A Novel Device for Gestational Diabetes Control

A Novel Device for Gestational Diabetes Control, a Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Device: Lumen; Other: Glucose monitoring mobile app

Detailed Description

Objective The aim of the study is to examine the effect of using Lumen on metabolic parameters and anthropometric variables in patients with gestational diabetes mellitus. Aims and hypotheses Primary aim: To evaluate the rate of progression from GDM-A1 to GDM-A2 between the groups.

Secondary aim: To evaluate the efficacy of Lumen on metabolic parameters, obstetric outcomes, and neonatal outcomes. Hypothesis: the investigators expect that using Lumen would reduce the rate of progression from GDM-A1 to GDM- A2. Methods Design This will be an open label parallel group 1:1 randomized-controlled trial. Participants The study will include up to 170 women diagnosed with GDM. GDM will be defined according to current ACOG (The American College of Obstetricians and Gynecologists) guidelines. A positive glucose challenge test at 24-28 weeks' gestation followed by at least two pathological values in oral glucose challenge or one pathological value and at least one additional risk factor for GDM (a first family member diagnosed with type 2 DM, obesity, history of GDM).

Women in both groups it will use a glucometer and will be instructed in the use of the device. Use will include puncture of the fingertip to obtain a drop of blood and use of a suitable probe to obtain a sugar measurement.

Eligibility criteria

Inclusion criteria:

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

Exclusion criteria:

Medications:

1. Insulin and medications for glycemic control
2. Antipsychotics
3. Diuretics
4. Corticosteroids
5. Oncologic treatment

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Conditions:

1. Previous diagnosis of diabetes
2. Renal disease
3. Hepatic disease

Personal requirements:

1. Inability to read and understand English
2. Inability to use a smartphone
3. Any issues arise with using the Lumen device and application
4. Aerobic exercise > 3 times per week Recruitment Women with GDM will be recruited via clinical referrals from the feto-maternal outpatient clinic or the feto-maternal unit in Rambam medical center (RMC) Intervention All the participants will be under regular follow-up of the treating obstetrician in the feto-maternal outpatient clinic. After the diagnosis of GDM the patients (of both groups) will be instructed regarding recommended diet and glucose monitoring as accustomed in our department. After randomization to the lumen group, 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 control group will use the glucose buddy app and will be managed in accordance with the common guidelines for GDM management. Participants of both group will measure their fating blood glucose levels and their postprandial blood glucose levels and record it in their mobile app.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naphtali Justman, MD; Phone Number: 0546836644; Email: njustman88@gmail.com
• Study Contact Backup: Name: Maram Bashara; Phone Number: 0544395312; Email: m_bashara@rmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Medications:

1. Insulin and medications for glycemic control
2. Antipsychotics
3. Diuretics
4. Corticosteroids
5. Oncologic treatment

Conditions:

1. Previous diagnosis of diabetes
2. Renal disease
3. Hepatic disease

Personal requirements:

1. Inability to read and understand English
2. Inability to use a smartphone
3. Any issues arise with using the Lumen device and application
4. Aerobic exercise > 3 times per week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Lumen group; 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; 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.
Active Comparator: The control group; 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; The control group will use a designated glucose monitoring mobile app to record their glucose levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
to compare the maternal age	maternal age in years	From date of randomization until the date delivery, assessed up to 4 months
to compare the gestational age at delivery	gestational age at delivery in weeks	From date of randomization until the date delivery, assessed up to 4 months
to compare the parity between the groups	parity	From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of family history of DM	family history of DM	From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of chronic hypertension	reported chronic hypertension	From date of randomization until the date delivery, assessed up to 4 months
to compare smoking status	smoking status in medical records	From date of randomization until the date delivery, assessed up to 4 months
to compare baseline fertility characteristics	Need for assisted reproductive technology	From date of randomization until the date delivery, assessed up to 4 months
to compare baseline metabolic parameters	fasting glucose obtained at first trimester, values of glucose challenge test (GCT) and oral glucose tolerance test (OGTT), hemoglobin A1C (HbA1C) upon diagnosis	From date of randomization until the date delivery, assessed up to 4 months
to compare baseline educational status	years of education	From date of randomization until the date delivery, assessed up to 4 months
to compare the level of physical activity	level of physical activity as reported by the patients	at the date of randomization
to compare baseline body mass index between the groups	patient's body mass index (BMI)	at the date of randomization
To compare the Gestational age at delivery	Gestational age at delivery in weeks	at the date if delivery
to compare the mode of onset of labor	mode of onset of labor (medical or surgical)	at the date if delivery
to compare the rate of of preeclampsia or gestational hypertension	the presence of preeclampsia or gestational hypertension	From date of randomization until the date delivery, assessed up to 4 months
to compare the rate of polyhydramnios	polyhydramnios (amniotic fluid index > 95th percentile for gestational age)	From date of randomization until the date delivery, assessed up to 4 months
To compare the rate of antenatal corticosteroids administration	Antenatal corticosteroids administration	From date of randomization until the date delivery, assessed up to 4 months
To evaluate the efficacy of Lumen on mode of delivery	mode of delivery	At the date of delivery
To evaluate the efficacy of Lumen on shoulder dystocia rate	shoulder dystocia as reported in medical records	At the date of delivery
To compare the rate of episiotomy	the use of episiotomy	At the date of delivery
To evaluate the change it the rate of obstetric anal sphincter injuries	Rate of obstetric anal sphincter injuries	At the date of delivery
To evaluate the change in birthweight	Birth weight in grams	At the date of delivery
To evaluate the change in neonatal death rate	neonatal death rate	from the date of delivery and up to 1 month from delivery
To evaluate the change in neonatal length of stay	neonatal length of stay in days	from the date of delivery and up to 1 month from delivery
To evaluate the change in hypoglycemia of the newborn	hypoglycemia of the newborn is defined as blood glucose levels below 40	from the date of delivery and up to 1 month from delivery
To evaluate the change in respiratory morbidity	respiratory morbidity	from the date of delivery and up to 1 month from delivery
To evaluate the change in need for phototherapy	Need for phototherapy	from the date of delivery and up to 1 month from delivery
To evaluate the change in need for neonatal intensive care unit (NICU) admission	neonatal intensive care unit (NICU) admission	from the date of delivery and up to 1 month from delivery

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 0572-21-RMB CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No