Register study to assess validity of eA1c versuns HbA1c in patients with Diabetes mellitus using flash glucose monitoring

Register study to assess validity of eA1c versuns HbA1c in patients with Diabetes mellitus using flash glucose monitoring - eA1c_Register

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013667

Enrollment

1000

Registered

2018-04-10

Start date

2017-11-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10 E11

Interventions

Group 1: As part of a routine visit in the diabetes outpatient clinic, the glucose data from the last 3 months of the Abbott Freestyle Libre device are read and the calculated HbA1c is compared to the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Diabetes mellitus diagnosed for at least 1 year • Male or female, age =18 years • Insulin pump or multiple daily injection regimen for at least 6 months • The subject is routinely using flash glucose monitoring (FGM) and has a FGM cov-erage of 80% of time • No existing pregnancy, birth or abortion within the last 3 months

Exclusion criteria

Exclusion criteria: • Cognitive dysfunction rendering the patient incapable of signing the informed consent

Design outcomes

Primary

Measure	Time frame
To assess whether eA1c as a valid marker of glycemic control compared to HbA1c	—

Secondary

Measure	Time frame
• To assess the impact of hypoglycaemic (180mg/dl) on eA1c vs. HbA1c. • To assess the impact of haemoglobinopathies on eA1c vs. HbA1c. • To assess the impact of kidney function on eA1c vs. HbA1c. • Link between participants’ reaction to hypoglycaemia 1 and 2 / hyperglycaemia 1 & 2 (scan, carbohydrate consumption, insulin injection) and impaired awareness of hypoglycaemia (routine questionnaires) • Assessment of time in glycaemic ranges in relation to standard recommendations	—

Measure

Time frame

• To assess the impact of hypoglycaemic (180mg/dl) on eA1c vs. HbA1c. • To assess the impact of haemoglobinopathies on eA1c vs. HbA1c. • To assess the impact of kidney function on eA1c vs. HbA1c. • Link between participants’ reaction to hypoglycaemia 1 and 2 / hyperglycaemia 1 & 2 (scan, carbohydrate consumption, insulin injection) and impaired awareness of hypoglycaemia (routine questionnaires) • Assessment of time in glycaemic ranges in relation to standard recommendations

—

Countries

Austria

Contacts

Public ContactJulia Mader

Medizinische Universität Graz

julia.mader@medunigraz.at+43 316 385 82382

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026