Diabetes and Palliative Care | NCT02742701

Studies
Diabetes and Palliative Care

NCT02742701

Sponsor

Maison Médicale Jeanne Garnier

Status

Unknown status

Last Update Posted

Apr 19, 2016Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

End-of-life
Diabetes
Terminal Cancer

Interventions

diagnosis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Apr 7, 2016

First Submission Date that Met QC Criteria

Apr 13, 2016

First Posted Date

Apr 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2016

Last Update Posted Date

Apr 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Name	Type	Description	Arm Group Labels	Other Names
diagnosis	Other	Measurement of glycosuria

Outcomes Module

Primary Outcomes

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	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

Measure	Description	Time Frame
Relation between glycemia and glycosuria at different time points over 24 hours.	Glycemia and glycosuria will be assessed as described above.	over 12 days
Intensity of pain caused by finger pricking

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalised in a palliative care unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marie Francillard, MD	Contact	00 33 (6) 09 91 45 05		marie.francillard@gmail.com

Overall Officials

Name	Affiliation	Role
Frederic Guirimand, MD	Pôle Recherche Maison Médicale Jeanne Garnier	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

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Browse Branches

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