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Type 1 Diabetes MellitusLOIS-PNCT03761615

Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy

An observational study of Type 1 Diabetes Mellitus and Pregnancy in Diabetics, run by Sansum Diabetes Research Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Dexcom G6 CGM
Type of treatment
Medical device
How many people
25 participants
Where
3 sitesUnited States
Study dates
13 Nov 2018to 9 Jun 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Dexcom G6 CGM
Keywords
type 1 diabetes, pregnancy, continues glucose monitoring, artificial pancreas
Medical subject headings
Diabetes Mellitus, Type 1, Pregnancy in Diabetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexcom G6 CGMDevice

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

Study groups in NCT03761615
Study groupRoleWhat they receive
type 1 diabetes and pregnancyPregnant 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.
Receives: Device: Dexcom G6 CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

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

    Time spent below target cgm glucose range defined as glucose <63 mg/dL

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

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

    Time spent above target cgm glucose range defined as >140 mg/dL

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

  3. Episodes of Clinically Significant Hyperglycemia

    Episodes of clinically significant hyperglycemia with CGM glucose >180 mg/dL

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

  4. Total Daily Insulin Requirements Over Last 2 Weeks of Third Trimester

    Total daily insulin requirements (units/kg/day) over last 2 weeks of third trimester

    Measured: 2 weeks

  5. Basal Insulin Requirements Over Last 2 Weeks of Third Trimester

    Basal daily insulin requirements (units/kg/day) over last 2 weeks of third trimester

    Measured: 2 weeks

  6. Carbohydrate Consumption Over Last 2 Weeks of Third Trimester

    Carbohydrate consumption (g/(kg*day)) over last 2 weeks of third trimester

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2018
  2. Study start13 Nov 2018
  3. Primary completion9 Jun 2021
  4. Study completion9 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761615
Sponsor's protocol ID
18-007081
Acronym
LOIS-P
Status last verified
Oct 2023
First submitted
24 Nov 2018
Last updated
12 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to create a public database of study results per NIH open data policy.

Publications

  • 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.

    PubMed 34270347

  • 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.

    PubMed 35349353

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus and Pregnancy in Diabetics, run by Sansum Diabetes Research Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time in Range Glucose Levels 63-140 mg/dL as Determined by CGM (time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03761615, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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