Clinical trial NCT02742701: Diabetes and Palliative Care
Official title: Comparison of Glycosuria and Capillary Blood Glucose in Hospitalised Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-of-life
Diabetes
Terminal Cancer
Lead sponsor: Maison Médicale Jeanne Garnier
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised in a palliative care unit

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive performance of glycosuria measured on urine collected between 10 am and 16 am on the blood glucose level at 6 pm
timeFrame: over 12 days
Secondary outcomes:
measure: Relation between glycemia and glycosuria at different time points over 24 hours.
timeFrame: over 12 days
measure: Intensity of pain caused by finger pricking
timeFrame: 12 days
measure: Type, frequency and intensity of symptoms in relation to the blood glucose level
timeFrame: 12 days
Other outcomes:
Locations:
Study officials:
affiliation: Pôle Recherche Maison Médicale Jeanne Garnier
name: Frederic Guirimand, MD
role: PRINCIPAL_INVESTIGATOR
References: