Type 1 Diabetes Mellitusreal-ECIMINCT03793283
Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice
An observational study of Type 1 Diabetes Mellitus, run by Castilla-La Mancha Health Service at 1 site in Spain.
Trial summary
Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CSII and Multiple dose insulin injections
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII. MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.
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) or MDI (MDI cohort) during ≥6 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 Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Type 1 Diabetes Mellitus Adult Patients in Routine Clinical Practice
Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
Read the detailed description
Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in T1DM adult patients in routine clinical practice.
All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®, Emminens eConecta® and FreeStyle Libre®).
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 Mellitus
- Being tested
- CSII, Multiple dose insulin injections
- 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.
CSIIDevice
Also called Continuous subcutaneous insulin infusion
Currently receiving CSII therapy during 6 or more months.
Multiple dose insulin injectionsDrug
Also called MDI
Currently receiving MDI therapy during 6 or more months.
| Study group | Role | What they receive |
|---|---|---|
| Continous Subcutaneous Insulin Infusion | All T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII.
Forty-five patients are actually treated with CSII in our hospital. Receives: Device: CSII | |
| Multiple dose insulin injections (MDI): | Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI.
MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database. Receives: Drug: Multiple dose insulin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Hemoglobin A1C (HbA1C).
Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.
Measured: 1 year
Secondary outcomes (13)
Hypoglycemia frequency.
Between group hypoglycemic frequency difference. Unit of measure: daily number of events of glycemic values <70 mg/dL.
Measured: 1 year
Concentration of Capillary blood glucose.
Between group capillary blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
Measured: 1 year
Concentration of Interstitial blood glucose.
Between group interstitial blood glucose difference. Physiological parameter. Unit of measure: mg/dL.
Measured: 1 year
Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.
Glycemic variability expressed as coefficient of variation of capilary/interstitial blood glucose.
Physiological parameter. Unit of measure: %.
Measured: 1 year
Glycemic variability: standar deviation of capilary/interstitial blood glucose.
Glycemic variability expressed as standar deviation of capilary/interstitial blood glucose.
Physiological parameter. Unit of measure: mg/dL.
Measured: 1 year
Self-monitoring of blood glucose (SMBG) daily frequency
Self-monitoring of blood glucose (SMBG) daily frequency. Unit of measure: number of daily controls.
Measured: 1 year
Severe hypoglycemia frequency.
Number of events during the last year of severe hypoglycemia frequency defined as any glycemic value <70 mg/dL requiring assitance from another person to treat.
Unit of measure: number of events during the last 12 months.
Measured: 1 year
Weight.
Between group weight differences. Physiological parameter. Unit of measure: Kg.
Measured: 1 year
Insuline dose.
Daily insulin doses (basal and bolus) and bolus insulin daily frequency. Unit of measure: IU/Kg/24h.
Measured: 1 year
Diabetes quality of life (DQOL).
Diabetes related quality of life (EsDQOL questionnary). Spanihs version of DQOL questionnary. Unit of measure: Questionnary score. Higher values represent a worse outcome. Forty-six questions in four categories: Satisfaction (15), Impact (20), Social/vacational worryness (7) and Diabetes related worryness (4). Each question score from 1 to 5 points.
Total minimum score 46, total maximum score 230. Satisfaction range from 15 to 75, Impact range from 20 to 100, Social/vacational worryness range from 7 to 35 and Diabetes related worryness range from 4 to 20.
Measured: 1 year.
Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable
Satisfaction with the treatment received (Diabetes Treatment Satisfaction Questionnaire Stable, EsDTSQs questionnary).
Spanish version of DTSQs questionnary. Unit of measure: Questionnary score. Higher values represent a better outcome. Eight questions with seven possible answers ranged each one from 0 to 6 points. First six questions compute a subscore ranged from 0 to 36 points. Two last questions are independtly analyzed (each one range from 0 to 6 points).
Measured: 1 year
Unawareness hypoglycemia.
Unawareness hypoglycemia frequency (Clarke questionnary). Unit of measure: Questionnary score. Higher values represent a worse outcome. Eight questions with each answer categorized in normal (A) or abnormal (R). Total sum of abnormal (R) answers classifed patients in normal perception (range from 0 to 2), indeterminate percepction (range=3) and abnormal perception (range from 4 to 8).
Measured: 1 year.
Safety related adverse events.
Serious related adverse events: diabetes ketoacidosis, hospitalization, death. Unit of measure: number of events.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha, Universidad de Córdoba
- Responsible party
- Principal investigator, Jesús Moreno Fernández, Castilla-La Mancha Health Service
- Investigators
- Jesus Moreno-Fernandez, PhD, Principal investigator, Castilla-La Mancha Public Health Service.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793283
- Sponsor's protocol ID
- C-225
- Acronym
- real-ECIMI
- Status last verified
- Jan 2020
- First submitted
- 27 Dec 2018
- Last updated
- 18 Jan 2020
- 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 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Type 1 Diabetes Mellitus Adult Patients in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03793283
- Acronym / sponsor ID
- real-ECIMI / C-225
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha, Universidad de Córdoba
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Jan 2019 (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 study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.
Detailed description
Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in T1DM adult patients in routine clinical practice.
All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®, Emminens eConecta® and FreeStyle Libre®).
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
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous Subcutaneous Insulin Infusion | – | Device: CSIIAll T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII. Forty-five patients are actually treated with CSII in our hospital. |
| Multiple dose insulin injections (MDI): | – | Drug: Multiple dose insulin injectionsForty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with MDI. MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Forty-five T1DM adult patients attended in Ciudad Real General University Hospital and treated with CSII. MDI patients will be selected through simple random sampling (1:1) from our T1DM patient database.
Key inclusion criteria (4 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) or MDI (MDI cohort) during ≥6 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 |
|---|---|---|
| CSIIAlso: Continuous subcutaneous insulin infusionCurrently receiving CSII therapy during 6 or more months. | Device | Continous Subcutaneous Insulin Infusion |
| Multiple dose insulin injectionsAlso: MDICurrently receiving MDI therapy during 6 or more months. | Drug | Multiple dose insulin injections (MDI): |
Primary outcome
Concentration of Hemoglobin A1C (HbA1C).
Time frame: 1 year
Between group hemoglobin A1C (HbA1C) difference. Physiological parameter. Unit of measure: %.
13 secondary outcomes
Hypoglycemia frequency.
Time frame: 1 year
Concentration of Capillary blood glucose.
Time frame: 1 year
Concentration of Interstitial blood glucose.
Time frame: 1 year
Glycemic variability: coefficient of variation of capilary/interstitial blood glucose.
Time frame: 1 year
Glycemic variability: standar deviation of capilary/interstitial blood glucose.
Time frame: 1 year
Self-monitoring of blood glucose (SMBG) daily frequency
Time frame: 1 year
Severe hypoglycemia frequency.
Time frame: 1 year
Weight.
Time frame: 1 year
Insuline dose.
Time frame: 1 year
Diabetes quality of life (DQOL).
Time frame: 1 year.
Satisfaction with the treatment received: Diabetes Treatment Satisfaction Questionnaire Stable
Time frame: 1 year
Unawareness hypoglycemia.
Time frame: 1 year.
Safety related adverse events.
Time frame: 1 year
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 18 Jan 2020.
- 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. This study is not recruiting at the moment.
Jesus Moreno-Fernandez, PhD principal investigator
Castilla-La Mancha Public Health Service.
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 Mellitus, run by Castilla-La Mancha Health Service 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 4 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 18 Jan 2020. 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?
Concentration of Hemoglobin A1C (HbA1C). (time frame: 1 year). 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 Jan 2020.