Type 1 Diabetes Clinical Trial
Official title:
Clinical Effects of Intermitent Continuous Glucose Monitoring (Flash) in Adult Patients With Type 1 Diabetes in an Spanish Public Health System
| NCT number | NCT05095610 |
| Other study ID # | C-455 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2021 |
| Est. completion date | May 6, 2022 |
| Verified date | July 2022 |
| Source | Castilla-La Mancha Health Service |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1121 |
| Est. completion date | May 6, 2022 |
| Est. primary completion date | March 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 99 Years |
| Eligibility | Inclusion Criteria: - Presence of Type 1 diabetes. - Age >18 years. - Patients previously followed in the DIACAM study. Exclusion Criteria: - Any other kinds of diabetes. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Albacete University Hospital | Albacete | |
| Spain | La Mancha- Centro Hospital | Alcázar De San Juan | Ciudad Real |
| Spain | Obispo Rafael Torija, St. | Ciudad Real | |
| Spain | Guadalajara University Hospital | Guadalajara | |
| Spain | Santa Barbara Hospital | Puertollano | Ciudad Real |
| Spain | Virgen del Prado Hospital | Talavera De La Reina | Toledo |
| Spain | Toledo University Hospital | Toledo | |
| Spain | Virgen de Altagracia Hospital | Valdepeñas | Ciudad Real |
| Lead Sponsor | Collaborator |
|---|---|
| Castilla-La Mancha Health Service |
Spain,
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. Epub 2012 Oct 4. English, Spanish. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c difference | Difference in HbA1c before initiating iCGM compared with HbA1c levels after one year of treatment. | 1 year | |
| Secondary | Frequency of SBGM | Daily number of blood capilary test fot glycemia determination. | 1 year | |
| Secondary | Adherence to Flash | Time of use of Flash glucose monitoring (% possible time of use) | 1 year | |
| Secondary | TIR | Time in range (TIR, 3.9-10 mmol/L) of the interstitial glucose | 1 year | |
| Secondary | TAR | Time above range (TAR, >10 mmol/L) of the interstitial glucose | 1 year | |
| Secondary | TBR | Time bellow range (TBR, <3.9 mmol/L) of the interstitial glucose | 1 year | |
| Secondary | %CV | Percentage of the variation coefficient (%, >36% is considered high levels) | 1 year | |
| Secondary | Body weight | Total corporal body weight (Kg) | 1 year | |
| Secondary | Insulin dose | Daily insulin dose requirements (UI/Kg/d) | 1 year |
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