Flash Glucose Measurement in Patients on Total Parenteral Nutrition
What Happens to Frequently Measured Glucose Measures in Patients, Both With and Without Diabetes, Who Are Receiving Total Parenteral Nutrition (TPN).
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Mar 2019
Shorter than P25 for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedMay 28, 2019
May 1, 2019
7 months
February 21, 2019
May 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hyperglycaemia
Measurements of hyperglycaemia through interstitial glucose levels in patients on a TPN regime
14 days
Study Arms (2)
Patients with diabetes on TPN
OTHERGlucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN.
Patients without diabetes on TPN
OTHERGlucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN.
Interventions
Flash glucose monitoring device. Measures patients interstitial glucose levels continuously.
Eligibility Criteria
You may qualify if:
- Participants receiving TPN in Leeds with or without diabetes
You may not qualify if:
- Patients not receiving TPN
- Patients who do not speak English
- Patients who are unable to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes, Endocrinology and General Medcine Department St James Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2019
First Posted
March 12, 2019
Study Start
March 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
May 28, 2019
Record last verified: 2019-05