Type 1 DiabetesNCT05095610
Clinical Effects of Intermitent Continuous Glucose Monitoring in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Castilla-La Mancha Health Service at 8 sites in Spain.
Trial summary
Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Flash
- Type of treatment
- Medical device
- How many people
- 1,121 participants
- Where
- 8 sitesSpain
- Study dates
- 1 Nov 2021to 6 May 2022
- 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 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients >18 years with type 1 diabetes and previously followed in the DIACAM study (see reference).
Who may be able to join
- Presence of Type 1 diabetes.
- Age >18 years.
- Patients previously followed in the DIACAM study.
Who cannot join
- Any other kinds of diabetes.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Albacete University Hospital
Albacete, 02006
La Mancha- Centro Hospital
Alcázar de San Juan, Ciudad Real, 13600
Obispo Rafael Torija, St.
Ciudad Real, 13005
Guadalajara University Hospital
Guadalajara, 19002
Santa Barbara Hospital
Puertollano, Ciudad Real, 13500
Virgen del Prado Hospital
Talavera de la Reina, Toledo, 45600
Toledo University Hospital
Toledo, 45007
Virgen de Altagracia Hospital
Valdepeñas, Ciudad Real, 13300
About this study
Official title: Clinical Effects of Intermitent Continuous Glucose Monitoring (Flash) in Adult Patients With Type 1 Diabetes in an Spanish Public Health System
Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.
Read the detailed description
Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.
All clinical variables are gathered from chart review. Data analysis is conducted using SPSS statistic software. Results are presented as mean +/- SD values. A paired Student´s t-test or Wilconxon signed test were used fr the analysis differences. Comparison between proportions were analyzed using a chi-square test. A P value <0.05 was considered statistically significant.
The protocolo was apporved by the reference Castilla-La Mancha Public Health Service Ethic Commitee. All participants provided written consent.
- Conditions
- Type 1 Diabetes
- Being tested
- Flash
- Keywords
- type 1 diabetes, intermitent continous glucose monitoring, Flash
- Medical subject headings
- Diabetes Mellitus, Type 1, photopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlashDevice
Also called FreeStyle Libre, iCGM
Use of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Adult Type 1 Diabetes | All adult patients with type 1 diabetes previously followed in the DIACAM study (see bellow reference).
Sastre J, Pinés PJ, Moreno J, Aguirre M, Blanco B, Calderón D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Receives: Device: Flash |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c difference
Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment.
Measured: 1 year
Secondary outcomes (8)
Frequency of SBGM
Daily number of blood capilary test fot glycemia determination.
Measured: 1 year
Adherence to Flash
Time of use of Flash glucose monitoring (% possible time of use)
Measured: 1 year
TIR
Time in range (TIR, 3.9-10 mmol/L) of the interstitial glucose
Measured: 1 year
TAR
Time above range (TAR, >10 mmol/L) of the interstitial glucose
Measured: 1 year
TBR
Time bellow range (TBR, <3.9 mmol/L) of the interstitial glucose
Measured: 1 year
%CV
Percentage of the variation coefficient (%, >36% is considered high levels)
Measured: 1 year
Body weight
Total corporal body weight (Kg)
Measured: 1 year
Insulin dose
Daily insulin dose requirements (UI/Kg/d)
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 posted27 Oct 2021
- Study start1 Nov 2021
- Primary completion30 Mar 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cross-sectional
- Enrolment
- 1,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095610
- Sponsor's protocol ID
- C-455
- Status last verified
- Jul 2022
- First submitted
- 30 Sep 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: After approval for the rest ot investigators.
Publications
Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish.
PubMed 23039989Moreno-Fernandez J, Sastre J, Pines P, Calderon-Vicente D, Gargallo J, Munoz-Rodriguez JR. To evaluate the use and clinical effect of intermittently scanned continuous glucose monitoring in adults with type 1 diabetes: Results of a multicentre study. Endocrinol Diabetes Nutr (Engl Ed). 2023 Apr;70(4):270-276. doi: 10.1016/j.endien.2023.03.013.
PubMed 37116972
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Intermitent Continuous Glucose Monitoring (Flash) in Adult Patients With Type 1 Diabetes in an Spanish Public Health System
- ClinicalTrials.gov ID
- NCT05095610
- Acronym / sponsor ID
- C-455
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, intermitent continous glucose monitoring, Flash
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,121 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 27 Oct 2021 (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 cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.
Detailed description
Observational cross-sectional multicenter study about clinical effect of intermitent continuous glucose monitoring (Flash) in adult type 1 diabetes patients in an Spanish public health system.
All clinical variables are gathered from chart review. Data analysis is conducted using SPSS statistic software. Results are presented as mean +/- SD values. A paired Student´s t-test or Wilconxon signed test were used fr the analysis differences. Comparison between proportions were analyzed using a chi-square test. A P value <0.05 was considered statistically significant.
The protocolo was apporved by the reference Castilla-La Mancha Public Health Service Ethic Commitee. All participants provided written consent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Type 1 Diabetes | – | Device: FlashAll adult patients with type 1 diabetes previously followed in the DIACAM study (see bellow reference). Sastre J, Pinés PJ, Moreno J, Aguirre M, Blanco B, Calderón D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients >18 years with type 1 diabetes and previously followed in the DIACAM study (see reference).
Key inclusion criteria (3 listed)
- Presence of Type 1 diabetes.
- Age >18 years.
- Patients previously followed in the DIACAM study.
Key exclusion criteria (1 listed)
- Any other kinds of diabetes.
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 |
|---|---|---|
| FlashAlso: FreeStyle Libre, iCGMUse of the device FreeStyle Libre, only commercialized system for intermitent continuous glucose monitoring. | Device | Adult Type 1 Diabetes |
Primary outcome
HbA1c difference
Time frame: 1 year
Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment.
8 secondary outcomes
Frequency of SBGM
Time frame: 1 year
Adherence to Flash
Time frame: 1 year
TIR
Time frame: 1 year
TAR
Time frame: 1 year
TBR
Time frame: 1 year
%CV
Time frame: 1 year
Body weight
Time frame: 1 year
Insulin dose
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 19 Jul 2022.
- Background: PubMed 23039989Sastre J, Pines PJ, Moreno J, Aguirre M, Blanco B, Calderon D, Herranz S, Roa C, Lopez J; Grupo de estudio DIACAM 1. Metabolic control and treatment patterns in patients with type 1 diabetes in Castilla-La Mancha: the DIAbetes tipo 1 in Castilla La Mancha study. Endocrinol Nutr. 2012 Nov;59(9):539-46. doi: 10.1016/j.endonu.2012.07.003. Epub 2012 Oct 4. English, Spanish.
- Derived from this study: PubMed 37116972Moreno-Fernandez J, Sastre J, Pines P, Calderon-Vicente D, Gargallo J, Munoz-Rodriguez JR. To evaluate the use and clinical effect of intermittently scanned continuous glucose monitoring in adults with type 1 diabetes: Results of a multicentre study. Endocrinol Diabetes Nutr (Engl Ed). 2023 Apr;70(4):270-276. doi: 10.1016/j.endien.2023.03.013.
- Individual participant dataSharing planned: Undecided. After approval for the rest ot investigators.
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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.
8 sites 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 Castilla-La Mancha Health Service at 8 sites 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 3 inclusion and 1 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
HbA1c difference (time frame: 1 year). 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 NCT05095610, which also lists 2 linked publications.
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 19 Jul 2022.