Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

NCT ID: NCT03761615

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2021-06-09

Brief 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.

Conditions

Type 1 Diabetes Mellitus; Pregnancy in Diabetics

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

type 1 diabetes and pregnancy

Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes.

Dexcom G6 CGM

Intervention Type: DEVICE

All women in the study will be given Dexcom G6 CGM and a study glucometer.

Interventions

Dexcom G6 CGM

All women in the study will be given Dexcom G6 CGM and a study glucometer.

Intervention Type: DEVICE

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 <17 weeks
• Age 18-40 years
• HbA1c <10.0%
• Demonstration of proper mental status and cognition for the study
• Ability to access the internet and upload CGM data remotely if needed
• An understanding of and willingness to follow the protocol and sign the informed consent

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Harvard University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eyal Dassau, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Carol Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Yogish C Kudva, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Jordan E Pinsker, MD

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Barak Rosenn, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Kristin Castorino, DO

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Grenye O'Malley, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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

Countries

United States

References

O'Malley G, Ozaslan B, Levy CJ, Castorino K, Desjardins D, Levister C, McCrady-Spitzer S, Church MM, Kaur RJ, Reid C, Kremers WK, Doyle FJ, Trinidad MC, Rosenn B, Pinsker JE, Kudva YC, Dassau E. Longitudinal Observation of Insulin Use and Glucose Sensor Metrics in Pregnant Women with Type 1 Diabetes Using Continuous Glucose Monitors and Insulin Pumps: The LOIS-P Study. Diabetes Technol Ther. 2021 Dec;23(12):807-817. doi: 10.1089/dia.2021.0112. Epub 2021 Aug 17.

Reference Type: RESULT

PMID: 34270347 (View on PubMed)

Kaur RJ, Smith BH, Ozaslan B, Pinsker JE, Trinidad MC, O'Malley G, Desjardins D, Castorino KN, Levister C, Reid C, McCrady-Spitzer S, Ogyaadu SJ, Church MM, Piper M, Kremers WK, Rosenn B, Doyle FJ 3rd, Dassau E, Levy CJ, Kudva YC. Hypoglycemia in Prospective Multicenter Study of Pregnancies with Pre-Existing Type 1 Diabetes on Sensor-Augmented Pump Therapy: The LOIS-P Study. Diabetes Technol Ther. 2022 Aug;24(8):544-555. doi: 10.1089/dia.2021.0479.

Reference Type: RESULT

PMID: 35349353 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

18-007081

Identifier Type: -

Identifier Source: org_study_id