An interventional study of PRIMAS and DTTP in Type 1 Diabetes, sponsored by Forschungsinstitut der Diabetes Akademie Mergentheim. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-17.
Sponsored by Forschungsinstitut der Diabetes Akademie Mergentheim · Not applicable, Interventional, and Treatment
This study is a randomized prospective trial with 6-month follow up. A non-inferiority hypothesis is tested. A new developed treatment and education programme for type 1 diabetic patients (PRIMAS) will be tested compared to an established treatment and education programme (German DTTP). Primary outcome variable is glycemic control at 6-month follow up. Secondary outcome variables are: diabetes knowledge, diabetes related distress, depressive symptoms, diabetes self-efficacy, self-care behavior, attitudes towards diabetes and insulin treatment, hypoglycemia awareness.
Both programmes consists of 12 lessons with a length of 90 minutes. Eligible type 1 diabetic patients in a diabetologist practice are pooled and randomised either to the new developed PRIMAS programme or to an established education programme for type 1 diabetic patients (DTTP - Treatment and education programme for intensified insulin treatment) as an active comparator.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 160 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Forschungsinstitut der Diabetes Akademie Mergentheim is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
type 1 diabetes, diabetes duration > 4 weeks, age 18 - 75 years, BMI 20 - 40 kg/m², A1c 7 - 13 %, ability to understand, speak and write German language, written informed consent.
Exclusion criteria:
current treatment of psychological or psychiatric disorder, dementia or severe cognitive impairment, severe organic disease (e.g. terminal renal disease, cancer with poor prognosis), preventing a regular participation in the training course, pregnancy.
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
Behavioral: PRIMAS
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.
Behavioral: DTTP
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
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.
Also known as: The German Diabetes Teaching and Treatment Programme, ZI Treatment and Education Program for intensified insulin theapy
Changes in Glycemic Control Measured by A1c
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.
Time frame: Baseline and 6 months
Diabetes Knowledge
To 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.
Time frame: 6 month
Hypoglycaemia Awareness Score
The 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.
Time frame: 6 month
Diabetes Empowerment Score (DES)
Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
Time frame: 6 month follow up
Summary of Diabetes Self-Care Activities (SDSCA)
The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.
Time frame: 6 month
Diabetes Distress Scale (DDS)
Diabetes 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.
Time frame: 6 month follow up
CES-D Score
Depressive 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.
Time frame: 6 month follow up
Diabetes Self-Efficacy Scale
A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.
Time frame: 6 Month Follow up
Treatment Satisfaction / Problem Areas in Dealing With Diabetes
Satisfaction 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.
Time frame: 6 Month Follow up
Evaluation of the Diabetes Education Course
Patients 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).
Time frame: 6 month Follow up
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.
| Milestone | PRIMAS Group | Control Group |
|---|---|---|
| Started | 81 | 79 |
| Completed | 75 | 74 |
| Not completed | 6 | 5 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Attended less than 6 lessons | 1 | 2 |
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.
| Changes in A1c in percentage points | PRIMAS Group | Control Group |
|---|---|---|
| Changes in Glycemic Control Measured by A1c | -0.4 ± 1.0 | 0.0 ± 0.6 |
To 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.
Results for this outcome have not been posted.
The 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.
Results for this outcome have not been posted.
Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
Results for this outcome have not been posted.
The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.
Results for this outcome have not been posted.
Diabetes 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.
Results for this outcome have not been posted.
Depressive 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.
Results for this outcome have not been posted.
A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.
Results for this outcome have not been posted.
Satisfaction 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.
Results for this outcome have not been posted.
Patients 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).
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRIMAS Group | — | 0/81 (0%) | 0/81 (0%) |
| Control Group | — | 0/79 (0%) | 0/79 (0%) |
| Age, Categorical(Participants) | PRIMAS Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 74 | 77 | 151 |
| >=65 years | 7 | 2 | 9 |
| Age, Continuous(years) | PRIMAS Group | Control Group | Total |
|---|---|---|---|
| Mean | 45.9 ± 13.8 | 45.1 ± 13.4 | 45.5 ± 13.5 |
| Sex: Female, Male(Participants) | PRIMAS Group | Control Group | Total |
|---|---|---|---|
| Female | 31 | 39 | 70 |
| Male | 50 | 40 | 90 |
| Region of Enrollment(participants) | PRIMAS Group | Control Group | Total |
|---|---|---|---|
| Germany | 81 | 79 | 160 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Forschungsinstitut der Diabetes Akademie Mergentheim