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Diabetes Mellitus, Type 1TIRCONCT05530369

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

An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Antwerp.

Completed

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

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
How many people
479 participants
Where
No sites listed yet
Study dates
1 Sep 2014to 30 Aug 2022
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Pregnancy
  • Patients that had beta-cell transplantation

About this 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

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.

Read the 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.

Keywords
Type 1 Diabetes, HbA1c, Time In Range, Chronic complications, Continuous Glucose Monitoring
Medical subject headings
Diabetes Mellitus, Type 1

What is being measured

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

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

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

    Measured: 12 months

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

    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

    Measured: 24 months

  3. Diabetic eye disease

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

    Measured: 12 months

  4. Diabetic eye disease

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

    Measured: 24 months

  5. Nephropathy

    Change in presence of microvascular complication 'Nephropathy' (albuminuria

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

    Measured: 12 months

  6. Nephropathy

    Change in presence of microvascular complication 'Nephropathy' (albuminuria

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

    Measured: 24 months

  7. Neuropathy

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

    Measured: 12 months

  8. Neuropathy

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

    Measured: 24 months

Secondary outcomes (4)

  1. HbA1c (%)

    Change in HbA1c from baseline to 12 months

    Measured: 12 months

  2. HbA1c (%)

    Change in HbA1c from baseline to 24 months

    Measured: 24 months

  3. Mean glucose (mg/dl)

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

    Measured: 12 months

  4. Mean glucose (mg/dl)

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

    Measured: 24 months

Timeline

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

  1. First posted7 Sep 2022
  2. Study start1 Sep 2014
  3. Primary completion30 Nov 2021
  4. Study completion30 Aug 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
479 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05530369
Sponsor's protocol ID
TIRCO
Acronym
TIRCO
Status last verified
Aug 2022
First submitted
2 Sep 2022
Last updated
30 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by University Hospital, Antwerp.

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 3 inclusion and 2 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 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Time In Range (TIR, 70-180 mg/dL) (time frame: 12 months). The study lists 8 primary outcomes in all. 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 NCT05530369.

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 30 Sep 2022.

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