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

Primary Purpose

Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Flash Glucose Monitoring
Sponsored by
Jena University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gestational Diabetes focused on measuring Gestational Diabetes, GDM, FGM, Flash Glucose Monitoring, SMBG, self monitoring of blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum JenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Usage Flash-Glucose Monitoring FGM

Usage Self-Monitoring Blood Glucose SMBG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment Satisfaction
The treatment satisfaction is anticipated to be evaluated using the Diabetes Treatment Satisfaction Questionnaire

Secondary Outcome Measures

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.
Activity in the last 7 days
The activity is evaluated using the international physical activity questionnaire IPAQ.

Full Information

First Posted
June 21, 2023
Last Updated
June 21, 2023
Sponsor
Jena University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05924724
Brief Title
Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of FGM
Acronym
Flash
Official Title
Prospective, Randomized Pilot Study to Improve the Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of Flash Glucose Monitoring Systems
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jena University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. We 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy
Keywords
Gestational Diabetes, GDM, FGM, Flash Glucose Monitoring, SMBG, self monitoring of blood glucose

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usage Flash-Glucose Monitoring FGM
Arm Type
Experimental
Arm Description
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.
Arm Title
Usage Self-Monitoring Blood Glucose SMBG
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Flash Glucose Monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Satisfaction
Description
The treatment satisfaction is anticipated to be evaluated using the Diabetes Treatment Satisfaction Questionnaire
Time Frame
The questionnaire will be filled by the participant during 33 to 35 weeks of gestation.
Secondary Outcome Measure Information:
Title
Step Count per Day
Description
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.
Time Frame
daily starting at 24 weeks of gestation until delivery
Title
Activity in the last 7 days
Description
The activity is evaluated using the international physical activity questionnaire IPAQ.
Time Frame
every two weeks starting at 24 weeks of gestation until delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Heimann, M. Sc.
Phone
+49 3641 9 390 868
Email
yvonne.heimann@med.uni-jena.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friederike Weschenfelder, Dr.
Organizational Affiliation
University Hospital Jena, Department of Obstetrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Friederike Weschenfelder, Dr. med.
Phone
03641 9 329284
Email
friederike.weschenfelder@med.uni-jena.de
First Name & Middle Initial & Last Name & Degree
Yvonne Heimann, M. Sc.
Phone
03641 9 390868
Email
yvonne.heimann@med.uni-jena.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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