Cystic Fibrosis-related DiabetesPhase 4MIRENCT04381429
Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes
A Phase 4 study testing A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP) and F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid) in people with Cystic Fibrosis-related Diabetes, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages. Insulin deficiency has serious clinical consequences by increasing malnutrition, since protein and lipid catabolism is accelerated in chronic infections. Traditionally, insulin is injected before a meal. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis-related Diabetes
- What is being tested?
- A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP) and F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2020to 20 Jan 2025
- Phase
- Phase 4
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with cystic fibrosis related diabetes aged over 10 years (no upper age limite)
- Patient treated by multiple insulin injections (minimal three insulin injections per day or basal bolus insulin regimen) or insulin pump
- Patient with CGM from over 3 months (at the signature of the study's informed consent) or patient not wearing a CGM device, but agreeing a CGM at the inclusion and at the end of each treatment period of 3 months
- Naive patient of Fiasp or patient under Fiasp, having carried out a run-in period of one month with rapid acting insulin treatment
- Affiliated to a social security scheme
- Subject able to understand the objectives and the risks related to the research and to give a dated and signed informed consent
- Subject having been informed of the results of the prior medical examination
- Written informed consent, dated and signed before initiating any trial-related procedure (if the subject is a minor, the consent must be signed by the 2 legal representative and the patient if he/she is able to give consent)
Who cannot join
- Patient with type 1 or type 2 diabetes
- Patient with cystic fibrosis related diabetes treated with 2 injections / day
- Patient with an HbA1C greater than 12% who demonstrate therapeutic non-compliance
- Patient pregnant (positive urinary pregnancy test) or wishing to pregnancy
- Contraindication to Aspart insulin
- Patient on lung transplant waiting list or transplanted within one year prior to the inclusion visit
Show all 12Show fewer
- Patient who started treatment with Trikafta® within 3 months prior to the inclusion visit
- Patient who cannot be followed during 12 months
- Subject in exclusion period (determined by previous or current clinical study)
- Impossibility of giving the subject enlightened information (subject in emergency situation, difficulties of understanding, cognitive impairment...)
- Subject under the protection of justice
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial
Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages. Insulin deficiency has serious clinical consequences by increasing malnutrition, since protein and lipid catabolism is accelerated in chronic infections. Traditionally, insulin is injected before a meal. Yet, in these patients with highly varied and often staggered nutritional intakes, insulin injection can result in an increased risk of postprandial hypoglycaemia, all the more so as CF patients exhibit decreased glucagon secretion.
Recent progress in the development of new insulins mimicking the physiological secretion more closely has led to ultra-fast insulins (fast aspart), allowing for postprandial hyperglycaemia to be better controlled. In Type 1 diabetics treated with basal-bolus, faster-acting aspart insulin injected after a meal enabled metabolic control comparable to injection of aspart insulin prior to the meal. Fast apart insulin is of particular interest with regard to CFRD, wherein postprandial hyperglycaemia occurs early. In CFRD, these insulins are likewise advantageous in that they can be injected after the meal, thus permitting more flexibility in patients with highly varied diets. Moreover, the insulin dose can be adapted depending on dietary intake, thus preventing hypoglycaemia secondary to highly-varied carbohydrate intakes. Due to its flexibility, this insulin therapy is likely to be better accepted by patients with cystic fibrosis.
Read the detailed description
The investigators hypothesis that post prandial administration of Insulin faster-acting aspart insulin in patients with CFRD may contribute to a better metabolic control with a decrease of hypoglycaemia and facilitate insulin administration according to the real food intake. The use of Insulin faster-acting aspart insulin will facilitate the functional insulin therapy. More particularly for CF patients, optimization of metabolic control should contribute to maintain a good nutritional status and to slowing the decline of respiratory function and improve the quality of life.
Patients with cystic fibrosis related diabetes and treated by multiple insulin injection (minimal three insulin injection per day or basal bolus insulin regimen) or insulin pump with CGM from over 3 months were included in an open, randomized, two-treatments - 4 periods of 3 months - 2 groups cross-over superiority study. Each group of patients will test both insulin treatments (A = pre prandial Aspart insulin, F = post prandial Faster-acting aspart insulin) in alternating periods with the following sequences: Group 1: A-F-A-F, Group 2: F-A-F-A The patients will be randomized to either one or the other sequence, which defines the groups, and take A or F in each of the 4 periods of the study. Each treatment period will last 3 months.
CGM (free style libre, Abott) will be performed for 2 weeks at baseline and after each 4 months period.
- Conditions
- Cystic Fibrosis-related Diabetes
- Being tested
- A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP), F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP)Drug
Also called All patients will have both treatments: NovoRapid + FIASP
A = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP)
F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)Drug
Also called All patients will have both treatments: NovoRapid + FIASP
A = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: A-F-A-F | Active comparator | The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study.
All patients will test both insulin treatments (A and F) in alternating periods.
The patients of group 1 will start with pre-prandial aspart insulin (NovoRapid).
Each treatment period will last 3 months. Receives: Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP) |
| Groupe 2: F-A-F-A | Active comparator | The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study.
All patients will test both insulin treatments (A and F) in alternating periods.
The patients of group 2 will start with post prandial Faster-acting aspart insulin (FIASP). Receives: Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of time in range of blood glucose variation (70-180 mg/dl) versus baseline at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months) is assessed.
Measured: This measurement is assessed at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months). Month 3, month 6, month 9 and month 12.
Secondary outcomes (14)
Other CGM parameters: mean glucose value per day (mg/dl)
Measured: screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12
Other CGM parameters: glucose area under the curve for glucose value>180mg/dl - number of glucose values<70 mg/dl-number of glucose values<53mg/dl
Measured: screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12
Other CGM parameters: time in range of blood glucose >180, >140 <70mg/dl
Measured: screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12
Hypoglycaemic events experienced by the patient - number of symptomatic hypoglycaemic events under 70 mg/dl par mois - number of major hypoglycaemic events per year - number of nocturnal hypoglycaemic events per month
Measured: Inclusion visit (Day0)-visit Month 3(3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of nutritional status: Body Mass Index (BMI)
Measured: visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of nutritional status : bioelectrical impedance - Albumin and Pre albumin
Measured: visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of nutritional status : Albumin and Pre albumin (g/l)
Measured: visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of metabolic status: HbA1c (mmol/l and %)
Measured: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of metabolic status: daily exogenous need of insulin (UI/day)
Measured: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Assessment of respiratory function parameters : FEV1, CV (L and %)
Measured: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Assessment of respiratory function parameters : O2 saturation (%)
Measured: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Assessment of respiratory function parameters : Number of cures of IV antibiotics per year (collect this information at each visit)
Measured: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Number patients with severe hypoglycaemia and serious adverse events
Measured: Inclusion visit (Day 0)-visit Month 3(3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Other CGM parameters: Time in range of blood glucose 70-140 mg/dl
Measured: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start17 Aug 2020
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Why it stopped: Difficulties of inclusion in this rare pathology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381429
- Sponsor's protocol ID
- 7546
- Acronym
- MIRE
- Status last verified
- Feb 2025
- First submitted
- 30 Apr 2020
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial
- ClinicalTrials.gov ID
- NCT04381429
- Acronym / sponsor ID
- MIRE / 7546
- Conditions
- Cystic Fibrosis-related Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties of inclusion in this rare pathology
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 8 May 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.
Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages. Insulin deficiency has serious clinical consequences by increasing malnutrition, since protein and lipid catabolism is accelerated in chronic infections. Traditionally, insulin is injected before a meal. Yet, in these patients with highly varied and often staggered nutritional intakes, insulin injection can result in an increased risk of postprandial hypoglycaemia, all the more so as CF patients exhibit decreased glucagon secretion.
Recent progress in the development of new insulins mimicking the physiological secretion more closely has led to ultra-fast insulins (fast aspart), allowing for postprandial hyperglycaemia to be better controlled. In Type 1 diabetics treated with basal-bolus, faster-acting aspart insulin injected after a meal enabled metabolic control comparable to injection of aspart insulin prior to the meal. Fast apart insulin is of particular interest with regard to CFRD, wherein postprandial hyperglycaemia occurs early. In CFRD, these insulins are likewise advantageous in that they can be injected after the meal, thus permitting more flexibility in patients with highly varied diets. Moreover, the insulin dose can be adapted depending on dietary intake, thus preventing hypoglycaemia secondary to highly-varied carbohydrate intakes. Due to its flexibility, this insulin therapy is likely to be better accepted by patients with cystic fibrosis.
Detailed description
The investigators hypothesis that post prandial administration of Insulin faster-acting aspart insulin in patients with CFRD may contribute to a better metabolic control with a decrease of hypoglycaemia and facilitate insulin administration according to the real food intake. The use of Insulin faster-acting aspart insulin will facilitate the functional insulin therapy. More particularly for CF patients, optimization of metabolic control should contribute to maintain a good nutritional status and to slowing the decline of respiratory function and improve the quality of life.
Patients with cystic fibrosis related diabetes and treated by multiple insulin injection (minimal three insulin injection per day or basal bolus insulin regimen) or insulin pump with CGM from over 3 months were included in an open, randomized, two-treatments - 4 periods of 3 months - 2 groups cross-over superiority study. Each group of patients will test both insulin treatments (A = pre prandial Aspart insulin, F = post prandial Faster-acting aspart insulin) in alternating periods with the following sequences: Group 1: A-F-A-F, Group 2: F-A-F-A The patients will be randomized to either one or the other sequence, which defines the groups, and take A or F in each of the 4 periods of the study. Each treatment period will last 3 months.
CGM (free style libre, Abott) will be performed for 2 weeks at baseline and after each 4 months period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: A-F-A-F | Active comparator | Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP)The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study. All patients will test both insulin treatments (A and F) in alternating periods. The patients of group 1 will start with pre-prandial aspart insulin (NovoRapid). Each treatment period will last 3 months. |
| Groupe 2: F-A-F-A | Active comparator | Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study. All patients will test both insulin treatments (A and F) in alternating periods. The patients of group 2 will start with post prandial Faster-acting aspart insulin (FIASP). |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with cystic fibrosis related diabetes aged over 10 years (no upper age limite)
- Patient treated by multiple insulin injections (minimal three insulin injections per day or basal bolus insulin regimen) or insulin pump
- Patient with CGM from over 3 months (at the signature of the study's informed consent) or patient not wearing a CGM device, but agreeing a CGM at the inclusion and at the end of each treatment period of 3 months
- Naive patient of Fiasp or patient under Fiasp, having carried out a run-in period of one month with rapid acting insulin treatment
- Affiliated to a social security scheme
Key exclusion criteria (12 listed)
- Patient with type 1 or type 2 diabetes
- Patient with cystic fibrosis related diabetes treated with 2 injections / day
- Patient with an HbA1C greater than 12% who demonstrate therapeutic non-compliance
- Patient pregnant (positive urinary pregnancy test) or wishing to pregnancy
- Contraindication to Aspart insulin
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 |
|---|---|---|
| A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP)Also: All patients will have both treatments: NovoRapid + FIASPA = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP) | Drug | Group 1: A-F-A-F |
| F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)Also: All patients will have both treatments: NovoRapid + FIASPA = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP) | Drug | Groupe 2: F-A-F-A |
Primary outcome
Change of time in range of blood glucose variation (70-180 mg/dl) versus baseline at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months) is assessed.
Time frame: This measurement is assessed at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months). Month 3, month 6, month 9 and month 12.
14 secondary outcomes
Other CGM parameters: mean glucose value per day (mg/dl)
Time frame: screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12
Other CGM parameters: glucose area under the curve for glucose value>180mg/dl - number of glucose values<70 mg/dl-number of glucose values<53mg/dl
Time frame: screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12
Other CGM parameters: time in range of blood glucose >180, >140 <70mg/dl
Time frame: screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12
Hypoglycaemic events experienced by the patient - number of symptomatic hypoglycaemic events under 70 mg/dl par mois - number of major hypoglycaemic events per year - number of nocturnal hypoglycaemic events per month
Time frame: Inclusion visit (Day0)-visit Month 3(3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of nutritional status: Body Mass Index (BMI)
Time frame: visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of nutritional status : bioelectrical impedance - Albumin and Pre albumin
Time frame: visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of nutritional status : Albumin and Pre albumin (g/l)
Time frame: visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of metabolic status: HbA1c (mmol/l and %)
Time frame: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Markers of metabolic status: daily exogenous need of insulin (UI/day)
Time frame: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Assessment of respiratory function parameters : FEV1, CV (L and %)
Time frame: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Assessment of respiratory function parameters : O2 saturation (%)
Time frame: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Assessment of respiratory function parameters : Number of cures of IV antibiotics per year (collect this information at each visit)
Time frame: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Number patients with severe hypoglycaemia and serious adverse events
Time frame: Inclusion visit (Day 0)-visit Month 3(3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Other CGM parameters: Time in range of blood glucose 70-140 mg/dl
Time frame: screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
Results and safety
The study was stopped early (reason given: Difficulties of inclusion in this rare pathology). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 4 study testing A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP) and F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid) in people with Cystic Fibrosis-related Diabetes, run by University Hospital, Strasbourg, France 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 8 inclusion and 12 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 5 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties of inclusion in this rare pathology). 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?
Change of time in range of blood glucose variation (70-180 mg/dl) versus baseline at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months) is assessed. (time frame: This measurement is assessed at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months). Month 3, month 6, month 9 and 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 5 Mar 2025.