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. 2016 Apr 13;10(3):754–761. doi: 10.1177/1932296816642578

Table 1.

Inclusion and Exclusion Criteria in the CGM-MDI Trial.

Inclusion criteria
1. Type 1 diabetes.
2. Adults 18 years or older.
3. Written informed consent.
4. HbA1c greater than or equal to 7.5% (58 mmol/mol).
Exclusion criteria
1. Pregnancy, planned pregnancy for the study duration, or pregnancy during the past 6 months.
2. Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion.
3. Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the Dexcom G4. However, other pain killers can be used throughout the study duration.
4. Current CGM use (within the past 4 months).
5. History of allergic reaction to any of the CGMS materials or adhesives in contact with the skin.
6. History of allergic reaction to chlorhexidine or alcohol antiseptic solution.
7. Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
8. Patient is uncomfortable by using the sensor during the blinded run-in period and believes it is unlikely that he or she will use the sensor more than 80% of the time during the trial.
9. The patient has on average performed 12 or fewer calibrations per week during the run-in period.
10. Insulin pump therapy = CSII.
11. Diabetes duration < 1 year.
12. Participation in another study.
13. Fasting C-peptide level of 0.3 mmol/l or higher.
14. Other investigator-determined criteria making patients unsuitable for participation.
15. eGFR < 30 ml/min (estimated from creatinine, age, and sex at the inclusion visit by the MDRD-formula).
16. Planned house move during the next 1.5 years, making it difficult to come to study visits.