Time in Range

An important metric that goes beyond HbA1c

Time in Range is a metric that complements HbA1c and provides actionable information for you and your patients. It helps you quickly assess patients’ glucose, contextualise their HbA1c and increase their Time in Range.

Understanding Time in Range (TIR)

What is Time in Range?   

Time in Range is a novel clinical measure that indicates the percentage of time individuals with diabetes spend within their target glycaemic range. This metric is determined using continuous glucose monitoring (CGM). It can be used alongside other CGM metrics like Time Below Range (TBR) for hypoglycaemia, Time Above Range (TAR) for hyperglycaemia, mean glucose and glycaemic variability to assess glycaemic control.1–3,5

According to the International Consensus Report on TIR1, most adults non pregnant with type 1 diabetes (T1D) or type 2 diabetes (T2D) should aim to spend at least 70 % of the day (approximately 17 hours) within the target range of 3.9-10 mmol/L , corresponding to the recommended HbA1c target of approximately 7 %.1

Following food choices, TIR is considered the next most important factor that affects the daily life of people with diabetes.4

What is the unmet need?   

The HbA1c reflects average blood glucose over the last 2–3 months. The limitation of HbA1c-testing is the lack of information about glycaemic excursions throughout the day and variability across days. Also, conditions, such as anemia, iron deficiency, or hemoglobinopathies can confound HbA1c measurements. CGM technology provides the ability for people with diabetes to immediately obtain information about their glucose levels and adjust their therapy per their HCPs advice.1

Recommended percentages of Time in Range, and Times below and above target glucose range have been established and can be personalised to address the individual needs of patients. This can facilitate safe and effective therapeutic decision making within the parameters of the established glycaemic goals.1

Time in Range & HbA1c 

TIR acts as a complement to glycated haemoglobin (HbA1c)1 – the established gold standard for evaluating glucose control.

TIR, akin to HbA1c, is associated with diabetes-related microvascular and macrovascular complications.6-10 However, HbA1c, which reflects average blood glucose levels over the past two to three months, fails to capture daily fluctuations and the variable occurrence of hypoglycaemia and hyperglycaemia.1

Actually, patients with the same HbA1c (7.6-7.7 %) may have very different glucose variability.11

For illustrative purposes only. Not actual patient data.

 

Time in Range provides more actionable information than HbA1c alone   

CGM-derived data include quantitative measures such as Time in Range, Time above Range, and Time below Range. When combined with HbA1c, they help healthcare professionals to quickly assess a patient’s glucose control and make more informed treatment decisions to enhance diabetes management. It enables people with diabetes to gain a comprehensive understanding of their glucose levels and provides insights into patterns of hypoglycaemia and hyperglycaemia throughout the day and night.1

Clinical benefits

Goals of effective and safe glucose control   

The primary goal for effective and safe glucose controls is to increase Time in Range while reducing Time below Range¹   

The international consensus sets clear targets for Time in Ranges.1

§ includes percentage of values >13.9 mmol/L

§§ includes percentage of values <3 mmol/L

  • The recommended glycaemic range for most people with diabetes (non-pregnant adults) is 3.0-10 mmol/L.
The 70 % target is chosen as it strongly correlates with an HbA1c goal of 7.0 %.1
  • Most people with T1D and T2D# should spend at least 70 % (approximately 17 hours) of the day within this glycaemic range.1
  • Most people with diabetes# are advised to spend less than 4 % of their day below range. TBR is the percentage of time spent below <3.9 mmol/L .1 Less than 1% of the time should be spent in the “very low” TBR of <3 mmol/L .1
  • Most people with diabetes# are advised to spend less than 25 % of their day above range. TAR is the percentage of time spent above > 10 mmol/l .1 Less than 5 % of the time should be spent in the “very high” TAR of >13.9 mmol/L.1

# For older and/or high-risk people with diabetes, the TIR target is lowered to >50% and TBR reduced to <1% at <3.9 mmol/L 1

The recommendations of International Consensus Report were endorsed by the following organisations: American Diabetes Association, American Association of Clinical Endocrinologists, American Association of Diabetes Educators, European Association for the Study of Diabetes, Foundation of European Nurses in Diabetes, International Society for Pediatric and Adolescent Diabetes, JDRF and Pediatric Endocrine Society.

Increased risk of microvascular and macrovascular complications is associated with decreased Time In Range6,9,10   

Studies have shown that TIR correlates with diabetes-related microvascular complications, such as diabetic retinopathy, microalbuminuria and neuropathy.6,9,10 

In T1D, for every 10 % decrease in TIR, the progression of retinopathy has been shown to increase by 64 % and the occurrence of microalbuminuria by 40 %.12 Also, a growing body of evidence suggests that lower TIR is associated with an increased risk of macrovascular complications, such as cardiovascular disease7,8 and all-cause mortality in people with type 2 diabetes.8

The relationship between increased TIR and decreased HbA1c13  

Each incremental 5 % increase in TIR is associated with clinically significant benefits for people with T1D or T2D.13,14  Every 10 % increase in TIR leads to a decrease in HbA1c of ~ 0.8 %.13

FreeStyle Libre technology & Time in Range

The FreeStyle Libre technology helps increase percentage of TIR   

Clinical data for the FreeStyle Libre 2 system in Type 1 Diabetes population.  

The FLASH-UK trial demonstrated the significant clinical benefits of the FreeStyle Libre 2 system (FSL 2) vs SMBG for people with T1D.16 The study by Leelarathna et al. (2022) was conducted as a parallel-group, multicentre, open-label, randomised controlled trial to determine the efficacy of the FreeStyle Libre 2 system vs. SMBG in improving glycaemic control in adults with T1D and suboptimal glucose control. Adults (≥16 years) n=156 with T1D MDI or CSII and HbA1c levels between 7.5 % and 11.0 % were enrolled.

*Glucose 3.9–10.0 mmol/L ; **Adjusted mean difference vs. SMBG (95% CI, 4.7-13.3).

CSII = Continuous subcutaneous insulin infusion; MDI = Multiple daily injections of insulin; SMBG = Self-monitoring of blood glucose; T1D = Type 1 diabetes.

Clinical data for the FreeStyle Libre system15 in Type 2 Diabetes population.  

This study by Lameijer et al. (2023) was conducted with the objective to evaluate the impact of initiating the FreeStyle Libre system on glycaemic parameters in patients with Type 2 Diabetes.17 The design involved a retrospective analysis of de-identified data from a database of European FreeStyle Libre system users between 2014 and 2021, comprising 1,813 adults (≥18 years) with T2D on MDI (n=1,499), basal insulin (n=189), or no insulin (n=125).
After 24 weeks, significant improvements were observed across all treatment modalities, with Time in Range increasing by +2.2 to +4.7 hours per day (p≤0.003).

* Glucose 3.9–10.0 mmol/L .

MDI = Multiple daily injections of insulin; TIR = Time in Range; T2D = Type 2 diabetes.

This real-world study indicates that individuals with Type 2 diabetes and suboptimal glycemic control experience significant improvements in glycemic outcomes when using FreeStyle Libre systems—regardless of whether they are treated with intensive insulin therapy, basal insulin alone, or oral antidiabetic medications.

References

For illustrative purposes only. Not actual patient data.

The FreeStyle Libre 2 Plus sensor and FreeStyle Libre 3 Plus sensor is intended for people aged 2 years and older.

1. Battelino, T. Diabetes Care (2019): https://doi.org/10.2337/dci19-0028.

2. Standards of Care in Diabetes. Diabetes Care (2024) 47 (Supplement_1): S111–S125 https://doi.org/10.2337/dc24-S006.

3. Danne, T. Diabetes Care (2017): https://doi.org/10.2337/dc17-1600. 

4. Runge, AS. Clin Diabetes (2018): https://doi.org/10.2337/cd17-0094.

5. Chehregosha, H. Diabetes Ther (2019): https://doi.org/10.1007/s13300-019-0619-1.

6. Ranjan, AG. Diabetes Care (2020): https://doi.org/10.2337/dc20-0909.

7. Lu, J. Diabetes Technol Ther (2020): https://doi.org/10.1089/dia.2019.0251.

8. Lu, J. Diabetes Care (2021): https://doi.org/10.2337/dc20-1862.

9. Mayeda, L. BMJ Open Diabetes Res Care (2020): https://doi.org/10.1136/bmjdrc-2019-000991.

10.Lu, J. Diabetes Care (2018): https://doi.org/10.2337/dc18-1131.

11. Dunn, TC. J Diabetes Sci Technol (2014): https://doi.org/10.1177/1932296814532200.

12. Beck, RW. Diabetes Care (2019): https://doi.org/10.2337/dc18-1444.

13. Vigersky, RA. Diabetes Technol Ther (2019): https://doi.org/10.1089/dia.2018.0310.

14. Beck, RW. J Diabetes Sci Technol (2019): https://doi.org/10.1177/1932296818822496.

15. Sale of the original FreeStyle Libre system has been discontinued in Norway, Sweden, Finalnd and Denmark. The FreeStyle Libre 2 and 3 systems are for sale, providing the same benefits as the original FreeStyle Libre system, with the added functionalities of optional Real-Time Alarms.

16. Leelarathna, L. N Engl J Med. (2022): DOI:10.1056/NEJMoa2205650.

17. Lameijer, A. Diabetes Res Clin Practice (2023). https://doi.org/10.1016/j.diabres.2023.110735.

 

ADC-2693412 v1.0 06/26