Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of FGM

NCT ID: NCT05924724

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-12-31

Brief Summary

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).

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.

Conditions

Gestational Diabetes; Gestational Diabetes Mellitus in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Flash Glucose Monitoring

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Friederike Weschenfelder, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Jena, Department of Obstetrics

Locations

Universitätsklinikum Jena

Jena, Thuringia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Yvonne Heimann, M. Sc.

Role: CONTACT

yvonne.heimann@med.uni-jena.de

+49 3641 9 390 868

Facility Contacts

Friederike Weschenfelder, Dr. med.

Role: primary

friederike.weschenfelder@med.uni-jena.de

03641 9 329284

Yvonne Heimann, M. Sc.

Role: backup

yvonne.heimann@med.uni-jena.de

03641 9 390868

Other Identifiers

Flash

Identifier Type: -

Identifier Source: org_study_id