Diabetes and Palliative Care (DIAPAL)

April 13, 2016 updated by: Maison Médicale Jeanne Garnier

Comparison of Glycosuria and Capillary Blood Glucose in Hospitalised Diabetic Patients

Diabetes prevalence in palliative care is 10-15%. Most hospice patients are treated with insulin. The target glucose level is high in order to decrease the risk of hypoglycemia. Glucose level is usually monitored using capillary blood glucose once to three times daily.

The aim of the research is to simplify this pattern of care in end-of-life patients. It will evaluate whether the non invasive measurement of glucose in urine could replace the measurement of capillary blood glucose. The first objective will be to assess the performance of the measurement of glucosuria using urinary dip stix to predict that the blood glucose level is within the target range.

Due to the high glucose target, hyperglycemia is extremely frequent. However, symptoms of hyperglycemia are unfrequently reported. They may be unspecific and/or masked in end-of-life patients due to terminal disease and medication. The second objective of the study will be to define symptoms of hyperglycemia in these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study involving several palliative care units in France. Glycemia and glycosuria will be measured in the same patients. Symptoms that could be related to hyperglycemia will be assessed in relation with the concomitant blood glucose level.

Main investigations :

Glycosuria and cetonuria will be measured using a dip stix during each nursing care.

Glycemia will be measured before breakfast and before diner. Pain caused by finger pricking for the measurement of glycemia will be evaluated using a verbal scale.

Symptoms will be evaluated at the time of each glucose measurement first with open questions then with a list of potential symptoms of hyperglycemia.

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients hospitalised in a palliative care unit

Description

Inclusion Criteria:

  • diabetic patients
  • hospitalised in a palliative care unit
  • terminally ill with cancer
  • with blood glucose measurement at least twice daily over 5 days
  • agreeing to participate in the study

Exclusion Criteria:

  • patient unable to communicate, to understand information about the study or to decline participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive performance of glycosuria measured on urine collected between 10 am and 16 am on the blood glucose level at 6 pm
Time Frame: over 12 days

Glycosuria will be assessed using Ketodiabur 5000 urinary dip stix. The results are semi-quantitative with 8 levels of glycosuria ranging from 0% to 2% (weight/volume).

Capillary blood glucose level will be assessed using a glucose meter based on glucose oxydase.
over 12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between glycemia and glycosuria at different time points over 24 hours.
Time Frame: over 12 days
Glycemia and glycosuria will be assessed as described above.
over 12 days
Intensity of pain caused by finger pricking
Time Frame: 12 days
Intensity of pain will be assessed using a simple numerical scale.
12 days
Type, frequency and intensity of symptoms in relation to the blood glucose level
Time Frame: 12 days
Intensity of symptoms will be assessed using a simple numerical scale.
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maison Médicale Jeanne Garnier

Investigators

  • Principal Investigator: Frederic Guirimand, MD, Pôle Recherche Maison Médicale Jeanne Garnier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMJG/2014/SC/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on diagnosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe