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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities during pregnancy associated with T1DM.
A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities that enable subjects to share CGM data with family and friends (whom the investigators will call "followers" in this protocol) among women with T1DM associated with pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Care | No Intervention | Standard of Care in the Pregnancy and Women's Health clinic. | |
| Dexcom G4 Platinum CGM system | Active Comparator | An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy. |
|
| Dexcom G4 Platinum CGM system with Share™ | Active Comparator | A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G4 or G5 Platinum CGM system | Device | Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Glucose Variability | Glucose variability as measured by glucose excursions from CGM | From first pregnancy visit to delivery |
| Change(s) in Behavior and/or Concerns of Diabetics. | 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. | From first pregnancy visit to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1C. | Change in A1C with CGM alone and CGM with Share™ compared to no CGM use. | From first pregnancy visit to delivery |
| Evaluation of Maternal and Fetal Outcomes. | Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sarit Polsky, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34524020 | Derived | Shah VN, Snell-Bergeon JK, Demmitt JK, Joshee P, Garcetti R, Pyle L, Polsky S. Relationship Between Time-in-Range, HbA1c, and the Glucose Management Indicator in Pregnancies Complicated by Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):783-790. doi: 10.1089/dia.2021.0093. Epub 2021 Nov 3. | |
| 34115946 | Derived |
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Study cohorts: (1) women with T1D prospectively enrolled in 1st trimester or when planning pregnancy, (2) followers (family/friends) of women in the 1st cohort, and (3) women with T1D with a pregnancy within the past 3 years who did not use CGM therapy during gestation (retrospective). Follower data only included answers to monthly questionnaires.
From 08/2015 to 06/2016, investigators enrolled women in preconception and the 1st trimester at the Barbara Davis Center, and followers. Other women consented for the retrospective (no CGM) group. Follower data only included answers to monthly questionnaires. Study registration was delayed due to staffing issues and account set-up in the system.
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Care | Standard of Care in the Pregnancy and Women's Health clinic. |
| FG001 | Dexcom G4 Platinum CGM System | An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy. Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy |
| FG002 | Dexcom G4 Platinum CGM System With Share™ | A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy. Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ |
| FG003 | Followers for Dexcom Alone | Followers of Pregnant Women Using Dexcom Alone |
| FG004 | Followers for Dexcom Share | Followers of Pregnant Women Using Dexcom with Share |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline demographics data was not collected for the two "Followers" arms consisting of family/friends of the persons in the "Dexcom G4 Platinum CGM System" and "Dexcom G4 Platinum CGM System With Share™" arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Routine Care | Standard of Care in the Pregnancy and Women's Health clinic. |
| BG001 | Dexcom G4 Platinum CGM System | An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy. Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Changes in Glucose Variability | Glucose variability as measured by glucose excursions from CGM | CGM metrics among CGM Share and CGM Alone (not among no CGM since they did not use a CGM) | Posted | Median | Inter-Quartile Range | % time spent in range | From first pregnancy visit to delivery |
|
Pregnancy and up the the first 6 weeks post-partum, an average of 1 year, for prospectively enrolled study arms (CGM Share and CGM Alone)
Severe hypoglycemia was defined as glucose <70 mg/dL requiring the assistance of a third party. Miscarriage was defined as 1st trimester fetal loss (women who miscarried and became pregnant again during the enrollment period could re-enroll). Number at risk for miscarriage includes all pregnancies, but number at risk for mortality includes participants (not individual pregnancies). Adverse events were captured and recorded only in prospectively enrolled arms (does not include no CGM group).
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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 | Dexcom G4 Platinum CGM System | An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy. Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| severe hypoglycemic episode | Endocrine disorders | Systematic Assessment | Severe hypoglycemia was defined as hypoglycemia (glucose <70 mg/dL) requiring the assistance of a third party. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarit Polsky, MD, MPH | Regents of the University of Colorado | 3037248575 | sarit.polsky@ucdenver.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 17, 2016 | Jun 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Dexcom G4 or G5 Platinum CGM system with Share | Device | Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ |
|
| From first pregnancy visit to delivery |
| Buschur EO, Campbell K, Pyle L, Garcetti R, Joshee P, Demmitt JK, Snell-Bergeon JK, Polsky S. Exploratory Analysis of Glycemic Control and Variability Over Gestation Among Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Nov;23(11):768-772. doi: 10.1089/dia.2021.0138. |
| 31779476 | Derived | Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous Glucose Monitor Use With Remote Monitoring Reduces Fear of Hypoglycemia in Pregnant Women With Type 1 Diabetes: A Pilot Study. J Diabetes Sci Technol. 2020 Jan;14(1):191-192. doi: 10.1177/1932296819890864. Epub 2019 Nov 28. No abstract available. |
| BG002 | Dexcom G4 Platinum CGM System With Share™ | A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy. Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/ethnicity data were not obtained from retrospective chart review (no CGM) group. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Method of insulin delivery, n (%) | Count of Participants | Participants |
|
| Preconception hemoglobin A1C (%) | Median | Inter-Quartile Range | % |
|
|
|
| Primary | Change(s) in Behavior and/or Concerns of Diabetics. | 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. | Hypoglycemia Fear Survey results (higher scores indicate more behavioral changes, worry, or total fear scores). Only prospectively enrolled pregnant women were administered this questionnaire (CGM Alone and CGM Share groups). | Posted | Mean | Standard Deviation | score on a scale | From first pregnancy visit to delivery |
|
|
|
| Secondary | Change in A1C. | Change in A1C with CGM alone and CGM with Share™ compared to no CGM use. | Least squares mean HbA1c by group in a model without interaction and without adjustment for preconception HbA1c. | Posted | Least Squares Mean | Standard Error | HbA1C % | From first pregnancy visit to delivery |
|
|
|
| Secondary | Evaluation of Maternal and Fetal Outcomes. | Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures) | Maternal and fetal outcomes among prospective pregnant study arms (CGM Share and CGM Alone) | Posted | Count of Participants | Participants | From first pregnancy visit to delivery |
|
|
|
| 0 |
| 13 |
| 3 |
| 13 |
| 0 |
| 13 |
| EG001 | Dexcom G4 Platinum CGM System With Share™ | A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy. Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ | 0 | 15 | 4 | 15 | 0 | 15 |
| EG002 | Followers of Dexcom G4 Platinum CGM System | Followers (family or friends) of Dexcom G4 Platinum CGM system | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Followers of Dexcom G4 Platinum CGM System With Share™ | Followers (family or friends) of Dexcom G4 Platinum CGM system with Share™ | 0 | 14 | 0 | 14 | 0 | 14 |
|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Fetal loss within the 1st trimester |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian/Oriental |
|
| Other |
|
| Continuous subcutaneous insulin infusion (CSII) |
|
| Unknown |
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| Total Score (1st Trimester) |
|
| Behavior score (2nd trimester) |
|
| Worry Score (2nd Trimester) |
|
| Total Score (2nd Trimester) |
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| Behavior score (3rd trimester) |
|
| Worry Score (3rd Trimester) |
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| Total Score (3rd Trimester) |
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| <37 weeks gestation at delivery, n (%) |
|
| Large-for-gestational age infant, n (%) |
|
| Macrosomia, n (%) |
|
| Small-for-gestational age infant, n (%) |
|
| Neonatal hypoglycemia, n (%) |
|
| Neonatal jaundice, n (%) |
|
| Neonatal hypoxemia, n (%) |
|
| Neonatal intensive care unit admission, n (%) |
|
| Progression of diabetic retinopathy (both eyes) |
|
| Progression of diabetic retionpathy (one eye) |
|
| Progression of diabetic retinopathy (neither eye) |
|