Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628453
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
CGM for Management of Type 2 Diabetes in Pregnancy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CGM2
Brief Summary:
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose fingersticks to treat type 2 diabetes in pregnancy It will also learn about all risk factors biologic personal social for maternal and infant complications in type 2 diabetes pregnancies The main questions it aims to answer are
1 Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose
2 Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose
3 What other factors increase the risk of maternal and infant complications
Participants will
1 Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery
2 Have blood drawn at enrollment 24 weeks 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis
3 Complete surveys about social support environmental stressors diabetes distress and glucose monitoring satisfaction at research visits
4 Have umbilical cord blood collected at delivery for analysis
1 Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose
2 Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose
3 What other factors increase the risk of maternal and infant complications
Participants will
1 Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery
2 Have blood drawn at enrollment 24 weeks 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis
3 Complete surveys about social support environmental stressors diabetes distress and glucose monitoring satisfaction at research visits
4 Have umbilical cord blood collected at delivery for analysis
Detailed Description:
We will conduct a multicenter open-label randomized controlled trial of pregnant individuals with T2DM to test the effectiveness of CGM at improving maternal and neonatal outcomes compared to SMBG All pregnant women who have T2DM will be screened for eligibility If a patient is eligible the study will be explained to them and if they consent to participate they will be randomized centrally in a 11 ratio to CGM or SMBG
Participants randomized to CGM will receive a Dexcom G7 CGM and be instructed how to apply it access the CGM data and how to interpret and respond to trend arrows and alerts Participants will replace the CGM device with a new sensor every 10 days for the entire pregnancy Participants randomized to SMBG will be instructed to perform SMBG at least 4 times daily fasting and 1-hour or 2-hours postprandial and share their glucose data with their provider according to standard care In order to collect comparable assessments of glycemic control between the groups participants randomized to SMBG will wear a masked CGM for 10 days after randomization Visit 1 and after Visits 2 24 weeks and Visit 3 34 weeks All participants will be provided a glucometer if they do not already have one and will have HbA1c and maternal serum collected at enrollment 6-22 weeks and all study visits 24 weeks 34 weeks and delivery
We will utilize ACOG and ADA recommendations for glycemic targets in pregnancy a standardized protocol with graduated goals for glycemic control to ensure consistency across arms and study sites For pregnant individuals randomized to CGM the target range will be 63-140mgdL For pregnant individuals randomized to SMBG the targets will be fasting lt95mgdL 1-hour postprandial less than 140mgdL and 2-hour postprandial less than 120mgdL CGM reports and glucose logs will be reviewed at least every 1-2 weeks and therapy adjustments insulin metformin diet andor lifestyle will be recommended if less than 70 of glucose values are at target regardless of the method of glucose monitoring Additional therapy adjustments will be encouraged to achieve greater than 70 glucose values at target so long as there is not significant hypoglycemia ie greater than 4
Telehealth visits may be utilized in addition to outpatient in person visits at the discretion of the provider but should be used similarly for the CGM and SMBG groups This protocol for glycemic management will be followed at all times including both at outpatient visits and during inpatient antepartum hospitalization Intrapartum glycemic control fetal testing and timing and route of delivery will be determined by the clinical provider in accordance with ACOG recommendations After birth umbilical cord blood will be collected for metabolic analyses and neonates will have a heelstick performed to measure capillary blood glucose as part of usual care given maternal T2DM Additional care including NICU admission and treatment of hypoglycemia will be at the discretion of the neonatal provider
Validated screening tools to assess different SDoH domains will be administered at the first 2 study visits At enrollment each participant will be administered the Protocol for Responding to and Assessing Patient Assets Risks and Experiences PRAPARE survey a validated screening tool designed to identify SDoH including personal factors family and housing money and resources and social and emotional health and safety The home address provided will be used to calculate SVI and area deprivation index ADI a measure created to assess socioeconomic disadvantage at a neighborhood level based on income education employment and housing quality Participants will complete the US Adult Household Food Security Survey Module HFSSM a 10-item self-report questionnaire aimed at assessing food security over the prior 12 months as food insecurity may be associated with adverse outcomes Participants will also complete the Type 2 Diabetes Distress Assessment System T2-DDAS a 29-item survey designed to identify the overall amount of DM-related distress as well as the sources of stress including hypoglycemia long-term health healthcare provider interpersonal issues shame or stigma healthcare access and management demands At visit 2 participants will complete the Short Assessment of Health Literacy SAHL and the Diabetes Numeracy Test 15 DNT15 given association between lower educational attainment and health literacy and numeracy with worse outcomes Participants will also complete the Multidimensional Scale of Perceived Social Support MSPSS the only self-reported measure in a study of psychosocial stress associated with adverse pregnancy outcomes and the Experiences of Discrimination EOD scale a 9-item self-report about lifetime experiences of discrimination attributed to race ethnicity or skin color At delivery participants will repeat the T2-DDAS to assess if CGM impacted DM distress and complete a Glucose Monitoring Satisfaction Survey GMSS a validated tool to assess satisfaction with the assigned method of glucose monitoring
Participants randomized to CGM will receive a Dexcom G7 CGM and be instructed how to apply it access the CGM data and how to interpret and respond to trend arrows and alerts Participants will replace the CGM device with a new sensor every 10 days for the entire pregnancy Participants randomized to SMBG will be instructed to perform SMBG at least 4 times daily fasting and 1-hour or 2-hours postprandial and share their glucose data with their provider according to standard care In order to collect comparable assessments of glycemic control between the groups participants randomized to SMBG will wear a masked CGM for 10 days after randomization Visit 1 and after Visits 2 24 weeks and Visit 3 34 weeks All participants will be provided a glucometer if they do not already have one and will have HbA1c and maternal serum collected at enrollment 6-22 weeks and all study visits 24 weeks 34 weeks and delivery
We will utilize ACOG and ADA recommendations for glycemic targets in pregnancy a standardized protocol with graduated goals for glycemic control to ensure consistency across arms and study sites For pregnant individuals randomized to CGM the target range will be 63-140mgdL For pregnant individuals randomized to SMBG the targets will be fasting lt95mgdL 1-hour postprandial less than 140mgdL and 2-hour postprandial less than 120mgdL CGM reports and glucose logs will be reviewed at least every 1-2 weeks and therapy adjustments insulin metformin diet andor lifestyle will be recommended if less than 70 of glucose values are at target regardless of the method of glucose monitoring Additional therapy adjustments will be encouraged to achieve greater than 70 glucose values at target so long as there is not significant hypoglycemia ie greater than 4
Telehealth visits may be utilized in addition to outpatient in person visits at the discretion of the provider but should be used similarly for the CGM and SMBG groups This protocol for glycemic management will be followed at all times including both at outpatient visits and during inpatient antepartum hospitalization Intrapartum glycemic control fetal testing and timing and route of delivery will be determined by the clinical provider in accordance with ACOG recommendations After birth umbilical cord blood will be collected for metabolic analyses and neonates will have a heelstick performed to measure capillary blood glucose as part of usual care given maternal T2DM Additional care including NICU admission and treatment of hypoglycemia will be at the discretion of the neonatal provider
Validated screening tools to assess different SDoH domains will be administered at the first 2 study visits At enrollment each participant will be administered the Protocol for Responding to and Assessing Patient Assets Risks and Experiences PRAPARE survey a validated screening tool designed to identify SDoH including personal factors family and housing money and resources and social and emotional health and safety The home address provided will be used to calculate SVI and area deprivation index ADI a measure created to assess socioeconomic disadvantage at a neighborhood level based on income education employment and housing quality Participants will complete the US Adult Household Food Security Survey Module HFSSM a 10-item self-report questionnaire aimed at assessing food security over the prior 12 months as food insecurity may be associated with adverse outcomes Participants will also complete the Type 2 Diabetes Distress Assessment System T2-DDAS a 29-item survey designed to identify the overall amount of DM-related distress as well as the sources of stress including hypoglycemia long-term health healthcare provider interpersonal issues shame or stigma healthcare access and management demands At visit 2 participants will complete the Short Assessment of Health Literacy SAHL and the Diabetes Numeracy Test 15 DNT15 given association between lower educational attainment and health literacy and numeracy with worse outcomes Participants will also complete the Multidimensional Scale of Perceived Social Support MSPSS the only self-reported measure in a study of psychosocial stress associated with adverse pregnancy outcomes and the Experiences of Discrimination EOD scale a 9-item self-report about lifetime experiences of discrimination attributed to race ethnicity or skin color At delivery participants will repeat the T2-DDAS to assess if CGM impacted DM distress and complete a Glucose Monitoring Satisfaction Survey GMSS a validated tool to assess satisfaction with the assigned method of glucose monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None