Pregestational Diabetes
Conditions
Keywords
postpartum, type 1 diabetes, type 2 diabetes, continuous glucose monitor
Brief summary
This study will examine whether continuous glucose monitoring in patients hospitalized in the immediate postpartum period is more effective than traditional point of care glucose testing in identifying patients with hypoglycemia.
Detailed description
This is a prospective cohort study of women with type 1 and type 2 diabetes in the postpartum period. After obtaining informed consent, a CGM device (Dexcom sensor and transmitter) will be placed by research personnel upon presentation to labor or in prenatal clinic if seen within 3 days of planned induction of labor or planned cesarean section. Patient will be assisted in getting the Dexcom G6 app on their cell phone to be the receiver of glucose data. Patients who are currently using the Dexcom CGM for routine monitoring of their glucoses, will be allowed to continue using their own sensor and transmitter. Upon presentation to Labor and Delivery, patients will be assisted in activating the Share App on their cell phone. Labor and Delivery Nursing Staff will be given a Samsun phone with the Follow app in order to receive glucose data. The Samsung phone will be transferred to the Mother/Baby Unit with the patient after delivery. Glucose values from the CGM device will then be available to nursing through the Samsung phone. Nursing will be able to see current glucose data on their patient and would receive alarms to indicate hypoglycemia or impending hypoglycemia. Nursing will be provided with instructions for how to access the CGM follow app and how to appropriately respond to the alarms. Nursing will continue to perform standard of care blood glucose monitoring per routine protocol but will also obtain a finger stick to validate a blood glucose level whenever a low CGM alarm sounds. Low blood glucose values \<70 mg/dl will be treated per local institutional nursing policy. Monitoring of glucose levels through the CGM device will continue throughout their postpartum hospital stay. This is typically 2 days for a vaginal delivery, 3 days for a cesarean section. Patients who do not use CGM as part of their routine care, will have their CGM sensor and transmitter removed prior to discharge from the hospital. Following discharge from the hospital, there will be no additional long term follow-up. Data we plan to collect for analysis includes: type of diabetes (DM1/DM2), point of care glucose values, number of hypoglycemic events, number of times treated for hypoglycemia.
Interventions
DEVICECGM
Continuous glucose monitoring
Sponsors
University of Iowa
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective cohort
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: 1- Individuals in the third trimester of pregnancy admitted to the hospital with diabetes type 1 or diabetes type 2, own a smart device (which will serve as a receiver for the CGM device) Exclusion: 1. Patients less than 18 years of age 2. non-English speaking patients 3. gestational diabetes 4. extensive skin changes/diseases that inhibit wearing a sensor on normal skin, known allergy to adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hypoglycemia During Postpartum Hospital Stay | Postpartum admission, 2-5 days | glucose values |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea Greiner, MD
University of Iowa OBGYN
Participant flow
Recruitment details
pregnant women with Type 1 and Type 2 Diabetes Mellitus delivering at the University of Iowa Hospitals and Clinics
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 0 Participants |
| Type of pregestational diabetes | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 26 |
| other Total, other adverse events | 0 / 13 | 0 / 26 |
| serious Total, serious adverse events | 0 / 13 | 0 / 26 |
Outcome results
None listed