Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes.
Conditions
Interventions
Product Name: Levemir Penfill
Pharmaceutical Form: Solution for injection
Sponsors
Sheffield Children's NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any individual with cystsic fibrosis aged 10 years or older who has impaired glucose tolerance following a standard oral glucose tolerance test (OGTT): - fasting glucose >6.1 mmol but 7.8mmol but 1.1mmol but non diabetic OGTT Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Failure to give informed consent Previous treatment with insulin or hypoglycaemic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To identify aspects of abnormal glucose handling and beta cell function that predict future diabetes. ; Primary end point(s): 1) Change in lung function (FEV1, FVC, Shwachmann score) 2) Change in BMI standard deviation score and growth velocity ; Main Objective: To examine whether treatment with a long acting insulin analogue in the prediabetic phase improves growth & lung function and whether it delays progression to the development of overt diabetes in cystic fibrosis | — |
Countries
United Kingdom
Outcome results
None listed