Trial document





This trial has been registered retrospectively.
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  DRKS00013667

Trial Description

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Title

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

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Trial Acronym

eA1c_Register

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this register study is to evaluate validity of eA1c in contrast to HbA1c to assess overall glycemic control in patients using routinely flash glucose Monitoring.

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Brief Summary in Scientific Language

Diabetes mellitus is a chronic disease requiring frequent blood glucose monitoring to establish good glycaemic control. Achievement of good glycaemic control is associated with improved outcome in patients with diabetes mellitus. Glycaemic control is not only influenced by the correct dosing, adequate timing and predictable absorption of insulin but also largely depends on meals (content, size, absorption), exercise, illness to name the most relevant. Due to the complexity of insulin therapy a large proportion of diabetes patients do not achieve glycaemic goals or suffer from treatment-emergent hypoglycaemia even if they are using currently marketed modern insulins or technological gadgets such as insulin pumps, bolus calculators or diabetes apps.

Recent studies proved that more precise continuous glucose monitoring (CGM) systems are effective in reducing HbA1c and the burden of hypoglycaemia. Recently a new variant of continuous glucose monitoring has become available – the so-called flash glucose monitoring. In contrast to conventional continuous glucose monitoring where a constant glucose signal is available and the patient is alarmed in case of hypo- or hyperglycaemia, flash glucose monitoring requires more interaction by the patient who actively needs to scan for obtaining data. Additionally, no alarm features are available. However, in randomized controlled studies a reduction in hypoglycaemia by maintaining stable HbA1c levels was observed . Due to the quasi continuous glucose signal, also average glycaemia, the so-called eA1c (electronic HbA1c) is calculated automatically. HbA1c in contrast might be largely influenced by hypo- and hyperglycaemic excursions and also haemoglobinopathies. Therefore, eA1c might be a more robust marker of glycaemic control. Within this register study, the correlation between eA1c and HbA1c as well as routine laboratory parameters (haemoglobin level, renal function) as well as hypo- and hyperglycaemic excursions will be investigated in patients with diabetes mellitus routinely using FGM.
With the protocolamendment from the protocol Version 2.0. the link between participants’ reaction to hypoglycaemia 1 and 2 / hyperglycaemia 1 & 2 (scan, carbohydrate consumption, insulin injection) and the impaired awareness of hypoglycaemia (routine questionnaires) will also be investigated. As well the effect of time in glycaemic ranges in relation to standard recommendation.

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Organizational Data

  •   DRKS00013667
  •   2018/04/10
  •   [---]*
  •   yes
  •   Approved
  •   29-522 ex 16/17, Ethikkommission der Medizinischen Universität Graz LKH-Universitätsklinikum - Eingangsgebäude Auenbruggerplatz 2, 3.OG 8036 Graz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E10 -  Type 1 diabetes mellitus
  •   E11 -  Type 2 diabetes mellitus
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Interventions/Observational Groups

  •   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 real measured HbaA1c from a laboratory measurement.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

To assess whether eA1c as a valid marker of glycemic control compared to HbA1c

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Secondary Outcome

• To assess the impact of hypoglycaemic (<70mg/dl) on eA1c vs. HbA1c.
• To assess the impact of hyperglycaemic (>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

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/02
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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Exclusion Criteria

• Cognitive dysfunction rendering the patient incapable of signing the informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Universität Graz
    • Ms.  Ass. Prof. Dr.  Julia  Mader 
    • Auenbruggerplatz 2
    • 8036  Graz
    • Austria
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    • Medizinische Universität Graz
    • Ms.  Ass. Prof. Dr.  Julia  Mader 
    • Auenbruggerplatz 2
    • 8036  Graz
    • Austria
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    • Medizinische Universität Graz
    • Ms.  Ass. Prof. Dr.  Julia  Mader 
    • Auenbruggerplatz 2
    • 8036  Graz
    • Austria
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Sources of Monetary or Material Support

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    • Universitätsklinikum für Innere Medizin Klinische Abteilung für Endokrinologie & Diabetologie
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   eA1c EK-Votum
  •   eA1c Protokoll
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* This entry means the parameter is not applicable or has not been set.