Type 1 Diabetes
Conditions
Keywords
Diabetes mellitus, education, self management
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPRIMAS
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
BEHAVIORALDTTP
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.
Sponsors
Forschungsinstitut der Diabetes Akademie Mergentheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glycemic Control Measured by A1c | Baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycaemia Awareness Score | 6 month | 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. |
| Diabetes Empowerment Score (DES) | 6 month follow up | Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy. |
| Summary of Diabetes Self-Care Activities (SDSCA) | 6 month | 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. |
| Diabetes Distress Scale (DDS) | 6 month follow up | 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. |
| Diabetes Knowledge | 6 month | 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. |
| Diabetes Self-Efficacy Scale | 6 Month Follow up | A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy. |
| Treatment Satisfaction / Problem Areas in Dealing With Diabetes | 6 Month Follow up | 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. |
| Evaluation of the Diabetes Education Course | 6 month Follow up | 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). |
| CES-D Score | 6 month follow up | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 81 |
| 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. | 79 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | attended less than 6 lessons | 1 | 2 |
| Overall Study | Lost to Follow-up | 5 | 3 |
Baseline characteristics
| Characteristic | Control Group | PRIMAS Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 7 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 74 Participants | 151 Participants |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 13.4 | 45.9 years STANDARD_DEVIATION 13.8 | 45.5 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment Germany | 79 participants | 81 participants | 160 participants |
| Sex: Female, Male Female | 39 Participants | 31 Participants | 70 Participants |
| Sex: Female, Male Male | 40 Participants | 50 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 81 | 0 / 79 |
| serious Total, serious adverse events | 0 / 81 | 0 / 79 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRIMAS Group | Changes in Glycemic Control Measured by A1c | -0.4 Changes in A1c in percentage points | Standard Deviation 1 |
| Control Group | Changes in Glycemic Control Measured by A1c | 0.0 Changes in A1c in percentage points | Standard Deviation 0.6 |
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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