Clinical trial NCT05530369: The Link Between "Time In Range" Versus HbA1c and the Presence of Chronic COmplications in Type 1 Diabetes: a Longitudinal Study
Official title: The Link Between "Time In Range" Versus HbA1c and the Presence of Chronic COmplications in Type 1 Diabetes: a Longitudinal Study - The TIRCO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
HbA1c
Time In Range
Chronic complications
Continuous Glucose Monitoring
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 Standalone CGM and 13 patients who used Dexcom G4 and G6, resulting in a total of 479 patients.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus
* Using Real-Time Continuous Glucose Monitoring (rtCGM), Intermittently Scanned CGM (isCGM) or (Hybrid) Closed Loop (HCL) as diabetes treatment
* Willing to sign informed consent

Exclusion Criteria:

* Pregnancy
* Patients that had beta-cell transplantation

Primary outcomes:
measure: Time In Range (TIR, 70-180 mg/dL)
timeFrame: 12 months
measure: Time In Range (TIR, 70-180 mg/dL)
timeFrame: 24 months
measure: Diabetic eye disease
timeFrame: 12 months
measure: Diabetic eye disease
timeFrame: 24 months
measure: Nephropathy
timeFrame: 12 months
measure: Nephropathy
timeFrame: 24 months
measure: Neuropathy
timeFrame: 12 months
measure: Neuropathy
timeFrame: 24 months
Secondary outcomes:
measure: HbA1c (%)
timeFrame: 12 months
measure: HbA1c (%)
timeFrame: 24 months
measure: Mean glucose (mg/dl)
timeFrame: 12 months
measure: Mean glucose (mg/dl)
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Antwerp
name: Christophe De Block, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: