Trial Outcomes & Findings for SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients (NCT NCT01087541)
NCT ID: NCT01087541
Last Updated: 2011-03-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6830 participants
Primary outcome timeframe
Baseline
Results posted on
2011-03-29
Participant Flow
Participant milestones
| Measure |
Intervention
Behavioural program of education for health professionals of the study
|
Control Group
Usual healthcare of diabetics patients
|
|---|---|---|
|
Overall Study
STARTED
|
3307
|
3523
|
|
Overall Study
COMPLETED
|
3307
|
3523
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients
Baseline characteristics by cohort
| Measure |
Intervention
n=3307 Participants
Behavioural program of education for health professionals of the study
|
Control Group
n=3523 Participants
Usual healthcare of diabetics patients
|
Total
n=6830 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2987 Participants
n=93 Participants
|
3001 Participants
n=4 Participants
|
5988 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
320 Participants
n=93 Participants
|
522 Participants
n=4 Participants
|
842 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1907 Participants
n=93 Participants
|
2000 Participants
n=4 Participants
|
3907 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1400 Participants
n=93 Participants
|
1523 Participants
n=4 Participants
|
2923 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
3307 participants
n=93 Participants
|
3523 participants
n=4 Participants
|
6830 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Intervention
n=3307 Participants
Behavioural program of education for health professionals of the study
|
Control Group
n=3523 Participants
Usual healthcare of diabetics patients
|
|---|---|---|
|
Glycosylated Haemoglobin A1c at Start
|
6.64 Percentage
Standard Deviation 1.60
|
6.76 Percentage
Standard Deviation 1.67
|
PRIMARY outcome
Timeframe: 6 monthsGlycohemoglobin A1c at 6 months.
Outcome measures
| Measure |
Intervention
n=3307 Participants
Behavioural program of education for health professionals of the study
|
Control Group
n=3523 Participants
Usual healthcare of diabetics patients
|
|---|---|---|
|
Glycosylated Haemoglobin A1c at 6 Months
|
6.81 Percentage
Standard Deviation 1.49
|
7.00 Percentage
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Intervention
n=3307 Participants
Behavioural program of education for health professionals of the study
|
Control Group
n=3523 Participants
Usual healthcare of diabetics patients
|
|---|---|---|
|
BMI ( Body Mass Index ) at Start
|
26.9 kg/m2
Standard Deviation 9.7
|
27.1 kg/m2
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Intervention
n=3307 Participants
Behavioural program of education for health professionals of the study
|
Control Group
n=3523 Participants
Usual healthcare of diabetics patients
|
|---|---|---|
|
BMI at 6 Months
|
30.0 kg/m2
Standard Deviation 5.2
|
30.1 kg/m2
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Intervention
n=3307 Participants
Behavioural program of education for health professionals of the study
|
Control Group
n=3523 Participants
Usual healthcare of diabetics patients
|
|---|---|---|
|
Blood Pressure ( Systolic / Diastolic )
Systolic
|
130.3 mmHg
Standard Deviation 18.5
|
131.5 mmHg
Standard Deviation 18.6
|
|
Blood Pressure ( Systolic / Diastolic )
Diastolic
|
72.6 mmHg
Standard Deviation 11.9
|
73.7 mmHg
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Intervention
n=3307 Participants
Behavioural program of education for health professionals of the study
|
Control Group
n=3523 Participants
Usual healthcare of diabetics patients
|
|---|---|---|
|
Systolic and Diastolic Blood Pressure
Systolic
|
130.2 mmHg
Standard Deviation 18.4
|
129.9 mmHg
Standard Deviation 19.5
|
|
Systolic and Diastolic Blood Pressure
Diastolic
|
72.9 mmHg
Standard Deviation 10.5
|
76.2 mmHg
Standard Deviation 12.8
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=52 participants at risk；n=3307 participants at risk
Intervention group: educational program
|
Control Group
n=87 participants at risk；n=3523 participants at risk
Usual healthcare
|
|---|---|---|
|
Investigations
Drug interactions not serious
|
3.8%
2/52 • Number of events 2 • 6 months
Serious events are death or another event due to the study's protocol. As this is an educational project in professionals, we had been not any serious event.
|
1.1%
1/87 • Number of events 1 • 6 months
Serious events are death or another event due to the study's protocol. As this is an educational project in professionals, we had been not any serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place