Diabetes and Palliative Care

NCT ID: NCT02742701

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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End-of-life Diabetes Terminal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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diagnosis

Measurement of glycosuria

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maison Médicale Jeanne Garnier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic Guirimand, MD

Role: PRINCIPAL_INVESTIGATOR

Pôle Recherche Maison Médicale Jeanne Garnier

Central Contacts

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Marie Francillard, MD

Role: CONTACT

00 33 (6) 09 91 45 05

Other Identifiers

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MMJG/2014/SC/001

Identifier Type: -

Identifier Source: org_study_id

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