Insulin Glargine Vs Standard Insulin Therapy
Cystic Fibrosis Related Diabetes
About this trial
This is an interventional treatment trial for Cystic Fibrosis Related Diabetes focused on measuring Cystic Fibrosis, Diabetes
Eligibility Criteria
Inclusion Criteria CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl) . The diagnosis must be made at a time when the patient is in his/her basal state of health with no evidence of acute exacerbation in the preceding two months. a). Acute exacerbation is defined on page 9. . For patients with onset of diabetes in the preceding 6 months, the hemoglobin A1c must be stable for 3 months prior to study entrance within 5% (0.3% A1c increment). Age ≥18, post-pubertal (done growing, since change in weight is a study endpoint) Weight stable within 5% during the previous 3 months as measured in CF clinic Willingness to attend all study visits and to engage in regular phone or e-mail contact with the study diabetes nurse Glucocorticoids can have a profound effect on weight, and thus we wish to minimize the occurrence of changing steroid doses during the study period. Patients receiving glucocorticoid therapy will be included in the protocol only if: . They have been on the same steroid dose for the preceding six months, . There are no plans to change their steroid dose in the next eight months. Exclusion Criteria Pregnancy or plans to become pregnant in the next eight months (because of the changes pregnancy would cause in our study endpoints), Unwillingness / inability to take multiple injections or to count carbohydrates, A history of hypoglycemia unawareness (rare in CF), Plans to start any medication in the next 8 months that might affect weight, such as testosterone or Megace. Patients chronically taking these medications may be included if: . They have been on the same dose for the preceding six months . There are no plans to change their dose in the next eight months
Sites / Locations
- University of Minnesota