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Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy | Clinical Trials | Clareo Health

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Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

Observational Study of Patient Important Outcomes in Pregnant Patients With Type 1 Diabetes Mellitus on Insulin Pump

NCT03761615•Sansum Diabetes Research Institute

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.

Detailed Description

This is an observational study. Data collected will include records of continuous glucose monitoring (CGM) based glucose, insulin delivery, self-monitoring of blood glucose (SMBG), and maternal and fetal outcomes from pregnant women with type 1 diabetes. These data will be used to: (1) develop and refine algorithms for an AP system tailored to the needs of pregnant women with type 1 diabetes, (2) to serve as a comparator group for concurrent AP protocols, (3) describe Dexcom G6 CGM data throughout the pregnancy, and (4) describe insulin changes which occur in pregnancy.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

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.
+11 more criteria

Exclusion Criteria

•670 G users in Auto mode
•Current gestational age ≥17 weeks
•Cystic fibrosis
•A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
•* Inpatient psychiatric treatment in the past 6 months
•* Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty
•* Active gastroparesis
•* Abuse of alcohol or recreational drugs
•* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
•* Uncontrolled arterial hypertension (Resting diastolic blood pressure \>95mmHg and/or systolic blood pressure \>160 mmHg) at the time of screening
+2 more criteria

Locations (3)

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Key Dates

Start Date

November 13, 2018

Primary Completion Date

June 9, 2021

Completion Date

June 9, 2021

Last Updated

April 12, 2024

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes MellitusPregnancy in Diabetics

Interventions

Dexcom G6 CGM

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

Inclusion Criteria

Exclusion Criteria

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