Type 1 DiabetesrealFACINCT04233203
Faster Aspart on Insulin-pump Treated T1DM Patients
An observational study of Type 1 Diabetes, run by Jesús Moreno Fernández at 1 site in Spain.
Trial summary
Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin Faster Aspart and Insulin pump
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our consults were eligible.
Who may be able to join
- ≥18 years of age.
- Diagnosed of Type 1 Diabetes Mellitus.
- Be attended in Ciudad Real General University Hospital.
- Current treated with CSII (CSII cohort) during ≥6 months.
- Current treated with insulin Faster Aspart during ≥3 months.
Who cannot join
- Less than 18 years old.
- Other types of diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice
Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.
Read the detailed description
Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.
All clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin Faster Aspart, Insulin pump
- Keywords
- insulin pump, Faster aspart, insulin, glycemic variability
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Faster AspartDrug
Also called Fiasp
Currently receiving Faster Aspart during 3 or more months.
Insulin pumpDevice
Also called Medtronic 640G, Medtronic 670G, T Slim X2, Accucheck Insight
Currently receiving CSII therapy during 6 or more months.
| Study group | Role | What they receive |
|---|---|---|
| Faster Aspart | All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart. Receives: Drug: Insulin Faster Aspart; Device: Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAGE
Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE).
Measured: 3 months
Secondary outcomes (9)
VCo
Differences from basal to 3 months after Faster Aspart initiation Variation Coefficient (VCo).
Measured: 3 months
M100
Differences from basal to 3 months after Faster Aspart initiation on M100.
Measured: 3 months
GRADE
Differences from basal to 3 months after Faster Aspart initiation on Glycemia Risk Assessment Diabetes Equation (GRADE).
Measured: 3 months
J-index
Differences from basal to 3 months after Faster Aspart initiation on J-index.
Measured: 3 months
MODD
Differences from basal to 3 months after Faster Aspart initiation on MODD.
Measured: 3 months
CONGA
Differences from basal to 3 months after Faster Aspart initiation on CONGA.
Measured: 3 months
HbA1c
Differences from basal to 3 months after Faster Aspart initiation on Hemoglobin A1C (HbA1C).
Measured: 3 months
Hypoglycemic frequency
Differences from basal to 3 months after Faster Aspart initiation on hypoglycemic frequency.
Measured: 3 months
TIR-TAR-TUR
- Differences from basal to 3 months after Faster Aspart initiation on time in range, time above range and time under range.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start31 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesús Moreno Fernández
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Responsible party
- Sponsor-investigator, Jesús Moreno Fernández, Castilla-La Mancha Health Service
- Investigators
- Jose Alberto Garcia Seco, RN, Study chair, Ciudad Real General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233203
- Sponsor's protocol ID
- C-302
- Acronym
- realFACI
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Moreno-Fernandez J, Garcia-Seco JA, Virlaboa-Cebrian R, Seco AM, Munoz-Rodriguez JR, Gomez-Romero FJ. Faster-acting insulin aspart reduces glycaemic variability in sensor-augmented pump treated type 1 diabetes patients. Endocrinol Diabetes Nutr (Engl Ed). 2023 Jun-Jul;70(6):389-395. doi: 10.1016/j.endien.2021.12.012.
PubMed 37356876
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Insulin Faster Aspart on Continuous Subcutaneous Insulin Infusion Treated Adult Type 1 Diabetes Mellitus Patients in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT04233203
- Acronym / sponsor ID
- realFACI / C-302
- Conditions
- Type 1 Diabetes
- Keywords
- insulin pump, Faster aspart, insulin, glycemic variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jesús Moreno FernándezUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Jan 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.
Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.
Detailed description
Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.
All clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).
Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value < 0.05 was considered statistically significant.
The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Faster Aspart | – | Drug: Insulin Faster Aspart, Device: Insulin pumpAll T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII and insulin Faster Aspart. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years of age) T1DM patients on CSII with Faster Aspart attended to care in our consults were eligible.
Key inclusion criteria (5 listed)
- ≥18 years of age.
- Diagnosed of Type 1 Diabetes Mellitus.
- Be attended in Ciudad Real General University Hospital.
- Current treated with CSII (CSII cohort) during ≥6 months.
- Current treated with insulin Faster Aspart during ≥3 months.
Key exclusion criteria (2 listed)
- Less than 18 years old.
- Other types of diabetes mellitus.
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 |
|---|---|---|
| Insulin Faster AspartAlso: FiaspCurrently receiving Faster Aspart during 3 or more months. | Drug | Faster Aspart |
| Insulin pumpAlso: Medtronic 640G, Medtronic 670G, T Slim X2, Accucheck InsightCurrently receiving CSII therapy during 6 or more months. | Device | Faster Aspart |
Primary outcome
MAGE
Time frame: 3 months
Differences from basal to 3 months after Faster Aspart initiation on Mean Amplitude of Glucose Excursions (MAGE).
9 secondary outcomes
VCo
Time frame: 3 months
M100
Time frame: 3 months
GRADE
Time frame: 3 months
J-index
Time frame: 3 months
MODD
Time frame: 3 months
CONGA
Time frame: 3 months
HbA1c
Time frame: 3 months
Hypoglycemic frequency
Time frame: 3 months
TIR-TAR-TUR
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 37356876Moreno-Fernandez J, Garcia-Seco JA, Virlaboa-Cebrian R, Seco AM, Munoz-Rodriguez JR, Gomez-Romero FJ. Faster-acting insulin aspart reduces glycaemic variability in sensor-augmented pump treated type 1 diabetes patients. Endocrinol Diabetes Nutr (Engl Ed). 2023 Jun-Jul;70(6):389-395. doi: 10.1016/j.endien.2021.12.012.
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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.
Jose Alberto Garcia Seco, RN study chair
Ciudad Real General University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Jesús Moreno Fernández at 1 site in Spain.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 1 Feb 2021. 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MAGE (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04233203, which also lists 1 linked publication.
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 1 Feb 2021.