A Novel Device for Gestational Diabetes Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 Exclusion criteria: Medications: Insulin and medications for glycemic control Antipsychotics Diuretics Corticosteroids Oncologic treatment Version 4.0 , 24/05/2022 0572-21-RMB 5 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 &gt; 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.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Device: Lumen
* Other: Glucose monitoring mobile app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be an open label parallel group 1:1 randomized-controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Lumen group<br>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<br>* 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.<br>|
| Active Comparator: The control group<br>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<br>* The control group will use a designated glucose monitoring mobile app to record their glucose levels<br>|

What is the study measuring?
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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 |