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SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01087541
Acronym
SEGUDIAB
Enrollment
6830
Registered
2010-03-16
Start date
2008-01-31
Completion date
2010-06-30
Last updated
2011-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Patient's Safety, Diabetes mellitus, Public Health for professionals, Safety, Public health

Brief 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.

Interventions

BEHAVIORALEducational program 6-hour standardized

6-hour standardized program for adults ( doctors and nurses )

Sponsors

Department of Health, Generalitat de Catalunya
CollaboratorOTHER_GOV
Fundación Avedis Donabedian
CollaboratorUNKNOWN
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Glycosylated Haemoglobin A1c at StartBaseline
Glycosylated Haemoglobin A1c at 6 Months6 monthsGlycohemoglobin A1c at 6 months.

Secondary

MeasureTime frame
BMI ( Body Mass Index ) at StartBaseline
BMI at 6 Months6 months
Blood Pressure ( Systolic / Diastolic )Baseline
Systolic and Diastolic Blood Pressure6 months

Countries

Spain

Participant flow

Participants by arm

ArmCount
Intervention
Behavioural program of education for health professionals of the study
3,307
Control Group
Usual healthcare of diabetics patients
3,523
Total6,830

Baseline characteristics

CharacteristicInterventionControl GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
320 Participants522 Participants842 Participants
Age, Categorical
Between 18 and 65 years
2987 Participants3001 Participants5988 Participants
Region of Enrollment
Spain
3307 participants3523 participants6830 participants
Sex: Female, Male
Female
1907 Participants2000 Participants3907 Participants
Sex: Female, Male
Male
1400 Participants1523 Participants2923 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
2 / 521 / 87
serious
Total, serious adverse events
0 / 3,3070 / 3,523

Outcome results

Primary

Glycosylated Haemoglobin A1c at 6 Months

Glycohemoglobin A1c at 6 months.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
InterventionGlycosylated Haemoglobin A1c at 6 Months6.81 PercentageStandard Deviation 1.49
Control GroupGlycosylated Haemoglobin A1c at 6 Months7.00 PercentageStandard Deviation 1.64
p-value: <0.0195% CI: [0, 1]t-test, 2 sided
Primary

Glycosylated Haemoglobin A1c at Start

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
InterventionGlycosylated Haemoglobin A1c at Start6.64 PercentageStandard Deviation 1.6
Control GroupGlycosylated Haemoglobin A1c at Start6.76 PercentageStandard Deviation 1.67
Secondary

Blood Pressure ( Systolic / Diastolic )

Time frame: Baseline

ArmMeasureGroupValue (MEAN)Dispersion
InterventionBlood Pressure ( Systolic / Diastolic )Diastolic72.6 mmHgStandard Deviation 11.9
InterventionBlood Pressure ( Systolic / Diastolic )Systolic130.3 mmHgStandard Deviation 18.5
Control GroupBlood Pressure ( Systolic / Diastolic )Systolic131.5 mmHgStandard Deviation 18.6
Control GroupBlood Pressure ( Systolic / Diastolic )Diastolic73.7 mmHgStandard Deviation 11.8
Secondary

BMI at 6 Months

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
InterventionBMI at 6 Months30.0 kg/m2Standard Deviation 5.2
Control GroupBMI at 6 Months30.1 kg/m2Standard Deviation 5.8
Secondary

BMI ( Body Mass Index ) at Start

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
InterventionBMI ( Body Mass Index ) at Start26.9 kg/m2Standard Deviation 9.7
Control GroupBMI ( Body Mass Index ) at Start27.1 kg/m2Standard Deviation 9.6
Secondary

Systolic and Diastolic Blood Pressure

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
InterventionSystolic and Diastolic Blood PressureSystolic130.2 mmHgStandard Deviation 18.4
InterventionSystolic and Diastolic Blood PressureDiastolic72.9 mmHgStandard Deviation 10.5
Control GroupSystolic and Diastolic Blood PressureSystolic129.9 mmHgStandard Deviation 19.5
Control GroupSystolic and Diastolic Blood PressureDiastolic76.2 mmHgStandard Deviation 12.8
p-value: <0.00195% CI: [2, 15]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026