N/A
N=25
Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy
Type 1 Diabetes Mellitus · Pregnancy in Diabetics
Bottom Line
View on ClinicalTrials.gov: NCT03761615 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Apr 2024
Primary outcome: Primary: Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM — 59 percentage of time
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dexcom G6 CGM (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sansum Diabetes Research Institute
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM |
59 | — |
| SECONDARY Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM |
3 | — |
| SECONDARY Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM |
38 | — |
| SECONDARY Episodes of Clinically Significant Hyperglycemia |
0.08 | — |
| SECONDARY Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester |
0.88 | — |
| SECONDARY Basal Insulin Requirements Over Last 2 Weeks of Third Trimester |
0.4 | — |
| SECONDARY Carbohydrate Consumption Over Last 2 Weeks of Third Trimester |
1.76 | — |
Summary
The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period. The investigators anticipate that when compared to subjects using an Artificial pancreas system (AP) as part of a future protocol, this comparator group of subjects undergoing usual care will exhibit less time in target continuous glucose monitoring (CGM) glucose range defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose <63 mg/dL.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis, based on investigator assessment, of T1D for at least one year and using insulin for at least 1 year.
- Criteria for documented hyperglycemia (at least 1 must be met):
- Fasting glucose ≥126 mg/dL
- Two-hour OGTT glucose ≥200 mg/dL
- HbA1c ≥6.5% documented
- Random glucose ≥200 mg/dL with symptoms
- No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with T1D
- Criteria for requiring insulin at diagnosis (1 must be met):
- Participant required insulin at diagnosis and continually thereafter.
- Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually.
- Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually.
- Currently using an insulin pump for diabetes management
- Currently using or willing to use an insulin-to-carbohydrate ratio to calculate meal bolus sizes
- Willing to change insulin infusion site at least every 3 days.
- Confirmed pregnancy
- Current gestational age 95mmHg and/or systolic blood pressure >160 mmHg) at the time of screening
- Chronic oral steroid use
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
Data sourced from ClinicalTrials.gov (NCT03761615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.