DiabetesONCODIABNCT04315857
Study on Glycemic Variations in Diabetic Patients Treated With Chemotherapy: Benefit of Continuous Interstitial Glucose Measurement
An observational study of Diabetes and Chemotherapy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Over the last years, there has been a progressive increase in the prevalence of diabetes. Approximately 3.3 million French adults and approximately 425 million adults worldwide have been diagnosed with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Chemotherapy, Interstitial Glycemia
- What is being tested?
- interstitial glycaemia
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2020to 6 Apr 2022
- 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: diabetic patients starting chemotherapy
Who may be able to join
- Person who has provided oral consent
- Diabetic cancer patient starting chemotherapy for the first time or after a period of remission of at least 6 months.
Who cannot join
- Person not affiliated to French National Health Insurance
- Person subject to legal protection (guardianship, trusteeship)
- Person subject to partial justice safeguard measure
- Pregnant, parturient or breastfeeding woman
- Adult unable to provide consent
- Minor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on Glycemic Variations in Diabetic Patients Treated With Chemotherapy: Benefit of Continuous Interstitial Glucose Measurement
Over the last years, there has been a progressive increase in the prevalence of diabetes. Approximately 3.3 million French adults and approximately 425 million adults worldwide have been diagnosed with diabetes. Because of the associated high morbiditiy and mortality, this chronic disease is at the heart of public health discussions, and technologies to improve its management are constantly progressing.
One notable innovation is the Freestyle Free blood glucose meter, which enables the continuous measurement of interstitial blood glucose levels. This type of device has enabled diabetic patients to refine their blood glucose monitoring and improve the balance of their diabetes, while reducing the associated constraints.
Read more
To date, the Freestyle Libre meter is only available in patients treated with insulin pumps or multi-injections (at least 3 insulin injections per day) due to the risk of significant blood glucose variations. However, one can imagine other situations where the Freestyle Libre could be of interest to detect significant glycemic imbalances, such as in diabetic patients with cancer treated with chemotherapy.
To our knowledge, no study has been conducted on the relationship between chemotherapy and glycemic balance.
A few studies have looked at the balance of diabetes and chemotherapy in combination with corticosteroid therapy, but the analyses were based on fasting blood glucose levels, or some capillary blood glucose levels, or glycated hemoglobin - which can be deficient due to toxic treatments at the bone marrow level with variations in erythropoiesis. Hypoglycemia facilitated by anorexia (related to cancer and chemotherapy) or hyperglycemia facilitated by hyperglycemic drugs can be severe for patients with high care utilization and associated significant cost.
However, other studies have looked at the consequences of unbalanced diabetes in the context of cancer treated with chemotherapy. The results showed that hyperglycemia could lead to an increased risk of toxicity and side effects of chemotherapy. In addition, the choice of chemotherapy type or dosage may be different from a non-diabetic patient, which may result in a reduced remission and/or cure rate.
These results are then in contradiction with common practice, as the presence of cancer often leads doctors to be less rigorous in controlling blood sugar levels.
As the prevalence of diabetes in patients newly diagnosed with cancer is quite high (between 8 and 18% depending on the study) and because it is likely to continue to increase with the increasing prevalence of diabetes, particularly type 2 diabetes, closer monitoring of blood glucose levels in diabetic patients appears to be essential in the overall management of the patient.
In our study, we therefore focused on the continuous interstitial glycemia of diabetic patients entering the Ambulatory Medical Unit of Cancerology to start chemotherapy related to their cancer, be it hematological, digestive, cutaneous or gynecological.
- Conditions
- Diabetes, Chemotherapy, Interstitial Glycemia, Freestyle
- Being tested
- interstitial glycaemia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interstitial glycaemiaOther
Continuous measurement of interstitial blood glucose during the first 15 days of the first two chemotherapy courses.
| Study group | Role | What they receive |
|---|---|---|
| diabetics | diabetics receiving chemotherapy for cancer Receives: Other: interstitial glycaemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent with an interstitial blood glucose level below 0.70 g/l and above 2.5 g/l
Measured: Through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start9 Jun 2020
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315857
- Sponsor's protocol ID
- PETIT 2019
- Acronym
- ONCODIAB
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Legris P, Bouillet B, Paris J, Pistre P, Devaux M, Bost S, Simoneau I, Manfredi S, Drouillard A, Bastie JN, Chaix M, Massoud P, Rouland A, Aho S, Boulin M, Petit JM. Glycemic control in people with diabetes treated with cancer chemotherapy: contribution of continuous glucose monitoring. Acta Diabetol. 2023 Apr;60(4):545-552. doi: 10.1007/s00592-023-02032-z. Epub 2023 Jan 13.
PubMed 36637528
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Glycemic Variations in Diabetic Patients Treated With Chemotherapy: Benefit of Continuous Interstitial Glucose Measurement
- ClinicalTrials.gov ID
- NCT04315857
- Acronym / sponsor ID
- ONCODIAB / PETIT 2019
- Conditions
- Diabetes, Chemotherapy, Interstitial Glycemia, Freestyle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 20 Mar 2020 (actual)
- 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.
Over the last years, there has been a progressive increase in the prevalence of diabetes. Approximately 3.3 million French adults and approximately 425 million adults worldwide have been diagnosed with diabetes. Because of the associated high morbiditiy and mortality, this chronic disease is at the heart of public health discussions, and technologies to improve its management are constantly progressing.
One notable innovation is the Freestyle Free blood glucose meter, which enables the continuous measurement of interstitial blood glucose levels. This type of device has enabled diabetic patients to refine their blood glucose monitoring and improve the balance of their diabetes, while reducing the associated constraints.
To date, the Freestyle Libre meter is only available in patients treated with insulin pumps or multi-injections (at least 3 insulin injections per day) due to the risk of significant blood glucose variations. However, one can imagine other situations where the Freestyle Libre could be of interest to detect significant glycemic imbalances, such as in diabetic patients with cancer treated with chemotherapy.
To our knowledge, no study has been conducted on the relationship between chemotherapy and glycemic balance.
A few studies have looked at the balance of diabetes and chemotherapy in combination with corticosteroid therapy, but the analyses were based on fasting blood glucose levels, or some capillary blood glucose levels, or glycated hemoglobin - which can be deficient due to toxic treatments at the bone marrow level with variations in erythropoiesis. Hypoglycemia facilitated by anorexia (related to cancer and chemotherapy) or hyperglycemia facilitated by hyperglycemic drugs can be severe for patients with high care utilization and associated significant cost.
However, other studies have looked at the consequences of unbalanced diabetes in the context of cancer treated with chemotherapy. The results showed that hyperglycemia could lead to an increased risk of toxicity and side effects of chemotherapy. In addition, the choice of chemotherapy type or dosage may be different from a non-diabetic patient, which may result in a reduced remission and/or cure rate.
These results are then in contradiction with common practice, as the presence of cancer often leads doctors to be less rigorous in controlling blood sugar levels.
As the prevalence of diabetes in patients newly diagnosed with cancer is quite high (between 8 and 18% depending on the study) and because it is likely to continue to increase with the increasing prevalence of diabetes, particularly type 2 diabetes, closer monitoring of blood glucose levels in diabetic patients appears to be essential in the overall management of the patient.
In our study, we therefore focused on the continuous interstitial glycemia of diabetic patients entering the Ambulatory Medical Unit of Cancerology to start chemotherapy related to their cancer, be it hematological, digestive, cutaneous or gynecological.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetics | – | Other: interstitial glycaemiadiabetics receiving chemotherapy for cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients starting chemotherapy
Key inclusion criteria (2 listed)
- Person who has provided oral consent
- Diabetic cancer patient starting chemotherapy for the first time or after a period of remission of at least 6 months.
Key exclusion criteria (6 listed)
- Person not affiliated to French National Health Insurance
- Person subject to legal protection (guardianship, trusteeship)
- Person subject to partial justice safeguard measure
- Pregnant, parturient or breastfeeding woman
- Adult unable to provide consent
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 |
|---|---|---|
| interstitial glycaemiaContinuous measurement of interstitial blood glucose during the first 15 days of the first two chemotherapy courses. | Other | diabetics |
Primary outcome
Time spent with an interstitial blood glucose level below 0.70 g/l and above 2.5 g/l
Time frame: Through study completion, an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 36637528Legris P, Bouillet B, Paris J, Pistre P, Devaux M, Bost S, Simoneau I, Manfredi S, Drouillard A, Bastie JN, Chaix M, Massoud P, Rouland A, Aho S, Boulin M, Petit JM. Glycemic control in people with diabetes treated with cancer chemotherapy: contribution of continuous glucose monitoring. Acta Diabetol. 2023 Apr;60(4):545-552. doi: 10.1007/s00592-023-02032-z. Epub 2023 Jan 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Chemotherapy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent with an interstitial blood glucose level below 0.70 g/l and above 2.5 g/l (time frame: Through study completion, an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315857, which also lists 1 linked publication.
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 2 Feb 2026.