SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

Diabetes Mellitus Clinical Trial

— SEGUDIAB  

Official title:

SEGUDIAB Study: Safety in Diabetic Patients. Evaluation of an Educational Program for the Professionals to Improve the Safety in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087541
• Other study ID #: SEGUDIAB
• Status: Completed
• Phase: N/A
• First received: March 15, 2010
• Last updated: March 27, 2011
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2011
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6830
• Est. completion date: June 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Educational program 6-hour standardized
6-hour standardized program for adults ( doctors and nurses )

Locations

Country	Name	City	State
Spain	Primary Health Care. Catalan Health Institute. Tarragona-Reus	Reus	Tarragona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Department of Health, Generalitat de Catalunya, Fundación Avedis Donabedian

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin A1c at Start		Baseline	No
Primary	Glycosylated Haemoglobin A1c at 6 Months	Glycohemoglobin A1c at 6 months.	6 months	No
Secondary	BMI ( Body Mass Index ) at Start		Baseline	No
Secondary	BMI at 6 Months		6 months	No
Secondary	Blood Pressure ( Systolic / Diastolic )		Baseline	No
Secondary	Systolic and Diastolic Blood Pressure		6 months	No