Diabetes Mellitus, Type 1PRO-DIAB-1NCT06050642
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
A study testing enhanced care model provided by Timkl, a home support provider in people with Diabetes Mellitus, Type 1, run by timkl at 1 site in France.
Trial summary
Amidst medical innovations, many Type 1 diabetes patients using advanced therapy show improved control but still suffer from diabetes-related distress. To tackle this, the investigators propose an "enhanced care" model involving healthcare providers and pharmacists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- enhanced care model provided by Timkl, a home support provider
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2023to Oct 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be an adult (age ≥ 18 years)
- Have Type 1 diabetes
- Have been on closed-loop or insulin pump therapy for ≥ 6 months
- Be in moderate or high diabetes-related distress defined as a DDS2 score ≥ 6
- Be able to understand and complete questionnaires in French
- Be affiliated to the general French Social Security system
Show all 14Show fewer
- Have an e-mail address
- Have a cell phone number
- Non-inclusion criteria:
- Be deprived of liberty, under guardianship or curatorship
- Not have Internet access or a cell phone
- Have benefited or are already benefiting from the Enhanced Care program
- Participating in an interventional study on a medical device for diabetes (pump, sensors, etc.)
- Patients who are not regularly monitored in the investigating center proposing to include them, or who are likely to change centers or move to a different living area (pharmacy) within a year of inclusion.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nice - Hôpital l'Archet 2
Nice, Paca
Nicolas CHEVALIER, chevalier.n@chu-nice.fr
Nicolas CHEVALIER, MD
About this study
Official title: PRO-DIAB-1: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
Amidst medical innovations, many Type 1 diabetes patients using advanced therapy show improved control but still suffer from diabetes-related distress. To tackle this, the investigators propose an "enhanced care" model involving healthcare providers and pharmacists. The study compares standard and enhanced care for Type 1 adults, focusing on the pharmacist's role.
The main question it aims to answer is : In patients with type 1 diabetes treated with pump or closed-loop therapy, does the improved enhanced care versus conventional layout improve diabetes-related distress at 12 months?
Participants will complete a monthly online questionnaire to assess their diabetes-related distress as well as their frequency of use of standard and enhanced care as well as the associated patient satisfaction.
Read the detailed description
Amidst accelerating innovations in care and limited medical time, many patients with Type 1 diabetes treated by pump or closed-loop therapy appear to have improved glycaemic control, but still experience significant diabetes-related distress.
The investigators therefore propose that a new form of patient care service provided by a health service provider and the patient's pharmacist, as part of the new type of care called "enhanced care", could contribute to overcoming this challenge.
This study compares two different care services provided to adult patients with Type 1 diabetes (PwT1D) treated with an insulin pump or a closed-loop system, known as standard care and enhanced care, the main difference between which lies in the pharmacist's involvement in the enhanced care model.
The originality of this project lies in several points:
- Firstly, it involves evaluating a new care model called enhanced care, which has the original feature of including the involvement of the patient's dispensing pharmacist.
- The role of home support providers in the psychological aspects of diabetes is poorly documented in the scientific literature.
Diabetes-related distress is a well-known complication, but means of prevention remain inadequate. This study integrates live collection of patient data, by the patient. Patient experience is an innovative approach that plays an increasingly important role in the evaluation of new management approaches.
- In addition to patient data, this study integrates data from pharmacists and physicians. These data will be used to compare the points of view of healthcare professionals and patients, in order to gain a precise idea of the service provided by the enhanced care. In itself, this comparison could contribute to identifying and understanding the difference in the points of view of healthcare professionals and patients.
- While there is a wealth of literature demonstrating the value of pharmacist involvement in the care of Type 2 diabetic patients, such information is lacking for Type 1 diabetes. This study, aimed at investigating the impact of the pharmacist, specifically on the distress of patients undergoing highly technical treatment, is therefore original.
- Finally, the design of this pragmatic, randomized study enables real-life practices to be analyzed, while maintaining the highest possible level of evidence.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- enhanced care model provided by Timkl, a home support provider
- Keywords
- type 1 diabetes, diabetes distress, insulin pump, insuline closed-loop, home support provider, quality of life, disease burden, treatment satisfaction, Time in Range, Patient-Physician interactions, Pharmacist
- 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.
enhanced care model provided by Timkl, a home support providerOther
A new type of care provided by timkl, a home support provider, involving nurses and the dispensing pharmacist. This approach combines the current tasks of the service provider's nurses with closer monitoring by the pharmacist, thanks to more frequent contacts and a holistic view of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Control arm (Standard Care) | No intervention | these patients will continue with their current home support provider's standard care |
| Interventional arm (Enhanced Care) | Experimental | these patients will be prescribed the enhanced care model to replace the standard care provided by their current home support provider. Patients are informed that they can return to standard care at the end of the study period (1 year), or at any time if they wish to leave the study. Receives: Other: enhanced care model provided by Timkl, a home support provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Compare patient-reported levels of diabetes-related distress at 12 months. Higher T1-DDS-7 scores indicate higher levels of diabetes-related distress.
Measured: Baseline visit (Month 0) to Final visit (Month 12)
Secondary outcomes (28)
A.1 Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Compare patient-reported levels of diabetes-related distress at 6 months. Higher T1-DDS-7 scores indicate higher levels of diabetes-related distress.
Measured: Baseline (Month 0) to Month 6
A.2 Change in the sub-scores of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Compare the dimensions of patient-reported levels of diabetes-related distress individually at 12 months.
Each question of the T1-DDS-7 reports a different dimension of diabetes-related distress.
Higher sub-scores indicate higher levels of diabetes-related distress in their respective dimensions.
Measured: Baseline (Month 0) to Month 12
A.3a Evolution of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Time-series analysis of the evolution of T1-DDS-7 scores over the course of the 12-month observation period. T1-DDS-7 is assessed quarterly. Higher T1-DDS-7 scores indicate higher levels of diabetes-related distress.
Measured: quarterly between Baseline (Month 0) and Month 12
A.3b Evolution of the 2-question Diabetes Distress Score (DDS2) [Comparison: Enhanced Care vs Standard Care]
Time-series analysis of the evolution of DDS2 scores over the course of the 12-month observation period. Higher scores indicate higher levels of diabetes-related distress. DDS2 is every month during which the T1-DDS-7 is not.
This time series will be used to complete the time-series of T1-DDS-7 scores.
Measured: 8 times between Baseline (Month 0) and Month 12
B.1a Patient overall satisfaction with services provided by the home support provider
Overall satisfaction is assessed using a Visual Analog Score ranging from 0 to 10, with higher values indicating higher satisfaction.
Measured: monthly between Baseline (Month 0) and Month 12
B.1b Frequency of patients' interactions with the home support provider
Number of contacts with a representative of the home support provider during the previous month.
Representatives include : nurses, psychologists, and pharmacists (intervention group only).
Measured: monthly between Baseline (Month 0) and Month 12
B.1c Satisfaction with specific aspects of the services provided by the home support provider
The following aspects of services provided were each assessed using a 5-point Likert scale, ranging from "completely satisfied" to "completely dissatisfied":
- Were the interactions appropriately personalized for the patient?
- Were the interactions of adequate quality?
- Did the patient feel they could trust the representative?
- Were the interactions of an appropriate length?
- Was the location of the interactions satisfactory?
- Was the organization of the interactions satisfactory?
- Was the number of the interactions satisfactory? The above Likert values may be averaged to provide an overall satisfaction score.
Measured: monthly between Baseline (Month 0) and Month 12
B.2a (Intervention group only) Number of pharmacy visits
To describe the actual intervention during the study, each visit will be reported in the online SanoWeb system.
The number of pharmacy visits per patient will be counted using SanoWeb data.
Measured: monthly between Baseline (Month 0) and Month 12
B.2b (Intervention group only) Duration of pharmacy visits
The duration of pharmacy visits will be evaluated using SanoWeb data.
Measured: monthly between Baseline (Month 0) and Month 12
B.2c (Intervention group only) Description of clinical or non-clinical events impacting diabetes
During pharmacy visits, patients will have the opportunity to report clinical and non-clinical events. These events are recorded in the SanoWeb system.
Measured: monthly between Baseline (Month 0) and Month 12
B.3a Patients' Perceived Effectiveness of Patient-Physician Interactions (PEPPI questionnaire)
The PEPPI questionnaire will be used to assess patients' perceived effectiveness of their interactions with their diabetes specialist. Higher scores indicate better perceived efficacy.
Measured: at Month 6 and at Month 12
B.3b Patient Assessment of Chronic Illness Care (PACIC questionnaire)
The PACIC questionnaire will be used to obtain patients' assessment of overall management. Higher scores indicate a better assessment of care.
Measured: at Baseline (Month 0) and at Month 12
B.3c Patient assessment of information flow and transparency
5-point Likert scale, ranging from "completely satisfied" to "completely dissatisfied"
Measured: at Month 6 and at Month 12
B.3d Patient assessment of how representatives of the home support provider treat confidential information
5-point Likert scale, ranging from "completely satisfied" to "completely dissatisfied"
Measured: at Month 6 and at Month 12
B.4a Specialist Physician satisfaction with the services provided by the home support provider to their patients
Overall satisfaction is assessed using a Visual Analog Score ranging from 0 to 10, with higher values indicating higher satisfaction.
Measured: Month 12
B.4b Specialist Physician satisfaction with quantity and pertinence information provided by the home support provider on their patients
Satisfaction is assessed using a Visual Analog Score ranging from 0 to 10, with higher values indicating higher satisfaction.
Measured: Month 12
B.5a (intervention group) Pharmacist satisfaction with the services provided by the home support provider to their patients
Overall satisfaction is assessed using a Visual Analog Score ranging from 0 to 10, with higher values indicating higher satisfaction.
Measured: Month 12
B.5b (intervention group) Pharmacist satisfaction with the length of interactions with patients
Satisfaction is assessed using a Visual Analog Score ranging from 0 to 10, with higher values indicating higher satisfaction.
Measured: Month 12
B.5c (intervention group) Pharmacist satisfaction with the number of interactions with patients
Satisfaction is assessed using a Visual Analog Score ranging from 0 to 10, with higher values indicating higher satisfaction.
Measured: Month 12
B.5d (intervention group) Pharmacist perception of the usefulness of their increased role in diabetes management
Visual Analog Score ranging from 0 to 10, with higher values indicating higher levels of perceived usefulness.
Measured: Month 12
C.1 Self-reported ability to use their insulin delivery system(pump or closed loop) [Comparison: Enhanced Care vs Standard Care]
3 Visual Analog Scores ranging from 0 to 10s on pump or closed loop use :
- device management
- use of basic device functions
- use of advanced device functions Higher scores indicate better ability to use the device.
Measured: monthly from Baseline (Month 0) to Month 12
Physician assessment of patient's ability to use their insulin delivery system (pump or closed loop [Comparison: Enhanced Care vs Standard Care]
3 Visual Analog Scores on physician's assessment of the patient's ability to use their insulin delivery system:
- device management
- use of basic device functions
- use of advanced device functions Higher scores indicate better perceived ability to use the device.
Measured: Month 12
C.3a Patient satisfaction with treatment as measured by the Diabetes Treatment Satisfaction Questionnaire - status (DTSQs) [Comparison: Enhanced Care vs Standard Care]
The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) is an 8-question tool widely used in routine practice. Higher scores indicate higher satisfaction with their treatment.
Measured: Baseline (Month 0) and at Month 12
C.3b Patient perception of treatment burden [Comparison: Enhanced Care vs Standard Care]
The Timkl-1 questionnaire is a 9-question tool used to assess patients' treatment burden, need for an enhanced care service, and quality of life.
This outcome uses the treatment burden subscore, for which higher scores indicate a greater burden.
Measured: Baseline (Month 0) and at Month 12
D.1 Time in the glycemic target range [Comparison: Enhanced Care vs Standard Care]
Time in the glycemic target range (Time-in-range or TIR) is an intuitive metric that denotes the amount of time in percentage that a person's glucose level remains within the proposed target range.
Using measurements from continuous or flash glucose monitoring systems, TIR is the percentage of data points between 70 and 180 mg/dL.
Complementary metrics are used:
- Time below range (TBR) = percentage of data points < 54 mg/dL
- Time above range (TAR) = percentage of data points > 180 mg/dL
Measured: Month 12
Percentage of glycated hemoglobin (HbA1c) [Comparison: Enhanced Care vs Standard Care]
The HbA1c test is used to evaluate a person's level of glucose control. The test shows an average of the blood sugar level over the past 90 days and represents a percentage. Higher values tend to indicate worse levels of glucose control.
Measured: at Baseline (Month 0) and at Month 12
E.1 Patient quality of life [Comparison: Enhanced Care vs Standard Care]
The Timkl-1 questionnaire is a 9-question tool used to assess patients' treatment burden, need for an enhanced care service, and quality of life.
This outcome uses the quality of life subscore, for which higher scores indicate a better quality of life.
Measured: at Baseline (Month 0) and at Month 12
E.2 Number and relevance of impact that can have an impact on diabetes [Comparison: Enhanced Care vs Standard Care]
- (intervention group) Number and relevance of clinical or non-clinical events reported by the patient to the pharmacist
- Number and relevance of clinical or non-clinical events reported by patients to their specialist doctor
- Number and relevance of clinical or non-clinical events reported by the patient (ePRO)
Measured: monthly between Baseline (Month 0) and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start4 Sep 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (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.
- 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
- Model description
- pragmatic, randomized, prospective, multisite (national), real-life study comparing home support service models
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- timkl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanoia
- Responsible party
- Sponsor
- Investigators
- Bruno GUERCI, MD PhD, Principal investigator, Central Hospital, Nancy, FranceGérard REACH, MD PhD, Study chair, Université Sorbonne Paris Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050642
- Sponsor's protocol ID
- PRO-DIAB-1
- Other IDs
- 2023-A00891-44
- Acronym
- PRO-DIAB-1
- Status last verified
- Jul 2025
- First submitted
- 1 Sep 2023
- Last updated
- 18 Jul 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO-DIAB-1: Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
- ClinicalTrials.gov ID
- NCT06050642
- Acronym / sponsor ID
- PRO-DIAB-1 / PRO-DIAB-1
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1 diabetes, diabetes distress, insulin pump, insuline closed-loop, home support provider, quality of life, disease burden, treatment satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- timklIndustry (pharma, biotech, devices)
- Collaborators
- Sanoia
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 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.
Amidst medical innovations, many Type 1 diabetes patients using advanced therapy show improved control but still suffer from diabetes-related distress. To tackle this, the investigators propose an "enhanced care" model involving healthcare providers and pharmacists. The study compares standard and enhanced care for Type 1 adults, focusing on the pharmacist's role.
The main question it aims to answer is : In patients with type 1 diabetes treated with pump or closed-loop therapy, does the improved enhanced care versus conventional layout improve diabetes-related distress at 12 months?
Participants will complete a monthly online questionnaire to assess their diabetes-related distress as well as their frequency of use of standard and enhanced care as well as the associated patient satisfaction.
Detailed description
Amidst accelerating innovations in care and limited medical time, many patients with Type 1 diabetes treated by pump or closed-loop therapy appear to have improved glycaemic control, but still experience significant diabetes-related distress.
The investigators therefore propose that a new form of patient care service provided by a health service provider and the patient's pharmacist, as part of the new type of care called "enhanced care", could contribute to overcoming this challenge.
This study compares two different care services provided to adult patients with Type 1 diabetes (PwT1D) treated with an insulin pump or a closed-loop system, known as standard care and enhanced care, the main difference between which lies in the pharmacist's involvement in the enhanced care model.
The originality of this project lies in several points:
- Firstly, it involves evaluating a new care model called enhanced care, which has the original feature of including the involvement of the patient's dispensing pharmacist.
- The role of home support providers in the psychological aspects of diabetes is poorly documented in the scientific literature.
Diabetes-related distress is a well-known complication, but means of prevention remain inadequate. This study integrates live collection of patient data, by the patient. Patient experience is an innovative approach that plays an increasingly important role in the evaluation of new management approaches.
- In addition to patient data, this study integrates data from pharmacists and physicians. These data will be used to compare the points of view of healthcare professionals and patients, in order to gain a precise idea of the service provided by the enhanced care. In itself, this comparison could contribute to identifying and understanding the difference in the points of view of healthcare professionals and patients.
- While there is a wealth of literature demonstrating the value of pharmacist involvement in the care of Type 2 diabetic patients, such information is lacking for Type 1 diabetes. This study, aimed at investigating the impact of the pharmacist, specifically on the distress of patients undergoing highly technical treatment, is therefore original.
- Finally, the design of this pragmatic, randomized study enables real-life practices to be analyzed, while maintaining the highest possible level of evidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pragmatic, randomized, prospective, multisite (national), real-life study comparing home support service models
| Arm | Type | Receives |
|---|---|---|
| Control arm (Standard Care) | No intervention | –these patients will continue with their current home support provider's standard care |
| Interventional arm (Enhanced Care) | Experimental | Other: enhanced care model provided by Timkl, a home support providerthese patients will be prescribed the enhanced care model to replace the standard care provided by their current home support provider. Patients are informed that they can return to standard care at the end of the study period (1 year), or at any time if they wish to leave the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Be an adult (age ≥ 18 years)
- Have Type 1 diabetes
- Have been on closed-loop or insulin pump therapy for ≥ 6 months
- Be in moderate or high diabetes-related distress defined as a DDS2 score ≥ 6
- Be able to understand and complete questionnaires in French
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| enhanced care model provided by Timkl, a home support providerA new type of care provided by timkl, a home support provider, involving nurses and the dispensing pharmacist. This approach combines the current tasks of the service provider's nurses with closer monitoring by the pharmacist, thanks to more frequent contacts and a holistic view of the patient. | Other | Interventional arm (Enhanced Care) |
Primary outcome
Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Time frame: Baseline visit (Month 0) to Final visit (Month 12)
Compare patient-reported levels of diabetes-related distress at 12 months. Higher T1-DDS-7 scores indicate higher levels of diabetes-related distress.
28 secondary outcomes
A.1 Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Time frame: Baseline (Month 0) to Month 6
A.2 Change in the sub-scores of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Time frame: Baseline (Month 0) to Month 12
A.3a Evolution of the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care]
Time frame: quarterly between Baseline (Month 0) and Month 12
A.3b Evolution of the 2-question Diabetes Distress Score (DDS2) [Comparison: Enhanced Care vs Standard Care]
Time frame: 8 times between Baseline (Month 0) and Month 12
B.1a Patient overall satisfaction with services provided by the home support provider
Time frame: monthly between Baseline (Month 0) and Month 12
B.1b Frequency of patients' interactions with the home support provider
Time frame: monthly between Baseline (Month 0) and Month 12
B.1c Satisfaction with specific aspects of the services provided by the home support provider
Time frame: monthly between Baseline (Month 0) and Month 12
B.2a (Intervention group only) Number of pharmacy visits
Time frame: monthly between Baseline (Month 0) and Month 12
B.2b (Intervention group only) Duration of pharmacy visits
Time frame: monthly between Baseline (Month 0) and Month 12
B.2c (Intervention group only) Description of clinical or non-clinical events impacting diabetes
Time frame: monthly between Baseline (Month 0) and Month 12
B.3a Patients' Perceived Effectiveness of Patient-Physician Interactions (PEPPI questionnaire)
Time frame: at Month 6 and at Month 12
B.3b Patient Assessment of Chronic Illness Care (PACIC questionnaire)
Time frame: at Baseline (Month 0) and at Month 12
B.3c Patient assessment of information flow and transparency
Time frame: at Month 6 and at Month 12
B.3d Patient assessment of how representatives of the home support provider treat confidential information
Time frame: at Month 6 and at Month 12
B.4a Specialist Physician satisfaction with the services provided by the home support provider to their patients
Time frame: Month 12
B.4b Specialist Physician satisfaction with quantity and pertinence information provided by the home support provider on their patients
Time frame: Month 12
B.5a (intervention group) Pharmacist satisfaction with the services provided by the home support provider to their patients
Time frame: Month 12
B.5b (intervention group) Pharmacist satisfaction with the length of interactions with patients
Time frame: Month 12
B.5c (intervention group) Pharmacist satisfaction with the number of interactions with patients
Time frame: Month 12
B.5d (intervention group) Pharmacist perception of the usefulness of their increased role in diabetes management
Time frame: Month 12
C.1 Self-reported ability to use their insulin delivery system(pump or closed loop) [Comparison: Enhanced Care vs Standard Care]
Time frame: monthly from Baseline (Month 0) to Month 12
Physician assessment of patient's ability to use their insulin delivery system (pump or closed loop [Comparison: Enhanced Care vs Standard Care]
Time frame: Month 12
C.3a Patient satisfaction with treatment as measured by the Diabetes Treatment Satisfaction Questionnaire - status (DTSQs) [Comparison: Enhanced Care vs Standard Care]
Time frame: Baseline (Month 0) and at Month 12
C.3b Patient perception of treatment burden [Comparison: Enhanced Care vs Standard Care]
Time frame: Baseline (Month 0) and at Month 12
D.1 Time in the glycemic target range [Comparison: Enhanced Care vs Standard Care]
Time frame: Month 12
Percentage of glycated hemoglobin (HbA1c) [Comparison: Enhanced Care vs Standard Care]
Time frame: at Baseline (Month 0) and at Month 12
E.1 Patient quality of life [Comparison: Enhanced Care vs Standard Care]
Time frame: at Baseline (Month 0) and at Month 12
E.2 Number and relevance of impact that can have an impact on diabetes [Comparison: Enhanced Care vs Standard Care]
Time frame: monthly between Baseline (Month 0) and Month 12
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 18 Jul 2025.
- study portalLink provided by the sponsor.
- 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.
Bruno GUERCI, MD PhD principal investigator
Central Hospital, Nancy, France
Gérard REACH, MD PhD study chair
Université Sorbonne Paris Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced care model provided by Timkl, a home support provider in people with Diabetes Mellitus, Type 1, run by timkl 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 14 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Jul 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?
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 Antoine POUYET, MM (+33 4 76 52 67 49, antoine.pouyet@timkl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 7-question Type-1 Diabetes Distress Score (T1-DDS-7) [Comparison: Enhanced Care vs Standard Care] (time frame: Baseline visit (Month 0) to Final visit (Month 12)). 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 18 Jul 2025.