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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| Ohio State University | OTHER |
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In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia. Hybrid closed-loop (HCL) therapy, automated insulin delivery using an insulin pump getting feedback from a continuous glucose monitor (CGM), may improve outcomes. This exploratory, novel pilot feasibility randomized clinical trial will evaluate pregnant women with type 1 diabetes (T1D) on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 2nd trimester, throughout pregnancy, and 4-6 weeks post-partum. Comparisons will be made on safety (Specific Aim [SA] 1), indices of glycemic variability and fear of hypoglycemia (SA 2), and quality of life and device satisfaction (SA 3) between groups. Exploratory SA 4 will compare maternal and fetal outcomes between groups. Safety data will include episodes of severe hypoglycemia requiring 3rd party assistance, diabetic ketoacidosis, and skin reactions. Glycemic control will be measured by CGM time spent in glucose ranges (<63, 63-140, >140 mg/dL) and other measures of glycemic variability. Subjects will fill out surveys (Fear of Hypoglycemia, a quality of life survey, and 2 questionnaires about device satisfaction) at baseline, throughout gestation, and early post-partum. Data on maternal and fetal outcomes will be collected. Findings will reveal the safety profile and glucose control with a novel therapy for pregnant women with type 1 diabetes.
This is a two-center, prospective, 'open-label', single-blind, investigator-initiated randomized controlled pilot study evaluating hybrid closed-loop (HCL) insulin delivery among pregnant women with T1D compared with sensor-augmented pump therapy (SAPT) throughout most of gestation and the first 6 weeks of the post-partum period at the Barbara Davis Center for Diabetes and Ohio State University.
Up to 37 women will be enrolled at ≤11 weeks gestation, sign informed consent, and begin a run-in phase. At baseline, the investigators will obtain data about demographics, health history, pregnancy history, and medication use. The investigators will conduct a physical exam, download diabetes devices already in use by subjects, obtain blood and urine tests, and administer validated questionnaires (Hypoglycemia Fear Survey, MOS Short-Form 36 [SF-26], INSPIRE Questionnaire, Insulin Delivery Satisfaction Survey [IDSS], and Glucose Monitoring Satisfaction Survey [GMSS]). During run-in, women will wear a CGM, fill out log sheets (glucose levels, insulin doses, carbohydrate intake, exercise), upload the CGM, and be in contact with research staff. Eligible subjects will then be trained on study devices for SAPT therapy. At the start of the 2nd trimester, women will be randomized to SAPT or HCL therapy.
During pregnancy, women will be seen at each institution monthly for vital signs, HbA1c measurements, device downloads, pump adjustments, medication use, reporting of adverse events and device-related deficiencies, and once a trimester the investigators will additionally obtain serum and urine measurements, specimens for the repository of biological specimens, and ask subjects to fill out questionnaires (Hypoglycemia Fear Survey, SF-35, IDSS, GMSS). Weekly remote contact will be obtained for pump adjustments and reporting of adverse events and device-related deficiencies. Women on HCL therapy will use SAPT during labor and delivery until 3-7 days post-partum, when a study clinician will put them back into auto mode (HCL therapy), if it is safe to do so. The final study visit will take place 4-6 weeks post-partum where the physical exam will be done, HbA1c obtained, device downloads obtained, and final questionnaires submitted (as above plus a post-partum survey). Medical records of the labor and delivery admission will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensor-augmented pump therapy (SAPT) | Active Comparator | Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system. |
|
| Hybrid closed-loop therapy (HCL) | Experimental | Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid closed-loop therapy | Device | Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Episodes of Severe Hypoglycemia | Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through the number of episodes of severe hypoglycemia requiring 3rd party assistance | through study completion, an average of 9 months |
| Time Spent With Glucose <54 mg/dL | Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through continuous glucose monitor time spent with glucose <54 mg/dL | Through study completion, an average of 9 months |
| Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Indices of glucose control are time spent in the glucose target ranges <54 mg/dL and <63 mg/dL (hypoglycemia), 63-140 mg/dL (time in range), and >140 mg/dL and >180 mg/dL (hyperglycemia) of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum | Through study completion, an average of 9 months |
| Fear of Hypoglycemia Score | Fear of hypoglycemia is assessed as behavior, worry, and total scores of fear of hypoglycemia determined by the Hypoglycemia Fear Survey of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum. Score Explanation: Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome. Subscales are added for the total scale score. Time Points: Baseline: 9 weeks gestation or earlier Visit 7: 18-20 weeks gestation Visit 10: 30-32 weeks gestation Visit 16: 4-6 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Episodes of Diabetic Ketoacidosis | Secondary safety assessed through the number of episodes of diabetic ketoacidosis of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period. | Through study completion, an average of 9 months |
| Number of Adverse Skin Reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarit Polsky, MD, MPH | Regents of the University of Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Ohio State University Wexner Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensor-augmented Pump Therapy (SAPT) | Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system. Sensor-augmented pump therapy: Insulin pump + non-communicating CGM |
| FG001 | Hybrid Closed-loop Therapy (HCL) | Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women. Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensor-augmented Pump Therapy (SAPT) | Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system. Sensor-augmented pump therapy: Insulin pump + non-communicating CGM |
| BG001 | Hybrid Closed-loop Therapy (HCL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Episodes of Severe Hypoglycemia | Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through the number of episodes of severe hypoglycemia requiring 3rd party assistance | Posted | Number | Number of Episodes | through study completion, an average of 9 months |
|
through study completion, an average of 9 months
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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 | Sensor-augmented Pump Therapy (SAPT) | Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system. Sensor-augmented pump therapy: Insulin pump + non-communicating CGM |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal Demise | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Fetal demise one day after randomization into the HCL group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Pre-viable pregnancy loss |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarit Polsky | Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus | 303-724-8575 | sarit.polsky@cuanschutz.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 | Jan 19, 2021 | Jul 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D011254 | Pregnancy in Diabetics |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized clinical trial
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Biostatistician is blinded to intervention assignment
| Sensor-augmented pump therapy | Device | Insulin pump + non-communicating CGM |
|
|
| Through study completion, an average of 9 months |
Secondary safety assessed through the number of adverse skin reactions of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period |
| through study completion, an average of 9 months |
| Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as mean glucose ± standard deviation in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum | through study completion, an average of 9 months |
| Secondary Indices of Glucose Control: J-index | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as J index in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. J index is a measure of the quality of glycemic control. Lower values represent more glycemic control and higher values represent less glycemic control. Formula: J-Index= 0.001 x (mean blood glucose level + SD)^2 The J-Index has not been validated in this population of Type 1 Diabetes pregnancies. | through study completion, an average of 9 months |
| Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as High Blood Glucose Index (HBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. HBGI is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The range of values is 0-100 with 0 indicating no risk of high blood sugar and 100 indicating maximum possible risk of high blood sugar. | through study completion, an average of 9 months |
| Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Low Blood Glucose Index (LBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. LBGI is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The range is from 0-100 with 0 indicating no risk of low blood sugar and 100 indicating maximum possible risk of low blood sugar. | through study completion, an average of 9 months |
| Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Mean Amplitude of Glycemic Excursions (MAGE) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. MAGE is the average difference between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of the average value of glucose in a given day. Lower values represent less glycemic variability on average. Higher values represent more glycemic variability on average. | through study completion, an average of 9 months |
| Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Continuous Overall Net Glycemic Action (CONGAn) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. CONGAn assesses glycemic variability by calculating the difference between the glucose values taken at different timeframes. Lower values represent less glycemic differences between the timepoints. Higher values represent more glycemic differences between timepoints. | through study completion, an average of 9 months |
| Medical Outcomes Study (MOS) Short-Form 36 Score | Quality of life as measured by scores from the MOS Short-Form 36 (quality of life) of HCL and SAPT arms in pregnant women with T1D. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health | through study completion, an average of 9 months |
| INSPIRE Questionnaire Score | Quality of life as measured by scores from the INSPIRE questionnaire of HCL in pregnant women with T1D. The INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a survey consisting of 22 questions that assess user expectations and experiences with automated insulin delivery systems. Scores are calculated by determining the mean of the sum of all questions then multiplying the mean by 25 for a range of 0 to 100. Higher scores indicate more positive perceptions of the system. Each survey question uses a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). | through study completion, an average of 9 months |
| Insulin Delivery Satisfaction Survey (IDSS) Score | Device acceptability as measured by scores from the Insulin Delivery Satisfaction Survey of HCL and SAPT arms in pregnant women with T1D. The IDSS scale has a total score and 3 subscales: effective, burdensome, and inconvenient. Possible scores range from 1-5, with higher scores indicating higher satisfaction with insulin delivery system. Scores are reflective of the mean of the Total or subscale questions. | through study completion, an average of 9 months |
| Glucose Monitoring Satisfaction Survey (GMSS) Score | Device acceptability as measured by scores from the Glucose Monitoring Satisfaction Survey questionnaires of HCL compared to SAPT in pregnancy women with T1D. The GMSS has a total score and 4 subscales: openness, emotional burden, behavioral burden, and trust. Possible scores range from 1-5, with higher total scores indicating greater satisfaction. Scores are reflective of the mean of the Total or subscale questions. | through study completion, an average of 9 months |
| Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia | Maternal outcomes includes preeclampsia/eclampsia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | through study completion, an average of 9 months |
| Maternal Outcomes: Number of Participants With Cesarean Delivery | Maternal outcomes includes cesarean delivery in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | through study completion, an average of 9 months |
| Maternal Outcomes: Average Gestational Weight Gain | Maternal outcomes includes gestational weight gain in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | through study completion, an average of 9 months |
| Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth) | Fetal outcomes includes fetal loss (miscarriage or stillbirth) in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | through study completion, an average of 9 months |
| Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome | Fetal outcomes includes large-for-gestational age in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | through study completion, an average of 9 months |
| Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants | Fetal outcomes includes neonatal hypoglycemia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | through study completion, an average of 9 months |
| Columbus |
| Ohio |
| 43210 |
| United States |
Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women. Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data not available for 3 participants | Count of Participants | Participants |
|
| Education | Data missing for 1 in SAPT Group | Count of Participants | Participants |
|
| Insurance Type | Count of Participants | Participants |
|
| Multiparity | Count of Participants | Participants |
|
| Tobacco Use | Missing data for 1 in SAPT Group | Count of Participants | Participants |
|
| Insulin Pump Use Prior to Pregnancy | Count of Participants | Participants |
|
| CGM Use Prior to Pregnancy | Count of Participants | Participants |
|
|
|
| Primary | Time Spent With Glucose <54 mg/dL | Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through continuous glucose monitor time spent with glucose <54 mg/dL | Posted | Mean | Standard Error | percentage of time spent in range | Through study completion, an average of 9 months |
|
|
|
| Primary | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Indices of glucose control are time spent in the glucose target ranges <54 mg/dL and <63 mg/dL (hypoglycemia), 63-140 mg/dL (time in range), and >140 mg/dL and >180 mg/dL (hyperglycemia) of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum | Posted | Mean | Standard Error | percentage of time spent in range | Through study completion, an average of 9 months |
|
|
|
| Primary | Fear of Hypoglycemia Score | Fear of hypoglycemia is assessed as behavior, worry, and total scores of fear of hypoglycemia determined by the Hypoglycemia Fear Survey of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum. Score Explanation: Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome. Subscales are added for the total scale score. Time Points: Baseline: 9 weeks gestation or earlier Visit 7: 18-20 weeks gestation Visit 10: 30-32 weeks gestation Visit 16: 4-6 weeks after delivery | Posted | Mean | Standard Error | score on a scale | Through study completion, an average of 9 months |
|
|
|
| Secondary | Number of Episodes of Diabetic Ketoacidosis | Secondary safety assessed through the number of episodes of diabetic ketoacidosis of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period. | Posted | Number | Number of Episodes | Through study completion, an average of 9 months |
|
|
|
| Secondary | Number of Adverse Skin Reactions | Secondary safety assessed through the number of adverse skin reactions of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period | Posted | Number | Number of Reactions | through study completion, an average of 9 months |
|
|
|
| Secondary | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as mean glucose ± standard deviation in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum | The HCL group had 11 participants complete the study after randomization | Posted | Mean | Standard Deviation | mg/dL | through study completion, an average of 9 months |
|
|
|
| Secondary | Secondary Indices of Glucose Control: J-index | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as J index in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. J index is a measure of the quality of glycemic control. Lower values represent more glycemic control and higher values represent less glycemic control. Formula: J-Index= 0.001 x (mean blood glucose level + SD)^2 The J-Index has not been validated in this population of Type 1 Diabetes pregnancies. | The HCL group had 11 participants complete the study after randomization | Posted | Mean | Standard Error | mg/dL | through study completion, an average of 9 months |
|
|
|
| Secondary | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as High Blood Glucose Index (HBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. HBGI is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The range of values is 0-100 with 0 indicating no risk of high blood sugar and 100 indicating maximum possible risk of high blood sugar. | The HCL group had 11 participants complete the study after randomization | Posted | Mean | Standard Error | score on a scale | through study completion, an average of 9 months |
|
|
|
| Secondary | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Low Blood Glucose Index (LBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. LBGI is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The range is from 0-100 with 0 indicating no risk of low blood sugar and 100 indicating maximum possible risk of low blood sugar. | The HCL group had 11 participants complete the study after randomization | Posted | Mean | Standard Error | score on a scale | through study completion, an average of 9 months |
|
|
|
| Secondary | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Mean Amplitude of Glycemic Excursions (MAGE) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. MAGE is the average difference between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of the average value of glucose in a given day. Lower values represent less glycemic variability on average. Higher values represent more glycemic variability on average. | The HCL group had 11 participants complete the study after randomization | Posted | Mean | Standard Error | mg/dL | through study completion, an average of 9 months |
|
|
|
| Secondary | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Continuous Overall Net Glycemic Action (CONGAn) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. CONGAn assesses glycemic variability by calculating the difference between the glucose values taken at different timeframes. Lower values represent less glycemic differences between the timepoints. Higher values represent more glycemic differences between timepoints. | The HCL group had 11 participants complete the study after randomization | Posted | Mean | Standard Error | mg/dL | through study completion, an average of 9 months |
|
|
|
| Secondary | Medical Outcomes Study (MOS) Short-Form 36 Score | Quality of life as measured by scores from the MOS Short-Form 36 (quality of life) of HCL and SAPT arms in pregnant women with T1D. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 9 months |
|
|
|
| Secondary | INSPIRE Questionnaire Score | Quality of life as measured by scores from the INSPIRE questionnaire of HCL in pregnant women with T1D. The INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a survey consisting of 22 questions that assess user expectations and experiences with automated insulin delivery systems. Scores are calculated by determining the mean of the sum of all questions then multiplying the mean by 25 for a range of 0 to 100. Higher scores indicate more positive perceptions of the system. Each survey question uses a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). | INSPIRE Questionnaire only among HCL randomized group | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 9 months |
|
|
|
| Secondary | Insulin Delivery Satisfaction Survey (IDSS) Score | Device acceptability as measured by scores from the Insulin Delivery Satisfaction Survey of HCL and SAPT arms in pregnant women with T1D. The IDSS scale has a total score and 3 subscales: effective, burdensome, and inconvenient. Possible scores range from 1-5, with higher scores indicating higher satisfaction with insulin delivery system. Scores are reflective of the mean of the Total or subscale questions. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 9 months |
|
|
|
| Secondary | Glucose Monitoring Satisfaction Survey (GMSS) Score | Device acceptability as measured by scores from the Glucose Monitoring Satisfaction Survey questionnaires of HCL compared to SAPT in pregnancy women with T1D. The GMSS has a total score and 4 subscales: openness, emotional burden, behavioral burden, and trust. Possible scores range from 1-5, with higher total scores indicating greater satisfaction. Scores are reflective of the mean of the Total or subscale questions. | Posted | Mean | Standard Deviation | score on a scale | through study completion, an average of 9 months |
|
|
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| Secondary | Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia | Maternal outcomes includes preeclampsia/eclampsia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | Posted | Count of Participants | Participants | through study completion, an average of 9 months |
|
|
|
| Secondary | Maternal Outcomes: Number of Participants With Cesarean Delivery | Maternal outcomes includes cesarean delivery in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | Posted | Count of Participants | Participants | through study completion, an average of 9 months |
|
|
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| Secondary | Maternal Outcomes: Average Gestational Weight Gain | Maternal outcomes includes gestational weight gain in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | Posted | Mean | Standard Deviation | kg | through study completion, an average of 9 months |
|
|
|
| Secondary | Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth) | Fetal outcomes includes fetal loss (miscarriage or stillbirth) in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | Posted | Count of Participants | Participants | through study completion, an average of 9 months |
|
|
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| Secondary | Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome | Fetal outcomes includes large-for-gestational age in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | Posted | Count of Participants | Participants | through study completion, an average of 9 months |
|
|
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| Secondary | Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants | Fetal outcomes includes neonatal hypoglycemia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period | Posted | Count of Participants | Participants | through study completion, an average of 9 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 10 |
| 12 |
| EG001 | Hybrid Closed-loop Therapy (HCL) | Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women. Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm | 0 | 12 | 6 | 12 | 11 | 12 |
|
| DKA | Endocrine disorders | Systematic Assessment | Diabetic Ketoacidosis |
|
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| Preeclampsia with Severe Features | Cardiac disorders | Systematic Assessment |
|
| Chronic Hypertension with Superimpose Preeclampsia with Severe Features | Cardiac disorders | Systematic Assessment |
|
|
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Preterm Birth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Delivery before 37 weeks gestation |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Ketonuria | Endocrine disorders | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| Gestational Hypertension | Cardiac disorders | Systematic Assessment |
|
| Preeclampsia without Severe Features | Cardiac disorders | Systematic Assessment |
|
| Illness | Infections and infestations | Systematic Assessment | Cold, COVID-19 infection, Upper Respiratory Illness/Infection, Respiratory Virus, Sinus Infection |
|
| Sensor Site Irritation | Product Issues | Systematic Assessment | Bleeding, Bruising or Skin Irritation at Sensor Site |
|
| Post-Partum Depression/Anxiety | Psychiatric disorders | Systematic Assessment | The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization. |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypothyroidism | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal or Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache/Migraine | General disorders | Systematic Assessment |
|
| Ovarian Cyst | Reproductive system and breast disorders | Systematic Assessment |
|
| Nausea/Vomiting | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Large for Gestational Age Infant | General disorders | Systematic Assessment | The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization. |
|
| Yeast Infection | Reproductive system and breast disorders | Systematic Assessment |
|
| Tenosynovitis | General disorders | Systematic Assessment |
|
| Mastitis | Reproductive system and breast disorders | Systematic Assessment |
|
| Neonatal Hypoglycemia | General disorders | Systematic Assessment | The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization. |
|
| Seasonal Allergies | Immune system disorders | Systematic Assessment |
|
| Vaginal Aching | Reproductive system and breast disorders | Systematic Assessment |
|
| Infant Respiratory Distress | General disorders | Systematic Assessment | The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization. |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Post-Partum Pain | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization. |
|
| Pelvic Pain | General disorders | Systematic Assessment |
|
| Mild Post-Partum Hypertension | Cardiac disorders | Systematic Assessment |
|
| Food Poisoning | Gastrointestinal disorders | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | Systematic Assessment |
|
| Ankle/Feet Swelling | General disorders | Systematic Assessment |
|
| Carpal Tunnel | Nervous system disorders | Systematic Assessment |
|
| Foot Pain | General disorders | Systematic Assessment |
|
| Placental Hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Fetal Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Fetal Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Blood Ketones | Endocrine disorders | Systematic Assessment |
|
| Increased Fetal Movement | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Infant Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Infant Laryngomalacia/ Supraglottic Edema | General disorders | Systematic Assessment |
|
| Short Cervix | Reproductive system and breast disorders | Systematic Assessment |
|
| Hip Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leg Bruising | General disorders | Systematic Assessment | Not related to sensor site placement |
|
| Vaginal Bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Elevated Blood Pressure (Mild) | Cardiac disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infant Shoulder Dystocia | General disorders | Systematic Assessment |
|
| Hives | Immune system disorders | Systematic Assessment |
|
| Finger Wart | General disorders | Systematic Assessment |
|
| Abnormal Ultrasound Findings | General disorders | Systematic Assessment |
|
| Scratched Cornea | Eye disorders | Systematic Assessment |
|
| Eczema Flare-Up | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Non-Reassuring Fetal Wellbeing | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Associate's Degree |
|
| Bachelor's Degree |
|
| Master's Degree |
|
| Doctorate |
|
| Commercial |
|
| Other |
|
| Time spent with glucose <54 mg/dL (3rd Trimester) |
|
| Time spent with glucose <54 mg/dL (Postpartum) |
|
| Time spent <54 mg/ dL (3rd Trimester) |
|
| Time spent <54 mg/ dL (Postpartum) |
|
| Time spent <63 mg/ dL (1st trimester) |
|
| Time spent <63 mg/ dL (2nd trimester) |
|
| Time spent <63 mg/ dL (3rd trimester) |
|
| Time spent <63 mg/ dL (Postpartum) |
|
| Time spent 63-140 mg/ dL (1st Trimester) |
|
| Time spent 63-140 mg/ dL (2nd Trimester) |
|
| Time spent 63-140 mg/ dL (3rd Trimester) |
|
| Time spent 63-140 mg/ dL (Postpartum) |
|
| Time spent >140 mg/ dL (1st Trimester) |
|
| Time spent >140 mg/ dL (2nd Trimester) |
|
| Time spent >140 mg/ dL (3rd Trimester) |
|
| Time spent >140 mg/ dL (Postpartum) |
|
| Time spent >180 mg/ dL (1st Trimester) |
|
| Time spent >180 mg/ dL (2nd Trimester) |
|
| Time spent >180 mg/ dL (3rd Trimester) |
|
| Time spent >180 mg/ dL (Postpartum) |
|
| Total Score Visit 10 |
|
| Total Score Visit 16 (postpartum) |
|
| Worry Score Baseline |
|
| Worry Score Visit 7 |
|
| Worry Score Visit 10 |
|
| Worry Score Visit 16 (postpartum) |
|
| Behavior Score Baseline |
|
| Behavior Score Visit 7 |
|
| Behavior Score Visit 10 |
|
| Behavior Score Visit 16 (postpartum) |
|
| 2nd Trimester |
|
|
| 3rd Trimester |
|
|
| Postpartum |
|
|
| J-Index (1st Trimester) |
|
|
| J-Index (2nd Trimester) |
|
|
| J-Index (3rd Trimester) |
|
|
| J-Index (Post-Partum) |
|
|
| HBGI (1st Trimester) |
|
|
| HBGI (2nd Trimester) |
|
|
| HBGI (3rd Trimester) |
|
|
| HBGI (Post-Partum) |
|
|
| LBGI (1st Trimester) |
|
|
| LBGI (2nd Trimester) |
|
|
| LBGI (3rd Trimester) |
|
|
| LBGI (Post-Partum) |
|
|
| MAGE (1st Trimester) |
|
|
| MAGE (2nd Trimester) |
|
|
| MAGE (3rd Trimester) |
|
|
| MAGE (Post-Partum) |
|
|
| CONGAn (1st Trimester) |
|
|
| CONGAn (2nd Trimester) |
|
|
| CONGAn (3rd Trimester) |
|
|
| CONGAn (Post-Partum) |
|
|
| SF36 Total (3rd Trimester) |
|
| SF36 Total (Postpartum) |
|
| SF36 General Health (1st Trimester) |
|
| SF36 General Health (2nd Trimester) |
|
| SF36 General Health (3rd Trimester) |
|
| SF36 General Health (Postpartum) |
|
| SF36 Pain (1st Trimester) |
|
| SF36 Pain (2nd Trimester) |
|
| SF36 Pain (3rd Trimester) |
|
| SF36 Pain (Postpartum) |
|
| SF36 Social Functioning (1st Trimester) |
|
| SF36 Social Functioning (2nd Trimester) |
|
| SF36 Social Functioning (3rd Trimester) |
|
| SF36 Social Functioning (Postpartum) |
|
| SF36 Emotional Wellbeing (1st Trimester) |
|
| SF36 Emotional Wellbeing (2nd Trimester) |
|
| SF36 Emotional Wellbeing (3rd Trimester) |
|
| SF36 Emotional Wellbeing (Postpartum) |
|
| SF36 Energy (1st Trimester) |
|
| SF36 Energy (2nd Trimester) |
|
| SF36 Energy (3rd Trimester) |
|
| SF36 Energy (Postpartum) |
|
| SF36 Emotional Limits (1st Trimester) |
|
| SF36 Emotional Limits (2nd Trimester) |
|
| SF36 Emotional Limits (3rd Trimester) |
|
| SF36 Emotional Limits (Postpartum) |
|
| SF36 Physical Health Limits (1st Trimester) |
|
| SF36 Physical Health Limits (2nd Trimester) |
|
| SF36 Physical Health Limits (3rd Trimester) |
|
| SF36 Physical Health Limits (Postpartum) |
|
| SF36 Physical Functioning (1st Trimester) |
|
| SF36 Physical Functioning (2nd Trimester) |
|
| SF36 Physical Functioning (3rd Trimester) |
|
| SF36 Physical Functioning (Postpartum) |
|
| Title | Measurements |
|---|---|
|
| Post-Partum |
|
| IDSS Total (3rd Trimester) |
|
| IDSS Total (Postpartum) |
|
| IDSS Effective (1st Trimester) |
|
| IDSS Effective (2nd Trimester) |
|
| IDSS Effective (3rd Trimester) |
|
| IDSS Effective (Postpartum) |
|
| IDSS Burdensome (1st Trimester) |
|
| IDSS Burdensome (2nd Trimester) |
|
| IDSS Burdensome (3rd Trimester) |
|
| IDSS Burdensome (Postpartum) |
|
| IDSS Inconvenient (1st Trimester) |
|
| IDSS Inconvenient (2nd Trimester) |
|
| IDSS Inconvenient (3rd Trimester) |
|
| IDSS Inconvenient (Postpartum) |
|
| GMSS Total (3rd Trimester) |
|
| GMSS Total (Postpartum) |
|
| GMSS Trust (1st Trimester) |
|
| GMSS Trust (2nd Trimester) |
|
| GMSS Trust (3rd Trimester) |
|
| GMSS Trust (Postpartum) |
|
| GMSS Behavioral Burden (1st Trimester) |
|
| GMSS Behavioral Burden (2nd Trimester) |
|
| GMSS Behavioral Burden (3rd Trimester) |
|
| GMSS Behavioral Burden (Postpartum) |
|
| GMSS Emotional Burden (1st Trimester) |
|
| GMSS Emotional Burden (2nd Trimester) |
|
| GMSS Emotional Burden (3rd Trimester) |
|
| GMSS Emotional Burden (Postpartum) |
|
| GMSS Openness (1st Trimester) |
|
| GMSS Openness (2nd Trimester) |
|
| GMSS Openness (3rd Trimester) |
|
| GMSS Openness (Postpartum) |
|