Type1diabetesEVANEWFIT2NCT03311516
New Insulin Therapy by Multiwave Bolus
A study testing New functional insulin therapy and functional insulin therapy in people with Type1diabetes, run by Central Hospital, Nancy, France at 6 sites in France.
Trial summary
The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of insulin is calculated on the basis of protein and fat content in food intake, in addition to that of carbohydrates in T1D patients treated by insulin pump. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- New functional insulin therapy and functional insulin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesFrance
- Study dates
- 10 Oct 2019to Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetic patient for more than one year, practicing functional insulin for at least 3 months but not more than 5 years
- Patient treated with external insulin pump (Medtronic or Omnipod pump)
- Patient performing intermittent blood glucose monitoring by the continuous interstitial glucose measurement system (Freestyle Libre) and who regularly wears this device with an achievement of at least 4 scans per day to obtain at least 90% of the possible values
- Patient with HbA1c ≤10.0% less than 3 months
- Patient with a willingness and ability to comply with study requirements and schedule of visits
- Patient who received complete information and signed informed consent
Who cannot join
- Patient with contraindication for rapid or ultra-rapid insulin analogues
- Patient for whom a change of insulin in the next 3 to 6 months is planned
- Women of childbearing age who do not have effective contraception
- Women who are pregnant or breast feeding or plan on becoming pregnant during the study
- Patient taking medication that interferes with interpretation of study results such as chronic corticosteroid therapy
- Patient with a chimio - or radiotherapy is in progress or is planned
Show all 11Show fewer
- Patient abusing substances
- Patient who participated in another clinical study in the four weeks prior to inclusion
- Patient with or suspected of having any physical, psychological or cognitive disorders interfering with adherence to insulin therapy by pump, or compliance with dietary advice, or completion of the patient's diary
- Patient unable to comply with clinical guidelines, and unable to comply with 3-month follow-up
- Patient unable to understand information, to sign informed consent or to manage glycemic sensor
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition
Besançon
Sophie BOROT, 0033381668229, sophie.borot@univ-fcomte.fr
Sophie BOROT
- Recruiting
Service d'endocrinologie et maladies métaboliques
Dijon
Sabine RUDONI, 0033380293453, sabine.rudoni@chu-dijon.fr
Sabine RUDONI
- Recruiting
Service d'Endocrinologie, Diabétologie et Nutrition
Nancy
Siham BENZIRAR, 0033383155028, s.benzirar@chru-nancy.fr
Bruno GUERCI
- Not yet recruiting
Service Endocrinologie Diabète Nutrition
Reims
Sandrine PLISSON-RONEZ, 0033326787159, splisson-ronez@chu-reims.fr
Céline LUKAS-CROISIER
- Not yet recruiting
Structure d'Endocrinologie, Diabète et Nutrition
Strasbourg
Stéphanie Kocakaya, 0033388116603, Stephanie.KOCAKAYA@chru-strasbourg.fr
Nathalie JEANDIDIER
- Not yet recruiting
Service de diabétologie, maladies métaboliques et nutrition
Toulouse
Laurent CAZALS, 0033561323361, cazals.l@chu-toulouse.fr
Hélène HANAIRE
About this study
Official title: Evaluation of Insulin Therapy by Multiwave Bolus Based on the Lipid and Protein Content in Addition to the Carbohydrates Content Compared to Insulin Therapy Based Only on the Carbohydrates Content in type1 Diabetes Treated by Insulin Pump
The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of insulin is calculated on the basis of protein and fat content in food intake, in addition to that of carbohydrates in T1D patients treated by insulin pump. The study is planned to recruit 150 patients with type1 diabetes already practicing functional insulin therapy based on carbohydrate counting in meals. We will therefore study the effect on continuous glucose measured by subcutaneous sensor, of meal bolus adjustments by comparing two groups of T1D patients:
- Groupe A takes into account the lipid and protein content in addition to the carbohydrate content
- Group B takes into account the carbohydrate content only At randomization, all patients receive dietary and adjustment of bolus doses instructions according to the randomization group. They have to apply these instructions for 3 months. At the end of 3 months, the study groups will be under glucose monitoring during two weeks in the Outpatient Clinic but returns to the investigational site in hospital to download data from the continuous measurement of glucose. In addition, we propose a period of extension similar to that of the main period, namely 3 months of application of dietetic and adaptation of bolus doses instructions and 2 weeks of continuous measurement of glucose.
During each 2 weeks period will be assessed specific glucose parameters in the post-prandial period over 4hours (glycemic sensor values in the glucose range between 70-140 mg / dl, glycemic sensor values in the glucose range between 140 -180 mg /dl and > 180 mg /dl) after taking each meal during the 13 days of Glucose Continuous Measurement (GCM), average daily glucose per meal, average blood glucose over the 13-day period after each meal.
- Conditions
- Type1diabetes
- Being tested
- New functional insulin therapy, functional insulin therapy
- Keywords
- insulin therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New functional insulin therapyOther
Also called FIT based on a Carbohydrate / Lipid / Protein count
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT
functional insulin therapyOther
Also called FIT based on a carbohydrate count only
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A = intervention group (new functional insulin therapy) who adjusts the insulin bolus according to a dose titration algorithm taking into account the lipid and protein content in addition to that of carbohydrates. The functional insulin therapy is based on a Carbohydrate / Lipid / Protein count Receives: Other: New functional insulin therapy |
| Group B | Other | Group B=control group (functional insulin tehrapy) who adjusts the insulin bolus taking into account only the carbohydrate content. The functional insulin therapy is based on a Carbohydrate count only. Receives: Other: functional insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of normoglycemia values to total glucose values
The ratio (expressed as a%) of the number of normoglycemia values over the total number of values collected over the 13-day period of the glucose monitoring
Measured: at 14 weeks since the patient randomization
Secondary outcomes (7)
Continuous Glucose Measurement (CGM)
Specific glycemic parameters in the post-prandial period over 4h (glycemic sensor values in the blood glucose range between 70-140 mg / dl, glycemic sensor values in the blood glucose area between 140 - 180 mg / dL and> 180 Mg / dl) after taking each meal during the 13 days of CGM, average daily glucose per meal, average blood glucose over the 13-day period after each meal
Measured: at 14 weeks and at 28 weeks since the patient randomization
HbA1c
HbA1C dosage to assess glycemic control
Measured: at 14 weeks and at 28 weeks since the patient randomization
Sensor wearing time
Sensor wearing time over the 3-month period and the 13-day CGM recording period
Measured: 12 weeks, 14 weeks, 26 weeks and 28 weeks since the patient randomization
Number of sensor scans
Number of sensor scans performed by the patient with corresponding time periods
Measured: 14 weeks and 28 weeks since the patient randomization
Number of boluses performed
Number of boluses performed over the 13-day period of the CGM
Measured: at 14 weeks and at 28 weeks since the patient randomization
Satisfaction of the patient with regard to his treatment
Patient satisfaction assessed by the DTSQs (status) and DTSQc (change)
Measured: at inclusion, at 12 weeks and 26 weeks since randomisation
Usability of the insulin pump
Evaluate the use of pump functions by patient ex. Bolus calculator, Temporary base rate
Measured: 14 weeks and 28 weeks since the patient randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start10 Oct 2019
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Reims, France, Central Hospital, Toulouse, France, Central Hospital, Strasbourg, France, Central Hospital, Besançon, France, Central Hospital, Dijon, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311516
- Sponsor's protocol ID
- 2017-A02414-49
- Acronym
- EVANEWFIT2
- Status last verified
- Jul 2020
- First submitted
- 12 Oct 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Insulin Therapy by Multiwave Bolus Based on the Lipid and Protein Content in Addition to the Carbohydrates Content Compared to Insulin Therapy Based Only on the Carbohydrates Content in type1 Diabetes Treated by Insulin Pump
- ClinicalTrials.gov ID
- NCT03311516
- Acronym / sponsor ID
- EVANEWFIT2 / 2017-A02414-49
- Conditions
- Type1diabetes
- Keywords
- insulin therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Central Hospital, Reims, France, Central Hospital, Toulouse, France, Central Hospital, Strasbourg, France, Central Hospital, Besançon, France, Central Hospital, Dijon, France
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Oct 2017 (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.
The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of insulin is calculated on the basis of protein and fat content in food intake, in addition to that of carbohydrates in T1D patients treated by insulin pump. The study is planned to recruit 150 patients with type1 diabetes already practicing functional insulin therapy based on carbohydrate counting in meals. We will therefore study the effect on continuous glucose measured by subcutaneous sensor, of meal bolus adjustments by comparing two groups of T1D patients:
- Groupe A takes into account the lipid and protein content in addition to the carbohydrate content
- Group B takes into account the carbohydrate content only At randomization, all patients receive dietary and adjustment of bolus doses instructions according to the randomization group. They have to apply these instructions for 3 months. At the end of 3 months, the study groups will be under glucose monitoring during two weeks in the Outpatient Clinic but returns to the investigational site in hospital to download data from the continuous measurement of glucose. In addition, we propose a period of extension similar to that of the main period, namely 3 months of application of dietetic and adaptation of bolus doses instructions and 2 weeks of continuous measurement of glucose.
During each 2 weeks period will be assessed specific glucose parameters in the post-prandial period over 4hours (glycemic sensor values in the glucose range between 70-140 mg / dl, glycemic sensor values in the glucose range between 140 -180 mg /dl and > 180 mg /dl) after taking each meal during the 13 days of Glucose Continuous Measurement (GCM), average daily glucose per meal, average blood glucose over the 13-day period after each meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: New functional insulin therapyGroup A = intervention group (new functional insulin therapy) who adjusts the insulin bolus according to a dose titration algorithm taking into account the lipid and protein content in addition to that of carbohydrates. The functional insulin therapy is based on a Carbohydrate / Lipid / Protein count |
| Group B | Other | Other: functional insulin therapyGroup B=control group (functional insulin tehrapy) who adjusts the insulin bolus taking into account only the carbohydrate content. The functional insulin therapy is based on a Carbohydrate count only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 diabetic patient for more than one year, practicing functional insulin for at least 3 months but not more than 5 years
- Patient treated with external insulin pump (Medtronic or Omnipod pump)
- Patient performing intermittent blood glucose monitoring by the continuous interstitial glucose measurement system (Freestyle Libre) and who regularly wears this device with an achievement of at least 4 scans per day to obtain at least 90% of the possible values
- Patient with HbA1c ≤10.0% less than 3 months
- Patient with a willingness and ability to comply with study requirements and schedule of visits
Key exclusion criteria (11 listed)
- Patient with contraindication for rapid or ultra-rapid insulin analogues
- Patient for whom a change of insulin in the next 3 to 6 months is planned
- Women of childbearing age who do not have effective contraception
- Women who are pregnant or breast feeding or plan on becoming pregnant during the study
- Patient taking medication that interferes with interpretation of study results such as chronic corticosteroid therapy
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 |
|---|---|---|
| New functional insulin therapyAlso: FIT based on a Carbohydrate / Lipid / Protein countthe patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT | Other | Group A |
| functional insulin therapyAlso: FIT based on a carbohydrate count onlythe patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT | Other | Group B |
Primary outcome
The ratio of normoglycemia values to total glucose values
Time frame: at 14 weeks since the patient randomization
The ratio (expressed as a%) of the number of normoglycemia values over the total number of values collected over the 13-day period of the glucose monitoring
7 secondary outcomes
Continuous Glucose Measurement (CGM)
Time frame: at 14 weeks and at 28 weeks since the patient randomization
HbA1c
Time frame: at 14 weeks and at 28 weeks since the patient randomization
Sensor wearing time
Time frame: 12 weeks, 14 weeks, 26 weeks and 28 weeks since the patient randomization
Number of sensor scans
Time frame: 14 weeks and 28 weeks since the patient randomization
Number of boluses performed
Time frame: at 14 weeks and at 28 weeks since the patient randomization
Satisfaction of the patient with regard to his treatment
Time frame: at inclusion, at 12 weeks and 26 weeks since randomisation
Usability of the insulin pump
Time frame: 14 weeks and 28 weeks since the patient randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New functional insulin therapy and functional insulin therapy in people with Type1diabetes, run by Central Hospital, Nancy, France at 6 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SIHAM BENZIRAR (0033383155028, s.benzirar@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of normoglycemia values to total glucose values (time frame: at 14 weeks since the patient randomization). 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 23 Jul 2020.