 2021. For the TIRCO study, only the data from patients recruited at the University Hospital of Antwerp were analyzed. Initially, the data from 498 patients were collected. Pregnant patients and patients with beta-cell transplantation were excluded from the study, resulting in the inclusion of 479 patients. Consecutive patients starting CGM were proposed to participate and were included into the study after signing informed consent. The study population consisted of 445 patients who used Freestyle libre, 21 patients who used CGM in hybrid closed loop and 13 patients who used Dexcom G4 and G6, resulting in a total of 479 patients. In this project, the investigators looked into the link between TIR versus HbA1c and the presence of chronic complications in adults with T1D. The primary endpoint was to evaluate the link between TIR and the presence of chronic microvascular complications as formulated by the following research question: "What is the clinical significance of a 10% increase of TIR over two years?" The secondary endpoint was to assess the link between TIR and independent risk factors for micro- and macrovascular complications such as sex, age, BMI, lipids, blood pressure, HbA1c, time in range, mean glucose, diabetes duration, method of insulin administration (MDI or CSII), type of sensor and sensor compliance. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05530369
Study type	Observational
Source	University Hospital, Antwerp
Contact
Status	Completed
Phase
Start date	September 1, 2014
Completion date	August 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Link Between "Time In Range" Versus HbA1c and the Presence of Chronic COmplications in Type 1 Diabetes: a Longitudinal Study — TIRCO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms