Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Flash Glucose Measurement in Patients on Total Parenteral Nutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03871660
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: FreeStyle Libre Pro Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: What Happens to Frequently Measured Glucose Measures in Patients, Both With and Without Diabetes, Who Are Receiving Total Parenteral Nutrition (TPN).
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Patients with diabetes on TPN
Glucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN.
Device: FreeStyle Libre Pro
Flash glucose monitoring device. Measures patients interstitial glucose levels continuously.

Patients without diabetes on TPN
Glucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN.
Device: FreeStyle Libre Pro
Flash glucose monitoring device. Measures patients interstitial glucose levels continuously.




Primary Outcome Measures :
  1. Hyperglycaemia [ Time Frame: 14 days ]
    Measurements of hyperglycaemia through interstitial glucose levels in patients on a TPN regime



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871660


Contacts
Layout table for location contacts
Contact: Michael W Mansfield, BM BCh, BA (hons) 01132066963 michael.mansfield@nhs.net

Locations
Layout table for location information
United Kingdom
Diabetes, Endocrinology and General Medcine Department St James Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact: Michael W Mansfield, BMBCh, BA (hons)    01132066963    michael.mansfield@nhs.net   
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust

Layout table for additonal information
Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03871660     History of Changes
Other Study ID Numbers: LeedsNHS
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Leeds Teaching Hospitals NHS Trust:
Total Parenteral Nutrition

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases