A Novel Device for Gestational Diabetes Control

NCT05812547 | Not Yet Recruiting

• 1 other identifier: 0572-21-RMB CTIL
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale of the study: Gestational diabetes mellitus (GDM) is very common and the rate of women suffering from it expected to increase in the next years. It is associated with maternal and fetal morbidity and the risk is correlated to the patient's degree of glucose control which can be achieved through a change in lifestyle or medication. Several studies have demonstrated the effectiveness of mobile apps in improving obstetric outcomes in GDM. In addition, the LUMEN device is a breathing device that produces dietary and exercise recommendations based on CO2 levels and improves metabolic parameters in patients with type 2 diabetes. No work has been done on its effectiveness in treating GDM. Aims of the study: Comparison of metabolic outcomes in women with gestational diabetes, with or without the use of LUMEN app. Design: This will be an open label parallel group 1:1 randomized-controlled trial Methods: the investigators will recruit women diagnosed with GDM. The women will be randomized to the intervention arm that will use the LUMEN device and app or to the control arm that will use a free mobile tracking app. The women will be required to monitor their blood sugar levels daily and to have GDM follow-up in the feto-maternal outpatient clinic, as is customary in GDM. After the birth, the maternal and neonatal outcome will be recorded. Based on past research data, a recruitment of 170 is needed to demonstrate a 16.7% decrease in insulin use to balance diabetes, with α = 0.05 and β = 80.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• To evaluate the average change in blood glucose levels with the use the Lumen device

  The blood glucose levels will be recorded and the average levels will be compared between the groups

  From date of randomization until the date delivery, assessed up to 4 months

Secondary Outcomes (27)

• to compare the maternal age

  From date of randomization until the date delivery, assessed up to 4 months

• to compare the gestational age at delivery

  From date of randomization until the date delivery, assessed up to 4 months

• to compare the parity between the groups

  From date of randomization until the date delivery, assessed up to 4 months

• to compare the rate of family history of DM

  From date of randomization until the date delivery, assessed up to 4 months

• to compare the rate of chronic hypertension

  From date of randomization until the date delivery, assessed up to 4 months

Study Arms (2)

The Lumen group

EXPERIMENTAL

subjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection

Device: Lumen

The control group

ACTIVE COMPARATOR

The control group will use a mobile app to keep track of their glucose levels and will be managed in accordance with the common guidelines for GDM management. Participants of both groups will measure their fasting blood glucose levels and their postprandial blood glucose levels and record it in their mobile app

Other: Glucose monitoring mobile app

Interventions

Lumen DEVICE

subjects will use the Lumen device and mobile phone application, which will guide them once a day after the night fast regarding their daily diet, sleep, and routines according to their Lumen measurements. Subjects will need Google Fit (Android) or Apple Health Kit (iOS) and will be encouraged to communicate with a study investigator via the app during the entirety of the study to resolve technical questions about the device and data collection.

The Lumen group

Glucose monitoring mobile app OTHER

The control group will use a designated glucose monitoring mobile app to record their glucose levels

The control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gravidas aged 18-45 years
• Singleton pregnancy
• Diagnosed with GDM in current pregnancy
• First visit to high-risk pregnancy clinic is no late than 32 weeks' gestation
• Not treated with diabetes-related medications

You may not qualify if:

• Medications:
• Insulin and medications for glycemic control
• Antipsychotics
• Diuretics
• Corticosteroids
• Oncologic treatment
• Conditions:
• Previous diagnosis of diabetes
• Renal disease
• Hepatic disease
• Personal requirements:
• Inability to read and understand English
• Inability to use a smartphone
• Any issues arise with using the Lumen device and application
• Aerobic exercise \> 3 times per week

Sponsors & Collaborators

• Rambam Health Care Campus: lead

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

Central Study Contacts

Naphtali Justman, MD

CONTACT

0546836644; njustman88@gmail.com

Maram Bashara

CONTACT

0544395312; m_bashara@rmc.gov.il

Study Design

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

Model Details: This will be an open label parallel group 1:1 randomized-controlled trial.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: April 13, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06