Status:
COMPLETED
Managing Insulin Pumps for Exercise - Study 1
Lead Sponsor:
Buckinghamshire Healthcare NHS Trust
Collaborating Sponsors:
Animas Corporation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Brief Summary
People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer th...
Detailed Description
For the first part of the study, participants will be either people with type 1 diabetes treated with insulin pump therapy or volunteers without diabetes. The 2 groups will be matched as far as possib...
Eligibility Criteria
Inclusion
- For participants with Type 1 Diabetes Mellitus
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 65 years
- Diagnosed with Type 1 diabetes mellitus
- Treated with CSII for at least 3 months
- Exercises regularly for more than 1 hour per week
- For participants without Type 1 Diabetes Mellitus
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged between 18 and 65 years
- Exercises regularly for more than 1 hour per week
Exclusion
- For participants with type 1 Diabetes Mellitus
- People with any one of the following complications of diabetes:
- stage 2+ diabetic retinopathy
- renal impairment (with creatinine \>150micromol/l)
- known history or symptoms of cardiovascular disease
- foot ulceration
- peripheral vascular disease
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
- For participants without Type 1 Diabetes Mellitus
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Diagnosis of impaired fasting glucose, impaired glucose tolerance or diabetes mellitus
- Treatment with drugs known to interfere with glucose metabolism
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01401127
Start Date
January 1 2011
End Date
August 1 2011
Last Update
November 8 2011
Active Locations (1)
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1
Wycombe Hospital
High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT