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A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis

A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71877586
Enrollment
240
Registered
2007-06-27
Start date
2006-10-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis Related Diabetes mellitus (CFRD) Nutritional, Metabolic, Endocrine Diabetes mellitus

Interventions

Children will be randomised to receive Insulin detemir 0.2 units per kg body weight by once daily subcutanous injection daily for one year. The control group will receive no intervention. There is no

Sponsors

Sheffield Children's NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Any child over ten years of age with either fasting plasma glucose more than 6.1 mmol/l but less than 7.0 mmol/l and/or a two hour glucose of more than 7.8 mmol/l but less than 11.1 mmol/l.

Exclusion criteria

Exclusion criteria: 1. Failure to provide informed consent 2. Pre-existing insulin or oral hypoglycaemic agent treatment

Design outcomes

Primary

MeasureTime frame
Measurements of beta-cell function

Secondary

MeasureTime frame
1. Height, weight, Body Mass Index (BMI), triceps and biceps skin fold thickness 2. Respiratory function testing 3. Three monthly glycosylated haemoglobin 4. Adverse event monitoring

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026