FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes

This is an interventional treatment trial for Type 1 Diabetes Mellitus Read More

Inclusion Criteria:

- 1. The subject has documented T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least six month prior to study enrolment 2. Documented evidence should exist within the patient history of T1D 3. The subject is between six and 15 years of age (inclusive) at the time of enrolment 4. The subject has been treated with an insulin pump for at least 3 months 5. The subject has an A1C value between 6.3 and 10% (both inclusive) based on analysis from the local laboratory. A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.

6. The subject is willing to follow all study instructions 7. Subject is willing to perform daily self-monitoring of blood glucose (SMBG). 8. If subject has celiac/Hashimoto disease, the disease has to be adequately treated as determined by the investigator 9. Subject has a BMI above 5th centile and below 95th centile for age, respectively.

Exclusion Criteria:

• 1. Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical conditions, which in the investigator's opinion, may compromise patient safety; Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.

  2. Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder) 3. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids during the study.

  4. Subject is taking antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.

  5. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or Receipt of any investigational medical product within 1 month prior to screening.

  6. Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.

  7. Subject has known hypoglycemic unawareness or recurrent severe hypoglycemic events with seizure and/or coma (more than two episodes) within 6 months prior to screening.

  8. Subject has a history of one or more episodes of Diabetic Ketoacidosis (DKA) requiring hospitalization within a month prior to the screening.

  9. Subject has current or recent history of alcohol or drug abuse. 10. Subject has visual impairment or hearing loss, which in the investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit).