Improving treatment satisfaction for diabetic women using Flash Glucose Monitoring
Prospective, Randomized Pilot Study to Improve the Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of Flash Glucose Monitoring Systems
NA · Jena University Hospital · NCT05924724
This study is testing if using Flash Glucose Monitoring can help women with gestational diabetes feel more satisfied with their treatment compared to traditional blood sugar checks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jena University Hospital (other) |
| Locations | 1 site (Jena, Thüringen) |
| Trial ID | NCT05924724 on ClinicalTrials.gov |
What this trial studies
This pilot project investigates the impact of Flash Glucose Monitoring (FGM) on treatment satisfaction and adherence among women diagnosed with gestational diabetes mellitus (GDM). The study will randomly assign 100 participants to either FGM or traditional self-measurement of blood glucose (SMBG) to assess differences in patient experience and adherence to therapy. Primary endpoints include treatment satisfaction, physical activity levels, food error counts, and weight gain. The goal is to provide data that supports patient-centered decision-making regarding glucose monitoring systems during pregnancy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older, newly diagnosed with gestational diabetes between 24 and 30 weeks of pregnancy.
Not a fit: Patients with severe pregnancy complications, existing diabetes, or those who have undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the treatment experience and adherence to therapy for women with gestational diabetes.
How similar studies have performed: While the use of Flash Glucose Monitoring has been approved, systematic data on its effectiveness in gestational diabetes care is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jena, Thüringen
- Universitätsklinikum Jena — Jena, Thüringen, Germany (RECRUITING)
Study contacts
- Principal investigator: Friederike Weschenfelder, Dr. — University Hospital Jena, Department of Obstetrics
- Study coordinator: Yvonne Heimann, M. Sc.
- Email: yvonne.heimann@med.uni-jena.de
- Phone: +49 3641 9 390 868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, GDM, FGM, Flash Glucose Monitoring, SMBG, self monitoring of blood glucose