N/A
Completed N=160
Evaluation of a Treatment and Education Programme for Type 1 Diabetic Patients (PRIMAS)
Source: ClinicalTrials.gov NCT01220557 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Changes in Glycemic Control Measured by A1c — -0.4; 0.0 Changes in A1c in percentage points
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Glycemic Control Measured by A1c |
-0.4; 0.0 | — |
| SECONDARY Diabetes Knowledge |
— | — |
| SECONDARY Hypoglycaemia Awareness Score |
— | — |
| SECONDARY Diabetes Empowerment Score (DES) |
— | — |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA) |
— | — |
| SECONDARY Diabetes Distress Scale (DDS) |
— | — |
| SECONDARY CES-D Score |
— | — |
| SECONDARY Diabetes Self-Efficacy Scale |
— | — |
| SECONDARY Treatment Satisfaction / Problem Areas in Dealing With Diabetes |
— | — |
| SECONDARY Evaluation of the Diabetes Education Course |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01220557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.