Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812547
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2022-11-22
Brief Title:
A Novel Device for Gestational Diabetes Control
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
A Novel Device for Gestational Diabetes Control a Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 11 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 167 decrease in insulin use to balance diabetes with α 005 and β 80
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 11 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
Version 40 24052022 0572-21-RMB
5
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 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
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 11 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
Version 40 24052022 0572-21-RMB
5
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None