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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 3/18/2024 | Other Identifier | Unity Point Health - Meriter | |
| A532860 | Other Identifier | UW Madison | |
| 2022-0459 | Other Identifier | UW-Madison IRB | |
| 2022-028 | Other Identifier | Unity Point Health - Meriter |
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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).
This pilot single site randomized control trial will compare the blood glucose control and participant satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant women with a prior diagnosis of Type 2 diabetes.
The study population will consist of 40 women who are less than 20 weeks pregnant at time of enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes. Participants will be randomized to one of two treatment arms.
Participant accrual will occur over 18 months at 1 site. Participants will complete 3 study visits, all of which will be in conjunction with previously scheduled prenatal or diabetes visits: at the time of consent (less than 20 weeks gestation), 28-32 weeks gestation, and 2-6 weeks postpartum.. Surveys will be administered at each time point. At the final visit, patients will be asked for participate in a 2-5 minute directed interview as well.
Primary Objective
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Continuous Glucose Monitor (CGM) | Experimental | CGM for duration of pregnancy. |
|
| Arm 2: Point of Care Glucose Testing (POCT) | Active Comparator | Point of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 CGM | Device | Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data. Experimental Group will wear CGM for the duration of their pregnancy. Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period | Completion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is. | up to 24 months |
| Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management | Individualized postpartum interviews and qualitative surveys administered at each time point will be used to gather information about participants thoughts and experiences in both arms of the trial about their ability to manage diabetes in pregnancy. Interviews will be analyzed for theme and content. Higher numbers indicate higher satisfaction with diabetes management. | baseline, 12 weeks on study, and postpartum (up to 26 weeks on study) |
| Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range | The primary endpoint is the total time within range (blood glucose level 70-140 mg/dL). All CGM data will be extracted from the Dexcom server for analysis. This measure is used to determine if time in range (TIR) is a suitable clinical endpoint for a larger trial. TIR for both arms will be determined and 95% confidence intervals around the difference in means calculated. TIR will be considered suitable if the upper 95% confidence interval for the difference in means is greater than 5 units in favor of CGM. | Baseline, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cesarean Delivery | approximately 20 weeks on study (at time of delivery) | |
| Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester | baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacquelyn H Adams, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53715 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Continuous Glucose Monitor (CGM) | CGM for duration of pregnancy. |
| FG001 | Arm 2: Point of Care Glucose Testing (POCT) | Point of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Continuous Glucose Monitor (CGM) | CGM for duration of pregnancy. |
| BG001 | Arm 2: Point of Care Glucose Testing (POCT) | Point of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period | Completion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is. | Posted | Count of Participants | Participants | up to 24 months |
|
Up to 26 weeks on study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Continuous Glucose Monitor (CGM) | CGM for duration of pregnancy. Dexcom G6 CGM: Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data. Experimental Group will wear CGM for the duration of their pregnancy. Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UW Ob/Gyn Human Subjects Core | UW Madison | 608-890-3345 | research.crc_obgyn@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2024 | Oct 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011254 | Pregnancy in Diabetics |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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pilot, prospective, randomized trial
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Participant will know what arm they are randomized to, participants and physicians in Arm 2 will be blinded to CGM data collected for 10 days at 2 timepoints.
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|
| Participant Finger Stick Glucose Monitoring | Other | Standard of care for individual participant |
|
|
| Percentage of Time Spent in Hyperglycemic Range | Hyperglycemic range is considered greater than 140 mg/dL. A very high hyperglycemic range is >250mg/dL. | up to 26 weeks |
| Percentage of Time Spent in Hypoglycemic Range | Hypoglycemic range is considered less than 70 mg/dL. Low is 55-70, very low is <54. | 26 weeks |
| Rates of Gestational Hypertension | Gestational hypertension is defined as systolic blood pressure 140 mm Hg or diastolic blood pressure 90 mg Hg on two occasions at least 4 hours apart. | up to approximately 20 weeks on study |
| Rates of Preeclampsia | Gestational hypertension plus either new-onset proteinuria [300 mg/24 hours, protein:creatinine 0.3 mg/dL], thrombocytopenia [platelet count<100,000/uL], elevated Aspartate transaminase or alanine transaminase [>2 upper limit of normal], renal insufficiency [serum creatinine>1.1 mg/dL or an unexplained doubling of creatinine], pulmonary edema, or cerebral or visual symptoms. | up to approximately 20 weeks on study |
| Rates of Polyhydramnios | up to approximately 20 weeks on study |
| Incidence of Neonatal Hypoglycemia | up to 26 weeks |
| Rates of Fetal Macrosomia | Actual birthweight greater than 95 percent by Fenton growth curve for newborns | up to 26 weeks |
| Rates of NICU Admission | up to 26 weeks |
| Rates of Spontaneous Preterm Delivery | Preterm delivery is considered less than 37 weeks. | up to approximately 17 weeks on study (less than 37 weeks gestation) |
| Satisfaction and Quality of Life Survey Scores (5-point Likert Scale) | Satisfaction and Quality of Life survey will be administered and answers will be compared between groups. Survey questions include answers on a 5-point Likert scale. Scores range from 15-75, where higher scores indicate lower satisfaction and quality of life, and lower scores indicate higher satisfaction and quality of life. | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
| Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings | The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity. | 2-4 weeks postpartum (up to 26 weeks on study) |
| Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring | Explore if traditional management versus continuous glucose management has higher feelings of control over diabetes management. The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity. | 2-4 weeks postpartum (up to 26 weeks on study) |
| Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
| Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
| Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
| Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
| Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | Participants |
|
| Private insurance status | Count of Participants | Participants |
|
| Most recent A1C | Mean | Standard Deviation | percent glycated hemoglobin |
|
| Pre-existing Hypertension | Count of Participants | Participants |
|
| Number of living children | Mean | Full Range | number of children |
|
| Pre-pregnancy Insulin Use | Count of Participants | Participants |
|
|
|
| Primary | Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management | Individualized postpartum interviews and qualitative surveys administered at each time point will be used to gather information about participants thoughts and experiences in both arms of the trial about their ability to manage diabetes in pregnancy. Interviews will be analyzed for theme and content. Higher numbers indicate higher satisfaction with diabetes management. | Posted | Mean | Standard Deviation | number of times mentioned | baseline, 12 weeks on study, and postpartum (up to 26 weeks on study) |
|
|
|
| Primary | Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range | The primary endpoint is the total time within range (blood glucose level 70-140 mg/dL). All CGM data will be extracted from the Dexcom server for analysis. This measure is used to determine if time in range (TIR) is a suitable clinical endpoint for a larger trial. TIR for both arms will be determined and 95% confidence intervals around the difference in means calculated. TIR will be considered suitable if the upper 95% confidence interval for the difference in means is greater than 5 units in favor of CGM. | Posted | Mean | Full Range | percentage of time in range | Baseline, 26 weeks |
|
|
|
| Secondary | Number of Participants With Cesarean Delivery | Posted | Count of Participants | Participants | approximately 20 weeks on study (at time of delivery) |
|
|
|
| Secondary | Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester | Posted | Mean | 95% Confidence Interval | percentage of A1c | baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation) |
|
|
|
| Secondary | Percentage of Time Spent in Hyperglycemic Range | Hyperglycemic range is considered greater than 140 mg/dL. A very high hyperglycemic range is >250mg/dL. | Posted | Mean | 95% Confidence Interval | percentage of time | up to 26 weeks |
|
|
|
| Secondary | Percentage of Time Spent in Hypoglycemic Range | Hypoglycemic range is considered less than 70 mg/dL. Low is 55-70, very low is <54. | Posted | Mean | 95% Confidence Interval | percentage of time | 26 weeks |
|
|
|
| Secondary | Rates of Gestational Hypertension | Gestational hypertension is defined as systolic blood pressure 140 mm Hg or diastolic blood pressure 90 mg Hg on two occasions at least 4 hours apart. | Posted | Count of Participants | Participants | up to approximately 20 weeks on study |
|
|
|
| Secondary | Rates of Preeclampsia | Gestational hypertension plus either new-onset proteinuria [300 mg/24 hours, protein:creatinine 0.3 mg/dL], thrombocytopenia [platelet count<100,000/uL], elevated Aspartate transaminase or alanine transaminase [>2 upper limit of normal], renal insufficiency [serum creatinine>1.1 mg/dL or an unexplained doubling of creatinine], pulmonary edema, or cerebral or visual symptoms. | Posted | Count of Participants | Participants | up to approximately 20 weeks on study |
|
|
|
| Secondary | Rates of Polyhydramnios | Posted | Count of Participants | Participants | up to approximately 20 weeks on study |
|
|
|
| Secondary | Incidence of Neonatal Hypoglycemia | Posted | Count of Participants | Participants | up to 26 weeks |
|
|
|
| Secondary | Rates of Fetal Macrosomia | Actual birthweight greater than 95 percent by Fenton growth curve for newborns | Posted | Count of Participants | Participants | up to 26 weeks |
|
|
|
| Secondary | Rates of NICU Admission | Posted | Count of Participants | Participants | up to 26 weeks |
|
|
|
| Secondary | Rates of Spontaneous Preterm Delivery | Preterm delivery is considered less than 37 weeks. | Posted | Count of Participants | Participants | up to approximately 17 weeks on study (less than 37 weeks gestation) |
|
|
|
| Secondary | Satisfaction and Quality of Life Survey Scores (5-point Likert Scale) | Satisfaction and Quality of Life survey will be administered and answers will be compared between groups. Survey questions include answers on a 5-point Likert scale. Scores range from 15-75, where higher scores indicate lower satisfaction and quality of life, and lower scores indicate higher satisfaction and quality of life. | Some participants did not answer surveys at all time points. | Posted | Mean | 95% Confidence Interval | score on a scale | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| Secondary | Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings | The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity. | Posted | Number | Number of times comment made | 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| Secondary | Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring | Explore if traditional management versus continuous glucose management has higher feelings of control over diabetes management. The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity. | Posted | Number | Number of times comment made | 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| Secondary | Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | Some participants did not answer surveys at all timepoints. | Posted | Mean | Standard Deviation | score on a scale | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| Secondary | Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | Some participants did not answer surveys at all timepoints. | Posted | Mean | Standard Deviation | score on a scale | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| Secondary | Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | Some participants did not answer surveys at all timepoints. | Posted | Mean | Standard Deviation | score on a scale | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| Secondary | Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | Some participants did not answer surveys at all timepoints. | Posted | Mean | Standard Deviation | score on a scale | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| Secondary | Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes? | A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied | Some participants did not answer surveys at all timepoints. | Posted | Mean | Standard Deviation | score on a scale | at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Arm 2: Point of Care Glucose Testing (POCT) | Point of care finger sticks for glucose monitoring. At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data. Dexcom G6 CGM: Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data. Experimental Group will wear CGM for the duration of their pregnancy. Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy. Participant Finger Stick Glucose Monitoring: Standard of care for individual participant | 0 | 8 | 0 | 8 | 0 | 8 |
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| Baseline : Satisfied with pregnancy burden managing diabetes |
|
| 12 weeks: Comfortable managing diabetes before pregnancy |
|
| 12 weeks: Comfortable managing diabetes during and post pregnancy |
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| 12 weeks: Satisfied with pregnancy burden managing diabetes |
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| Postpartum: Comfortable managing diabetes before pregnancy |
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| Postpartum: Comfortable managing diabetes during and post pregnancy |
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| Postpartum: Satisfied with pregnancy burden managing diabetes |
|
| 28-32 weeks gestation |
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| 2-4 weeks postpartum |
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| Feeling like a burden on the healthcare system |
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| Feeling method is convenient |
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| Cost effectiveness |
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| Customer service ease with device |
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| Perception of device accuracy |
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| Dissatisfaction with finger sticks |
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| Feelings of guilt |
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| Impact of diabetes on pregnancy and concern |
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| Learning |
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| Mood |
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| Phone App satisfaction |
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| Stress |
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| Trouble with device |
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| Tools to improve control available |
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| Trouble remembering to monitor glucose |
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| 28-32 weeks |
|
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| Postpartum |
|
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| 28-32 weeks |
|
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| Postpartum |
|
|
| 28-32 weeks |
|
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| Postpartum |
|
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| 28-32 weeks |
|
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| Postpartum |
|
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| 28-32 weeks |
|
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| Postpartum |
|
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