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NCT03175315: FLASH

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

Completed NA Last updated 3 August 2018
What this trial tests

NA trial testing Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH) in Diabetes Mellitus in 216 participants. Completed in 9 March 2018.

Timeline
2 May 2017
Primary endpoint
9 March 2018
9 March 2018

Quick facts

Lead sponsorNorbert Hermanns
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment216
Start date2 May 2017
Primary completion9 March 2018
Estimated completion9 March 2018
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Norbert Hermanns

Who can join

Adults 16 to 75, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial.
    Hermanns N, Ehrmann D, Schipfer M, Kröger J, et al · · 2019 · cited 66× · PMID 30844467 · DOI 10.1016/j.diabres.2019.03.003
  2. Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a rand
    Schipfer M, Albrecht C, Ehrmann D, Haak T, et al · · 2018 · cited 1× · PMID 29402319 · DOI 10.1186/s13063-018-2479-9

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Other recruiting trials for Diabetes Mellitus

Currently open trials in the same condition.

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Data sources for this page

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