NCT01220557

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 26, 2014

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

October 12, 2010

Results QC Date

August 8, 2014

Last Update Submit

August 16, 2021

Conditions

Type 1 Diabetes

Keywords

Diabetes mellitus, education, self management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 6 months

Secondary Outcomes (9)

  • Diabetes Knowledge

    6 month

  • Hypoglycaemia Awareness Score

    6 month

  • Diabetes Empowerment Score (DES)

    6 month follow up

  • Summary of Diabetes Self-Care Activities (SDSCA)

    6 month

  • Diabetes Distress Scale (DDS)

    6 month follow up

  • +4 more secondary outcomes

Study Arms (2)

PRIMAS group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

PRIMASBEHAVIORAL

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

PRIMAS group
DTTPBEHAVIORAL

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
Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hermanns N, Kulzer B, Ehrmann D, Bergis-Jurgan N, Haak T. The effect of a diabetes education programme (PRIMAS) for people with type 1 diabetes: results of a randomized trial. Diabetes Res Clin Pract. 2013 Dec;102(3):149-57. doi: 10.1016/j.diabres.2013.10.009. Epub 2013 Oct 9.

    PMID: 24210673RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

thymidine 5'-triphosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Norbert Hermanns, PhD
Organization
Forschungsinstitut der Diabetes Akademie Mergentheim
hermanns@diabetes-zentrum.de
+49 7931 594

Study Officials

  • Norbert Hermanns, PhD

    Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 14, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 17, 2021

Results First Posted

August 26, 2014

Record last verified: 2021-08