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Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring

NCT03175315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2018-08-03

No results posted yet for this study

Summary

This study is a randomized, controlled, prospective trial with a 6-month follow- up. A newly developed psychoeducational treatment and education programme for diabetic patients on an insulin therapy who use flash glucose monitoring (FGM) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are: time-in-range, frequency and duration of hypo- and hyperglycemic episodes, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes self-efficacy, self-care behavior, and hypoglycemia awareness.

Conditions

Interventions

BEHAVIORAL

Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)

Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.

Sponsors & Collaborators

  • Abbott Diabetes Care

    collaborator INDUSTRY

  • Norbert Hermanns

    lead OTHER

Principal Investigators

  • Norbert Hermanns, PhD · Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-02
Primary Completion
2018-03-09
Completion
2018-03-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03175315 on ClinicalTrials.gov