Diabetes Mellitus, Type 1INSUDIETCOOPNCT07846852
Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
This retrospective multicenter cohort study aims to evaluate the effectiveness of an interprofessional cooperative protocol allowing dietitians to adjust prandial insulin-to-carbohydrate ratios in adults living with type 1 diabetes receiving functional insulin therapy. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Routine care data collection
- How many people
- 163 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-69 years with type 1 diabetes or insulin-deficient diabetes receiving routine care under an interprofessional cooperation protocol for prandial insulin dose adjustment. Eligible participants must have had diabetes for more than 6 months, be treated with multiple daily insulin injections or an insulin pump, and have completed structured education in functional insulin therapy. Patients with unstable proliferative retinopathy, pregnancy, other types of diabetes, temporary treatments affecting insulin requirements, legal protection measures, or who object to the use of their data are excluded
Who may be able to join
- Male or female, aged 18 to 69 years.
- Receiving routine clinical care under an interprofessional cooperation protocol for prandial insulin dose adjustment (protocol implemented since January 1, 2023).
- Living with type 1 diabetes mellitus or insulin-deficient diabetes, confirmed by the presence of anti-GAD, anti-IA2, anti-ZnT8, or insulin autoantibodies, and requiring optimization of insulin therapy.
- Diabetes duration greater than 6 months.
- Treated with multiple daily insulin injections or an insulin pump (open-loop or hybrid closed-loop system).
- Completion of a structured therapeutic education program in functional insulin therapy (individual consultations and/or educational workshops).
- Able to understand study information and procedures.
Who cannot join
- Unstable severe proliferative diabetic retinopathy.
- Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes.
- Pregnant women with type 1 diabetes.
- Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy).
- Individuals under legal guardianship, curatorship, or any other legal protection measure.
- Objection to the use of personal data for research purposes
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Service de diabétologie, Hôpital Lariboisière - AP-HP
Paris
Hélène Louvet, +33149959014, hélène.louvet@aphp.fr
Hélène Louvet
Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
Paris
Virginie Lafaille, +33156095161, virginie.lafaille@aphp.fr
Virginie Lafaille
About this study
This retrospective multicenter cohort study aims to evaluate the effectiveness of an interprofessional cooperative protocol allowing dietitians to adjust prandial insulin-to-carbohydrate ratios in adults living with type 1 diabetes receiving functional insulin therapy. Glycemic outcomes will be assessed using continuous glucose monitoring data collected during routine clinical care. The primary endpoint is the change in Time in Range (TIR) between baseline and 6 months.
Read the detailed description
Type 1 diabetes requires continuous adjustment of insulin doses according to carbohydrate intake. In France, an interprofessional cooperation protocol implemented in 2023 authorizes trained dietitians to adjust insulin-to-carbohydrate ratios under physician supervision.
This retrospective multicenter cohort study will evaluate whether this organization improves glycemic control in routine clinical practice. Data will be collected from medical records and glucose monitoring platforms without modifying patient management.
The primary outcome is the difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6). Secondary outcomes include differences in hypoglycemia, hyperglycemia, glucose variability and Glucose Management Indicator (GMI) assessed between baseline and follow-up visits at Month 3 and Month 6.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Routine care data collection
- Keywords
- Interprofessional cooperative protocol, Prandial insulin, Type 1 diabetes, Dietitian
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine care data collectionOther
Data collection from patients receiving standard care under a cooperation protocol for prandial insulin dose adjustment, with data collected from patients' medical records and glucose monitoring platforms without modifying patient management
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving routine care under a cooperation protocol for prandial insulin adjustment | Not described Receives: Other: Routine care data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
Measured: Baseline and 6 months
Secondary outcomes (7)
Difference in time spent in the glycemic target range (Time in Range, TIR between 0.70 g/L and 1.80 g/L) between M3 and M0
Measured: Baseline and 3 months
Difference in time spent in hypoglycemia (Time Below Range, TBR < 0.70 g/L) between M3 and M0 and between M6 and M0
Measured: Baseline, 3 months and 6 months
Difference in time spent in severe hypoglycemia (Time Below Range, TBR < 0.54 g/L) between M3 and M0 and between M6 and M0
Measured: Baseline, 3 months and 6 months
Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0
Measured: Baseline, 3 months and 6 months
Difference in time spent in severe hyperglycemia (Time Above Range, TAR > 2.50 g/L) between M3 and M0 and between M6 and M0
Measured: Baseline, 3 months and 6 months
Difference in glucose variability coefficient between M3 and M0 and between M6 and M0
Measured: Baseline, 3 months and 6 months
Difference in Glucose Management Indicator (GMI) between M3 and M0 and between M6 and M0
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI IDF
- Responsible party
- Sponsor
- Investigators
- Virginie Lafaille, Principal investigator, Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846852
- Sponsor's protocol ID
- APHP260780
- Acronym
- INSUDIETCOOP
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Intervention Within an Interprofessional Cooperative Protocol for Prandial Insulin Dose Adjustment in People Living With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07846852
- Acronym / sponsor ID
- INSUDIETCOOP / APHP260780
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Interprofessional cooperative protocol, Prandial insulin, Type 1 diabetes, Dietitian
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- GIRCI IDF
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 Sep 2026 (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.
This retrospective multicenter cohort study aims to evaluate the effectiveness of an interprofessional cooperative protocol allowing dietitians to adjust prandial insulin-to-carbohydrate ratios in adults living with type 1 diabetes receiving functional insulin therapy. Glycemic outcomes will be assessed using continuous glucose monitoring data collected during routine clinical care. The primary endpoint is the change in Time in Range (TIR) between baseline and 6 months.
Detailed description
Type 1 diabetes requires continuous adjustment of insulin doses according to carbohydrate intake. In France, an interprofessional cooperation protocol implemented in 2023 authorizes trained dietitians to adjust insulin-to-carbohydrate ratios under physician supervision.
This retrospective multicenter cohort study will evaluate whether this organization improves glycemic control in routine clinical practice. Data will be collected from medical records and glucose monitoring platforms without modifying patient management.
The primary outcome is the difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6). Secondary outcomes include differences in hypoglycemia, hyperglycemia, glucose variability and Glucose Management Indicator (GMI) assessed between baseline and follow-up visits at Month 3 and Month 6.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving routine care under a cooperation protocol for prandial insulin adjustment | – | Other: Routine care data collection |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-69 years with type 1 diabetes or insulin-deficient diabetes receiving routine care under an interprofessional cooperation protocol for prandial insulin dose adjustment. Eligible participants must have had diabetes for more than 6 months, be treated with multiple daily insulin injections or an insulin pump, and have completed structured education in functional insulin therapy. Patients with unstable proliferative retinopathy, pregnancy, other types of diabetes, temporary treatments affecting insulin requirements, legal protection measures, or who object to the use of their data are excluded
Key inclusion criteria (7 listed)
- Male or female, aged 18 to 69 years.
- Receiving routine clinical care under an interprofessional cooperation protocol for prandial insulin dose adjustment (protocol implemented since January 1, 2023).
- Living with type 1 diabetes mellitus or insulin-deficient diabetes, confirmed by the presence of anti-GAD, anti-IA2, anti-ZnT8, or insulin autoantibodies, and requiring optimization of insulin therapy.
- Diabetes duration greater than 6 months.
- Treated with multiple daily insulin injections or an insulin pump (open-loop or hybrid closed-loop system).
Key exclusion criteria (6 listed)
- Unstable severe proliferative diabetic retinopathy.
- Any type of diabetes other than type 1 diabetes or insulin-deficient diabetes.
- Pregnant women with type 1 diabetes.
- Current treatment with temporary therapies that may affect insulin requirements (e.g., chemotherapy or systemic corticosteroid therapy).
- Individuals under legal guardianship, curatorship, or any other legal protection measure.
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 |
|---|---|---|
| Routine care data collectionData collection from patients receiving standard care under a cooperation protocol for prandial insulin dose adjustment, with data collected from patients' medical records and glucose monitoring platforms without modifying patient management | Other | Patients receiving routine care under a cooperation protocol for prandial insulin adjustment |
Primary outcome
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6)
Time frame: Baseline and 6 months
7 secondary outcomes
Difference in time spent in the glycemic target range (Time in Range, TIR between 0.70 g/L and 1.80 g/L) between M3 and M0
Time frame: Baseline and 3 months
Difference in time spent in hypoglycemia (Time Below Range, TBR < 0.70 g/L) between M3 and M0 and between M6 and M0
Time frame: Baseline, 3 months and 6 months
Difference in time spent in severe hypoglycemia (Time Below Range, TBR < 0.54 g/L) between M3 and M0 and between M6 and M0
Time frame: Baseline, 3 months and 6 months
Difference in time spent in hyperglycemia (Time Above Range, TAR > 1.80 g/L) between M3 and M0 and between M6 and M0
Time frame: Baseline, 3 months and 6 months
Difference in time spent in severe hyperglycemia (Time Above Range, TAR > 2.50 g/L) between M3 and M0 and between M6 and M0
Time frame: Baseline, 3 months and 6 months
Difference in glucose variability coefficient between M3 and M0 and between M6 and M0
Time frame: Baseline, 3 months and 6 months
Difference in Glucose Management Indicator (GMI) between M3 and M0 and between M6 and M0
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Virginie Lafaille principal investigator
Service de nutrition - diabétologie, Hôpital Européen Georges Pompidou - AP-HP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 7 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youcef Sekour (+33156095823, youcef.sekour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Time in Range (0.70-1.80 g/L) between baseline (M0) and Month 6 (M6) (time frame: Baseline and 6 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 29 Sep 2026.