End-of-lifeDIAPALNCT02742701
Diabetes and Palliative Care
An observational study of End-of-life and Diabetes, run by Maison Médicale Jeanne Garnier.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-of-life, Diabetes, Terminal Cancer
- What is being tested?
- diagnosis
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalised in a palliative care unit
Who may be able to join
- 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
Who cannot join
- patient unable to communicate, to understand information about the study or to decline participation in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Glycosuria and Capillary Blood Glucose in Hospitalised Diabetic Patients
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.
Read the 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.
- Conditions
- End-of-life, Diabetes, Terminal Cancer
- Being tested
- diagnosis
- Medical subject headings
- Death, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosisOther
Measurement of glycosuria
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 12 days
Secondary outcomes (3)
Relation between glycemia and glycosuria at different time points over 24 hours.
Glycemia and glycosuria will be assessed as described above.
Measured: over 12 days
Intensity of pain caused by finger pricking
Intensity of pain will be assessed using a simple numerical scale.
Measured: 12 days
Type, frequency and intensity of symptoms in relation to the blood glucose level
Intensity of symptoms will be assessed using a simple numerical scale.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-of-lifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maison Médicale Jeanne Garnier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Guirimand, MD, Principal investigator, Pôle Recherche Maison Médicale Jeanne Garnier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742701
- Sponsor's protocol ID
- MMJG/2014/SC/001
- Acronym
- DIAPAL
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glycosuria and Capillary Blood Glucose in Hospitalised Diabetic Patients
- ClinicalTrials.gov ID
- NCT02742701
- Acronym / sponsor ID
- DIAPAL / MMJG/2014/SC/001
- Conditions
- End-of-life, Diabetes, Terminal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Maison Médicale Jeanne GarnierUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised in a palliative care unit
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- patient unable to communicate, to understand information about the study or to decline participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosisMeasurement of glycosuria | Other | – |
Primary outcome
Predictive performance of glycosuria measured on urine collected between 10 am and 16 am on the blood glucose level at 6 pm
Time frame: 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.
3 secondary outcomes
Relation between glycemia and glycosuria at different time points over 24 hours.
Time frame: over 12 days
Intensity of pain caused by finger pricking
Time frame: 12 days
Type, frequency and intensity of symptoms in relation to the blood glucose level
Time frame: 12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Guirimand, MD principal investigator
Pôle Recherche Maison Médicale Jeanne Garnier
Questions about this trial
What is this clinical trial studying?
An observational study of End-of-life and Diabetes, run by Maison Médicale Jeanne Garnier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Francillard, MD (00 33 (6) 09 91 45 05, marie.francillard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performance of glycosuria measured on urine collected between 10 am and 16 am on the blood glucose level at 6 pm (time frame: over 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.