The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).

There are two multicentre prospective cohort studies within the glycaemic deterioration work package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic deterioration by amassing data and biomaterials that will be used to discover novel biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes (Study 1) and in those who have recently been diagnosed with the disease (Study 2).

Study 1

Inclusion criteria

• No treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs
• Fasting capillary blood glucose <10 mmol/l at baseline
• White European (self-report of parental ethnicity)
• Age ≥35 and <75 years

Exclusion criteria

• Diagnosed diabetes of any type, HbA1c ≥6.5% (48 mmol/mol) or fasting plasma glucose ≥7.0 mmol/l or 2 h plasma glucose >11.0 mmol/l previously
• For women, pregnancy, lactation or plans to conceive within the study period
• Use of a pacemaker
• Any other significant medical reason for exclusion as determined by the investigator

Study 2

Inclusion Criteria:

• Patients diagnosed with type 2 diabetes not less than 6 months and not more than 24 months before baseline examination
• Management by lifestyle with or without metformin therapy
• All HbA1c <7.6% (<60 mmol/mol) within previous 3 months
• White European
• Age ≥35 and <75
• Estimated GFR >50 ml/min'

Exclusion Criteria:

• Type 1 diabetes

  • A previous HbA1c >9.0% (>75 mmol/mol)
  • Prior treatment with insulin or an oral hypoglycaemic agent other than metformin
  • BMI <20 or >50 kg/m2
  • Pregnancy, lactation or plans to conceive within the study period
  • Any other significant medical reason for exclusion as determined by the investigator

White European (self-report of parental ethnicity), Age ≥35 and <75 years