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NCT Number: NCT05530369

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time In Range (TIR, 70-180 mg/dL)

    Time frame: 12 months

    Change in time spent in range (70-180 mg/dL) from baseline to 12 months

  2. Time In Range (TIR, 70-180 mg/dL)

    Time frame: 24 months

    Change in time spent in range (70-180 mg/dL) from baseline to 24 months; Change of 10% in time spent in range (70-180 mg/dL) compared from baseline to 24 months

  3. Diabetic eye disease

    Time frame: 12 months

    Change in presence of microvascular complication 'Diabetic eye disease' (preproliferative retinopathy, proliferative retinopathy, maculopathy) from baseline to 12 months

  4. Diabetic eye disease

    Time frame: 24 months

    Change in presence of microvascular complication 'Diabetic eye disease' (preproliferative retinopathy, proliferative retinopathy, maculopathy) from baseline to 24 months

  5. Nephropathy

    Time frame: 12 months

    Change in presence of microvascular complication 'Nephropathy' (albuminuria

    ≥ 20µg/min or eGFR < 60 ml/min/1,73m^2) from baseline to 12 months

  6. Nephropathy

    Time frame: 24 months

    Change in presence of microvascular complication 'Nephropathy' (albuminuria

    ≥ 20µg/min or eGFR < 60 ml/min/1,73m^2) from baseline to 24 months

  7. Neuropathy

    Time frame: 12 months

    Change in presence of microvascular complication 'Neuropathy' (monofilament score < 12/12) from baseline to 12 months

  8. Neuropathy

    Time frame: 24 months

    Change in presence of microvascular complication 'Neuropathy' (monofilament score < 12/12) from baseline to 24 months

Secondary outcomes

  1. HbA1c (%)

    Time frame: 12 months

    Change in HbA1c from baseline to 12 months

  2. HbA1c (%)

    Time frame: 24 months

    Change in HbA1c from baseline to 24 months

  3. Mean glucose (mg/dl)

    Time frame: 12 months

    Change in mean glucose (mg/dl) from baseline to 12 months

  4. Mean glucose (mg/dl)

    Time frame: 24 months

    Change in mean glucose (mg/dl) from baseline to 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study 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

Acronym: TIRCO

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Sep 7, 2022
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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