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NCT03871660 Clinical Trial

Flash Glucose Measurement in Patients on Total Parenteral Nutrition

Diabetes Mellitus Clinical Trial

Official title:
What Happens to Frequently Measured Glucose Measures in Patients, Both With and Without Diabetes, Who Are Receiving Total Parenteral Nutrition (TPN).

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03871660
Other study ID # LeedsNHS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date October 2019

Study information
Verified date May 2019
Source The Leeds Teaching Hospitals NHS Trust
Contact Michael W Mansfield, BM BCh, BA (hons)
Phone 01132066963
Email michael.mansfield@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

IV nutrition is a means of providing all the nutritional requirements of people who have severe bowel disease. At least 10% of people on longer term IV nutrition also have diabetes and IV nutrition includes delivering glucose directly to large veins. Unsurprisingly this causes elevated blood glucose levels, particularly in people with diabetes. This can make treatment of hyperglycaemia more challenging. As a result this study aims to use a flash glucose monitoring device, the FreeStyle Libre pro, to investigate what happens to glucose levels in patients receiving IV nutrition. We will look at this trend in 5 patients with diabetes and 5 patients without diabetes receiving IV nutrition.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Participants receiving TPN in Leeds with or without diabetes

Exclusion Criteria:

- Patients not receiving TPN

- Patients who do not speak English

- Patients who are unable to give consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• FreeStyle Libre Pro
Flash glucose monitoring device. Measures patients interstitial glucose levels continuously.

Locations
Country Name City State
United Kingdom Diabetes, Endocrinology and General Medcine Department St James Hospital Leeds West Yorkshire

Sponsors (1)
Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hyperglycaemia Measurements of hyperglycaemia through interstitial glucose levels in patients on a TPN regime 14 days
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