Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of FGM (Flash)

Prospective, Randomized Pilot Study to Improve the Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of Flash Glucose Monitoring Systems

The incidence of gestational diabetes mellitus (GDM), a glucose tolerance disorder during pregnancy, is increasing. In Germany, it reached 8.58 % in 2019. Standardized treatment has reduced complications for mother and child. Blood self-measurement is currently used to monitor glucose levels, but it is burdensome and disliked by patients. Flash Glucose Monitoring (FGM) was approved in 2017, but its routine use lacks sufficient data. This pilot project aims to study the impact of FGM on patient satisfaction and adherence to therapy. The hypothesis is that FGM will improve patient experience and increase therapy adherence. The study will include 100 GDM-diagnosed women who will be randomly assigned to FGM or SMBG treatment. The primary endpoint is treatment satisfaction and adherence, measured through step count, physical activity, food error count, and weight gain. The project aims to provide data for patient-centered decision-making on glucose monitoring systems, following the principles of the Association of Diabetes Counseling and Training Professions in Germany (VDBD).

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes; Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Device: Flash Glucose Monitoring

Detailed Description

The incidence of gestational diabetes mellitus (GDM), defined as a glucose tolerance disorder diagnosed for the first time during pregnancy, is steadily increasing, reaching 8.58 % in Germany in 2019, according to figures from the Institute for Quality Assurance and Transparency in Health Care (IQTIG). Standardized guideline-compliant treatment has significantly reduced the rate of perinatal complications for both mother and child. A central component of management is the adjustment of blood glucose levels to the specified target values. To date, patients' glucose levels have been determined by blood self-measurement (SMBG) in accordance with guidelines. The diagnosis of GDM and the subsequent management is perceived by the patients as an enormous burden, especially because of the self-measurement, which is perceived as time-consuming, painful and stigmatizing. Since 2017, the Flash Glucose Monitoring (FGM) has been approved for use in the care of pregnant diabetic women. Its use by gestational diabetics is critically discussed. To date, there is a lack of systematically collected data on the use of FGM in the care of GDM patients that would justify its routine use.

The aim of the pilot project planned here is to investigate the influence of FGM on patient satisfaction and adherence to therapy. The investigators hypothesize that the use of the FGM relieves the affected women decisively and mediated by biofeedback leads to more therapy adherence. These data will be used to plan a multicenter study.

At the Competence Center for Diabetes and Pregnancy of the University Hospital Jena, 100 women diagnosed with GDM will be included in a randomized controlled trial and will be treated with either FGM (n = 50) or SMBG (n = 50) and followed up according to the guidelines.

The primary endpoint is the assessment of treatment satisfaction and adherence using the following measures: step count, physical activity (IPAQ), food error count and weight gain.

In order to meet the principle "In the sense of a patient-centered individual therapy, the affected persons should be involved in the decision for or against a glucose monitoring system" of the Association of Diabetes Counseling and Training Professions in Germany (VDBD), the aim of our project is to create a data basis for this.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yvonne Heimann, M. Sc.; Phone Number: +49 3641 9 390 868; Email: yvonne.heimann@med.uni-jena.de

Study Locations

• Germany
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Recruiting
      • Universitätsklinikum Jena
      • Contact: Friederike Weschenfelder, Dr. med.; Phone Number: 03641 9 329284; Email: friederike.weschenfelder@med.uni-jena.de
      • Contact: Yvonne Heimann, M. Sc.; Phone Number: 03641 9 390868; Email: yvonne.heimann@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• written informed consent
• age above 18 years
• single cephalic pregnancy
• newly diagnosed gestational diabetes mellitus
• 24+0 - 30+0 weeks of gestation

Exclusion Criteria:

• severe pregnancy complications
• severe fetal malformations
• rejection of FGM device by health care provider
• existing diabetes mellitus (type 1 or type 2)
• glucose metabolism affecting diseases
• bariatric surgeries in the past

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usage Flash-Glucose Monitoring FGM; Participants in this arm will transition from routine care using SMBG to using FGM after one week. They will receive training on how to use the FGM device. The FGM will be used continuously from that point until delivery, throughout the entire pregnancy.	Device: Flash Glucose Monitoring; The FGM is a non-invasive device typically worn on the upper arm, designed to continuously measure blood glucose levels without the need for fingerstick capillary measurements.
No Intervention: Usage Self-Monitoring Blood Glucose SMBG; Participants in this arm will remain in the routine care using SMBG. They will use it continuously from diagnosis until delivery, throughout the entire pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction	The treatment satisfaction is anticipated to be evaluated using the Diabetes Treatment Satisfaction Questionnaire change (DTSQc) with minimal value of -18 and maximal value of 18, with higher values indicating more satisfaction.	The questionnaire will be filled by the participant during 33 to 35 weeks of gestation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Count per Day	Step count will be documented by the participant and will be evaluated as progression. It is advised, that patients diagnosed with diabetes aim to increase their step count.	daily starting at 24 weeks of gestation until delivery
Activity in the last 7 days	The activity is evaluated using the international physical activity questionnaire (IPAQ). The Score provides the metabolic equivalent of task (MET)-minutes per week in total, with a minimum of 0 and a maximum of 100.000 MET-min/week. Higher score indicate higher activity.	every two weeks starting at 24 weeks of gestation until delivery

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Friederike Weschenfelder, Dr., University Hospital Jena, Department of Obstetrics

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: SMBG; GDM; Gestational Diabetes; self monitoring of blood glucose; Flash Glucose Monitoring; FGM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: Flash

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No