Diabete MellitusDIABETE COACHNCT06167499
Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy
A study testing Diabetes Therapeutic Education conducted by nurses in people with Diabete Mellitus and Insulin Dependent Diabetes, run by Hopital Nord Franche-Comte at 1 site in France.
Trial summary
Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabete Mellitus, Insulin Dependent Diabetes
- What is being tested?
- Diabetes Therapeutic Education conducted by nurses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2024to 1 Mar 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman or man aged 18 to 75
- Diabetic patient type 1 or 2 insulin-dependent
- Patient treated with multi-injections or insulin pump
- Patient equipped with FreeStyle Libre flash glucose monitoring system
- Glycemic imbalance with HBA1c > 8
- Patient living at home
Who cannot join
- Recent discovery (< 6 months) of diabetes
- Major intellectual disability
- Social isolation
- IMC > 35
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Therapeutic Education Consultations Conducted by Specialized Nurses on Glycemic Control and Quality of Life in Diabetic Patients Treated With Intensified Insulin Therapy: a Randomized Study
Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose.
All these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses.
The aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. The objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.
- Conditions
- Diabete Mellitus, Insulin Dependent Diabetes
- Being tested
- Diabetes Therapeutic Education conducted by nurses
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Therapeutic Education conducted by nursesOther
Individual consultations with the therapeutic education IDE, who will help the patient to achieve the therapeutic objectives set before the medical consultation.
Once the objectives have been set, the IDE will set up individual workshops and subsequently assess the patient's learning and its impact on his or her care. These workshops can include equipment demonstrations and practical exercises, explanations of treatment adaptation protocols, and dietary or sexual advice.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Education Group. | Experimental | Medical follow-up every 6 months for 18 months (inclusion, M6, M12, M18) associated with therapeutic education consultations conducted by nurses in the month following inclusion (between D0 and M1), M3, M9 and M15 Receives: Other: Diabetes Therapeutic Education conducted by nurses |
| Standard | No intervention | Medical follow-up every 6 months for 18 months (Inclusion, M6, M12, M18) :usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of glycated hemoglobin HBA1c
Difference in HBA1c between baseline and 12 months (M12)
Measured: 12 months
Secondary outcomes (4)
Evaluation of glycemic control over 18 months
Evaluation via Freestyle free blood glucose sensor with free view software every 6 months, over the last month and the last 3 months prior to medical consultation:
- % of time spent in target range (0.7 g/l ≤ blood glucose ≤ 1.8g/l)
- % of time spent in hypoglycemia (blood glucose <0.7 g/l,
- % of time spent in hyperglycemia (blood glucose > 1.8g/l) Recording of ketoacidosis episodes during patient attendance Recording of episodes of severe hypoglycemia requiring third-party assistance with the patient HBA1c monitoring every 3 months
Measured: 18 months
Evaluation of patients' quality of life over 18 months
Questionnaire assessing quality of life (Audit of Diabetes Dependent Quality of Life - 19 items: ADDQoL 19)
Measured: 18 months
Evaluation of patients' satisfaction with diabetes treatment
Questionnaire assessing satisfaction with diabetes treatment (Diabetes Treatment Satisfaction Questionnaires: DTSQs)
Measured: 18 months
Evaluation of long-term complications over 18 months
Assessment of the development and evolution of diabetes-related complications: neuropathy, nephropathy, retinopathy, arteriopathy, erectile dysfunction, heart disease, hypertension, foot ulcers, amputations and cerebrovascular damage.
Number of additional hospitalizations and urgent consultations for acute or chronic complications.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start9 Feb 2024
- Primary completion11 Oct 2024
- Study completion1 Mar 2025
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena BOUCHEZ, Principal investigator, Hopital Nord Franche-Comte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167499
- Sponsor's protocol ID
- 2021-05-DIABETE COACH
- Acronym
- DIABETE COACH
- Status last verified
- Aug 2025
- First submitted
- 24 Nov 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapeutic Education Consultations Conducted by Specialized Nurses on Glycemic Control and Quality of Life in Diabetic Patients Treated With Intensified Insulin Therapy: a Randomized Study
- ClinicalTrials.gov ID
- NCT06167499
- Acronym / sponsor ID
- DIABETE COACH / 2021-05-DIABETE COACH
- Conditions
- Diabete Mellitus, Insulin Dependent Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 12 Dec 2023 (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.
Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose.
All these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses.
The aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. The objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education Group. | Experimental | Other: Diabetes Therapeutic Education conducted by nursesMedical follow-up every 6 months for 18 months (inclusion, M6, M12, M18) associated with therapeutic education consultations conducted by nurses in the month following inclusion (between D0 and M1), M3, M9 and M15 |
| Standard | No intervention | –Medical follow-up every 6 months for 18 months (Inclusion, M6, M12, M18) :usual practice |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman or man aged 18 to 75
- Diabetic patient type 1 or 2 insulin-dependent
- Patient treated with multi-injections or insulin pump
- Patient equipped with FreeStyle Libre flash glucose monitoring system
- Glycemic imbalance with HBA1c > 8
Key exclusion criteria (5 listed)
- Recent discovery (< 6 months) of diabetes
- Major intellectual disability
- Social isolation
- IMC > 35
- Pregnant women
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 |
|---|---|---|
| Diabetes Therapeutic Education conducted by nursesIndividual consultations with the therapeutic education IDE, who will help the patient to achieve the therapeutic objectives set before the medical consultation. Once the objectives have been set, the IDE will set up individual workshops and subsequently assess the patient's learning and its impact on his or her care. These workshops can include equipment demonstrations and practical exercises, explanations of treatment adaptation protocols, and dietary or sexual advice. | Other | Therapeutic Education Group. |
Primary outcome
Rate of glycated hemoglobin HBA1c
Time frame: 12 months
Difference in HBA1c between baseline and 12 months (M12)
4 secondary outcomes
Evaluation of glycemic control over 18 months
Time frame: 18 months
Evaluation of patients' quality of life over 18 months
Time frame: 18 months
Evaluation of patients' satisfaction with diabetes treatment
Time frame: 18 months
Evaluation of long-term complications over 18 months
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- 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.
Elena BOUCHEZ principal investigator
Hopital Nord Franche-Comte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Therapeutic Education conducted by nurses in people with Diabete Mellitus and Insulin Dependent Diabetes, run by Hopital Nord Franche-Comte 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Aug 2025. 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 was stopped early (reason given: Futility). Results are not available in the source record.
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?
Rate of glycated hemoglobin HBA1c (time frame: 12 months). 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 8 Aug 2025.