Diabetes and Palliative Care

• Conditions: Terminal Cancer; End-of-life; Diabetes

• Registration Number: NCT02742701
• Lead Sponsor: Maison Médicale Jeanne Garnier

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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-13
• Last Update Submitted: 2016-04-13
• Study First Posted: 2016-04-19
• Last Update Posted: 2016-04-19
• Primary Completion: 2017-10
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive performance of glycosuria measured on urine collected between 10 am and 16 am on the blood glucose level at 6 pm	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.

Secondary Outcome Measures

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