Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

NCT03761615 | Completed Results

• 1 other identifier: 18-007081
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 1 Diabetes Mellitus; Pregnancy in Diabetics

Keywords

type 1 diabetes; pregnancy; continues glucose monitoring; artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM

  Time in range defined as 63-140 mg/dL as determined by CGM analysis

  Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Secondary Outcomes (6)

• Percentage of Percentage of Time Spent Below Target Glucose (<63 mg/dL) as Determined by CGM

  Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

• Percentage of Time Spent Above Target Glucose Range (> 140 mg/dL) as Determined by CGM

  Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

• Episodes of Clinically Significant Hyperglycemia

  Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

• Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester

  2 weeks

• Basal Insulin Requirements Over Last 2 Weeks of Third Trimester

  2 weeks

Other Outcomes (9)

• Ketoacidosis

  Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

• Maternal Complications

  Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

• Gestational Weight Gain

  Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum

Study Arms (1)

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.

Device: Dexcom G6 CGM

Interventions

Dexcom G6 CGM DEVICE

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

type 1 diabetes and pregnancy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women 18 years of age or older with T1D using an insulin pump

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Harvard University: collaborator
• Mayo Clinic: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (3)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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.

  PMID: 34270347 RESULT

• 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.

  PMID: 35349353 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Dr. Kristin Castorino
• Organization: Sansum Diabetes Research Institute

info@sansum.org

805-682-7638

Study Officials

• Eyal Dassau, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Carol Levy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Yogish C Kudva, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Jordan E Pinsker, MD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

• Barak Rosenn, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Kristin Castorino, DO

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

• Grenye O'Malley, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2018
• First Posted: December 3, 2018
• Study Start: November 13, 2018
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after study data analysis is complete and results are published.

Locations

US (3)