Diabetes MellitusNCT03871660
Flash Glucose Measurement in Patients on Total Parenteral Nutrition
A study testing FreeStyle Libre Pro in people with Diabetes Mellitus, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FreeStyle Libre Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2019to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants receiving TPN in Leeds with or without diabetes
Who cannot join
- Patients not receiving TPN
- Patients who do not speak English
- Patients who are unable to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Diabetes, Endocrinology and General Medcine Department St James Hospital
Leeds, West Yorkshire, LS9 7TF
Michael W Mansfield, BMBCh, BA (hons), 01132066963, michael.mansfield@nhs.net
About this study
Official title: What Happens to Frequently Measured Glucose Measures in Patients, Both With and Without Diabetes, Who Are Receiving Total Parenteral Nutrition (TPN).
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.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Libre Pro
- Keywords
- Total Parenteral Nutrition
- Medical subject headings
- Diabetes Mellitus, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre ProDevice
Flash glucose monitoring device. Measures patients interstitial glucose levels continuously.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes on TPN | Other | Glucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN. Receives: Device: FreeStyle Libre Pro |
| Patients without diabetes on TPN | Other | Glucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN. Receives: Device: FreeStyle Libre Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperglycaemia
Measurements of hyperglycaemia through interstitial glucose levels in patients on a TPN regime
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Mar 2019
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871660
- Sponsor's protocol ID
- LeedsNHS
- Status last verified
- May 2019
- First submitted
- 21 Feb 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Happens to Frequently Measured Glucose Measures in Patients, Both With and Without Diabetes, Who Are Receiving Total Parenteral Nutrition (TPN).
- ClinicalTrials.gov ID
- NCT03871660
- Acronym / sponsor ID
- LeedsNHS
- Conditions
- Diabetes Mellitus
- Keywords
- Total Parenteral Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes on TPN | Other | Device: FreeStyle Libre ProGlucose 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 | Other | Device: FreeStyle Libre ProGlucose levels will be monitored using the FreeStyle Libre devices over a 14 day period. In this time the patient will receive TPN. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants receiving TPN in Leeds with or without diabetes
Key exclusion criteria (3 listed)
- Patients not receiving TPN
- Patients who do not speak English
- Patients who are unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Libre ProFlash glucose monitoring device. Measures patients interstitial glucose levels continuously. | Device | Patients with diabetes on TPN, Patients without diabetes on TPN |
Primary outcome
Hyperglycaemia
Time frame: 14 days
Measurements of hyperglycaemia through interstitial glucose levels in patients on a TPN regime
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre Pro in people with Diabetes Mellitus, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael W Mansfield, BM BCh, BA (hons) (01132066963, michael.mansfield@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperglycaemia (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.