Cystic Fibrosis Related Diabetes (CFRD) MedDRA version: 14.1 Level: LLT Classification code 10022468 Term: Insulin System Organ Class: 100000004848
Conditions
Interventions
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Product Name: Levemir FlexPen
Pharmaceutical Form: Solution for injection in pre-filled pen
Sponsors
Liverpool Heart and Chest Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female with a confirmed diagnosis of cystic fibrosis defined by a) Clinical features consistent with a diagnosis of CF AND b) Sweat chloride =60mmol/L by pilocarpine ionotophoresis; OR c) Genotypic confirmation of CFTR mutation 2. Aged 18 – 50 years 3. Outpatients from the regional adult unit in Liverpool 4. Currently not on insulin 5. Clinically stable over the preceding 4 weeks i.e. no indication for iv antibiotics, steroids or hospital admissions 6. CGM result: At least 4.5% of time spent =7.8 % (This indicates altered glucose handling implying insulin insufficiency) Are the trial subjects under 18? no 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients on glucose lowering medications (insulin, oral agents) 2. Ongoing acute illness 3. Those on long term oral steroids 4. Pregnant women 5. Those on immunosuppressive treatment 6. History of, or planned organ transplant 7. Known clinically significant abnormal findings on haematology or clinical chemistry 8. Subjects with documented or suspected, clinically significant, alcohol or drug abuse. The determination of clinical significance will be determined by the investigator. 9. Current malignant disease 10. Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There is a body of evidence in Type 1 and Type 2 Diabetes that “resting” the pancreas by giving insulin in the early stages of the disease allows the pancreatic beta cells to recover, thereby delaying progression of disease. This has not been looked at in CF and our study aims to test this. Hence, the main objective of this study is to test the folowing hypothesis: Supplementation with small doses of insulin in individuals with CF and altered glucose tolerance leads to an improvement in the first phase responses in beta-cell functioning;Secondary Objective: 1. To study whether supplementation of insulin deficient CF patients, with small doses of insulin, leads to an increase in ß-cell sensitivity in the dynamic state 2. To evaluate if beta-cell rest improves the overall glycaemic profile in an individual with CF and the duration this is sustained for? ;Primary end point(s): This is an observational physiological study. Completion of whole study, change of clinical status between or during the study days, commencement of insulin for a clinical need, patient withdrawing consent or death. ;Timepoint(s) of evaluation of this end point: Day 97 of study protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United Kingdom
Contacts
Public ContactDr Martin Walshaw
Liverpool Heart and Chest Hospital NHS Trust
Outcome results
None listed