Trial Outcomes & Findings for Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS) (NCT NCT01220557)
NCT ID: NCT01220557
Last Updated: 2021-08-17
Results Overview
Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.
COMPLETED
NA
160 participants
Baseline and 6 months
2021-08-17
Participant Flow
The participants were recruited in 23 outpatient study centres, which were located all over Germany. A study centre was defined as a medical practice run by a diabetologist and a diabetes educator or diabetes nurse.
Participant milestones
| Measure |
PRIMAS Group
PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
|
Control Group
The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
79
|
|
Overall Study
COMPLETED
|
75
|
74
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
PRIMAS Group
PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
|
Control Group
The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
attended less than 6 lessons
|
1
|
2
|
Baseline Characteristics
Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
Baseline characteristics by cohort
| Measure |
PRIMAS Group
n=81 Participants
PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
|
Control Group
n=79 Participants
The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
45.1 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
81 participants
n=5 Participants
|
79 participants
n=7 Participants
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsDifference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.
Outcome measures
| Measure |
PRIMAS Group
n=75 Participants
PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
|
Control Group
n=74 Participants
The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
|
|---|---|---|
|
Changes in Glycemic Control Measured by A1c
|
-0.4 Changes in A1c in percentage points
Standard Deviation 1.0
|
0.0 Changes in A1c in percentage points
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 6 monthTo assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthThe hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 month follow upEmpowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthThe Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 month follow upDiabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 month follow upDepressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 Month Follow upA German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 Month Follow upSatisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 month Follow upPatients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).
Outcome measures
Outcome data not reported
Adverse Events
PRIMAS Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Norbert Hermanns, PhD
Forschungsinstitut der Diabetes Akademie Mergentheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place