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

NCT03175315 | Completed

• 1 other identifier: NH052017
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Keywords

psychoeducation; treatment and education programme; self-management; diabetes education; flash glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Changes in Glycemic Control Measured by A1c

  Difference between baseline A1c and A1c at the 6-month follow-up

  6 months

Secondary Outcomes (10)

• Changes in "time-in-range"

  6 months

• Changes in hypoglycemic episodes

  6 months

• Changes in the duration of hypoglycemic episodes

  6 months

• Changes in hyperglycemic episodes

  6 months

• Changes in the duration of hyperglycemic episodes

  6 months

Study Arms (2)

FLASH

EXPERIMENTAL

Intervention: Conduct of the newly developed treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH). FLASH consists of 4 lessons focusing on empowering patients to autonomously use flash glucose monitoring (FGM) in their daily routine. Patients learn to effectively interpret the different information provided by FGM in order to improve not only glycemic control but also to improve the implementation of insulin therapy in daily life. Psychological and motivational aspects of living with diabetes and handling of the FGM are addressed as well.

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

Waiting List

NO INTERVENTION

Diabetic patients using FGM receive treatment as usual until the last measurement point. After completion of the study, they are offered participation in the FLASH program.

Interventions

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

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

FLASH

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensified insulin therapy / insulin pump therapy
• previous participation in a structured diabetes education program
• HbA1c ≥ 7,5% but ≤ 14%
• Reduction of HbA1c as therapeutic goal
• Indication for using FGM
• Ability to understand, speak and write German language
• informed consent (if necessary, informed consent of the parents)

You may not qualify if:

• Diabetes duration \< 1 year
• Type 2 diabetes without insulin or non-intensified insulin therapy
• severe organic disease preventing a regular participation in the training course
• pregnancy
• severe cognitive impairment
• current treatment of psychiatric disorder
• renal disease requiring dialysis

Sponsors & Collaborators

• Norbert Hermanns: lead
• Abbott Diabetes Care: collaborator

Study Sites (1)

Diabetes und Stoffwechselpraxis Wetter

Wetter, 58300, Germany

Location

Related Publications (2)

• Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. 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. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4.

  PMID: 30844467 DERIVED

• Schipfer M, Albrecht C, Ehrmann D, Haak T, Kulzer B, Hermanns N. 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 randomised controlled trial. Trials. 2018 Feb 5;19(1):91. doi: 10.1186/s13063-018-2479-9.

  PMID: 29402319 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Norbert Hermanns, PhD

  Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: June 5, 2017
• Study Start: May 2, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)