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

NCT05924724 | Unknown

• 1 other identifier: Flash
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes; Gestational Diabetes Mellitus in Pregnancy

Keywords

Gestational Diabetes; GDM; FGM; Flash Glucose Monitoring; SMBG; self monitoring of blood glucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Step Count per Day

  daily starting at 24 weeks of gestation until delivery

• Activity in the last 7 days

  every two weeks starting at 24 weeks of gestation until delivery

Study Arms (2)

Usage Flash-Glucose Monitoring FGM

EXPERIMENTAL

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

Usage Self-Monitoring Blood Glucose SMBG

NO INTERVENTION

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.

Interventions

Flash Glucose Monitoring 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 Flash-Glucose Monitoring FGM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (1)

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Friederike Weschenfelder, Dr.

  University Hospital Jena, Department of Obstetrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvonne Heimann, M. Sc.

CONTACT

+49 3641 9 390 868; yvonne.heimann@med.uni-jena.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled trial

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)