N/A
N=6,830
SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01087541 ↗Enrolled (actual)
6,830
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Glycosylated Haemoglobin A1c at Start — 6.64; 6.76 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational program 6-hour standardized (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Haemoglobin A1c at Start |
6.64; 6.76 | — |
| PRIMARY Glycosylated Haemoglobin A1c at 6 Months |
6.81; 7.00 | <0.01 sig |
| SECONDARY BMI ( Body Mass Index ) at Start |
26.9; 27.1 | — |
| SECONDARY BMI at 6 Months |
30.0; 30.1 | — |
| SECONDARY Blood Pressure ( Systolic / Diastolic ) |
130.3; 131.5; 72.6; 73.7 | — |
| SECONDARY Systolic and Diastolic Blood Pressure |
130.2; 129.9; 72.9; 76.2 | <0.001 sig |
Summary
The safety in the diabetic patient refer so much to the accuracy of the treatment and to the handling of the diabetic in security topics. Therefore, is not only an economic question, but a more global concept that means to receive an accurate sanitary attention in line with the available evidences nowadays.
OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is followed of an improvement in the safety of the diabetic patients.
METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA) with a random distribution of the educative intervention to realize on the sanitary professionals (5 intervention/5 control). The intervention is an educative system on adults, brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the diabetics. The group control follows his usual clinical practice on the diabetics.
The participation was voluntary. The centres have been matched, being comparable in population and other characteristics, except the specific intervention; ranging between the 6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected only between 45 until 75 years old as operative age group of the 45 until the 75 years like operative aim.
Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the informatic software for primary care.
Exclusion criteria: serious or terminal illness or patients controlled exclusively by specialists.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of diabetes
- Aged between 45 and 75 years
Exclusion Criteria
- No data in informatic system
- Severe illness
- Controlled only by specialists
Data sourced from ClinicalTrials.gov (NCT01087541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.