Diabetes and Palliative Care
DIAPAL
Comparison of Glycosuria and Capillary Blood Glucose in Hospitalised Diabetic Patients
1 other identifier
observational
180
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
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
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 7, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedApril 19, 2016
April 1, 2016
1.5 years
April 7, 2016
April 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Predictive performance of glycosuria measured on urine collected between 10 am and 16 am on the blood glucose level at 6 pm
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 Outcomes (3)
Relation between glycemia and glycosuria at different time points over 24 hours.
over 12 days
Intensity of pain caused by finger pricking
12 days
Type, frequency and intensity of symptoms in relation to the blood glucose level
12 days
Interventions
Measurement of glycosuria
Eligibility Criteria
Patients hospitalised in a palliative care unit
You may qualify if:
- 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
You may not qualify if:
- patient unable to communicate, to understand information about the study or to decline participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic Guirimand, MD
Pôle Recherche Maison Médicale Jeanne Garnier
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2016
First Posted
April 19, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2017
Study Completion
January 1, 2018
Last Updated
April 19, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share