Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy (Timely)

March 19, 2024 updated by: Mount Sinai Hospital, Canada

Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)

Prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Denice Feig, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant Women with Type 2 diabetes with either a HbA1c of >6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT

Description

Inclusion Criteria:

  1. Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of >6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above.
  2. ≤14 weeks gestation,
  3. age ≥18 years
  4. Willingness to use the study devices a minimum of 10 days per trimester
  5. Able to provide informed consent
  6. Have access to email

Exclusion Criteria:

  1. Non-type 2 diabetes
  2. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
  3. Known or suspected allergy against insulin
  4. Women with nephropathy (eGFR<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results
  5. Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
  6. Unable to communicate effectively in English as judged by the investigator
  7. Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time in target range
Time Frame: 7-9 months
To determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis
7-9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delivery outcome
Time Frame: 7-9 months
delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination.
7-9 months
Maternal outcome
Time Frame: 7-9 months
Date and time of hospital admission for delivery and discharge.
7-9 months
Maternal outcome (HTN)
Time Frame: 7-9 months
Maternal postpartum diagnosis of hypertension or pre-eclampsia.
7-9 months
Neonatal weight at birth
Time Frame: 7-9 months (Delivery of neonate)
Neonatal weight measurement collected from medical chart.
7-9 months (Delivery of neonate)
Neonatal outcomes (hypoglycemia)
Time Frame: 7-9 months (Delivery of neonate)
Proportion of babies born with hypoglycemia. The lowest recorded glucose value (mmol/L) will be collected for babies born with hypoglycemia
7-9 months (Delivery of neonate)
Neonatal outcomes (chromosomal abnormality)
Time Frame: 7-9 months (Delivery of neonate)
Proportion of babies born with chromosomal abnormality and type of chromosomal abnormality
7-9 months (Delivery of neonate)
Neonatal outcomes (congenital anomaly)
Time Frame: 7-9 months (Delivery of neonate)
Proportion of babies born with congenital anomaly and type of congenital anomaly
7-9 months (Delivery of neonate)
Neonatal outcomes (birth injury)
Time Frame: 7-9 months (Delivery of neonate)
Proportion of babies born with neonatal birth injury and type of injury
7-9 months (Delivery of neonate)
Neonatal outcomes (hyperbilirubinemia)
Time Frame: 7-9 months (Delivery of neonate)
Proportion of babies born with neonatal hyperbilirubinemia requiring treatment (• phototherapy > 6 continuous hours, an exchange transfusion, intravenous gamma globulin or required re-admission into hospital during the first 7 days of life)
7-9 months (Delivery of neonate)
Neonatal outcomes (neonatal intensive care admission)
Time Frame: Delivery of neonate to 6 weeks postpartum
Proportion of babies admitted to neonatal intensive care admission
Delivery of neonate to 6 weeks postpartum
Covariates (maternal obesity)
Time Frame: 16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum
maternal weight will be collected/measured
16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum
Covariates (maternal ethnicity)
Time Frame: Enrollment (16-24 weeks gestation)
maternal ethnicity will be collected
Enrollment (16-24 weeks gestation)
Covariates (Mother's total household income)
Time Frame: enrollment 16-24 weeks gestation
total household income will be collected
enrollment 16-24 weeks gestation
Adverse events
Time Frame: 7-9 months
Adverse events description and time of occurrence will be recorded when applicable
7-9 months
Blood Insulin
Time Frame: at 16-24 weeks gestation
blood insulin measured in pmol/L.
at 16-24 weeks gestation
Measures of insulin resistance (HOMA-IR )
Time Frame: at 16-24 weeks gestation
Homeostatic Model Assessment for Insulin Resistance ( HOMA-IR ) index will be calculated suing blood insulin and blood glucose
at 16-24 weeks gestation
Mean blood glucose measurement
Time Frame: at 16-24 weeks gestation
Blood glucose measured in mmol/L
at 16-24 weeks gestation
Diabetes distress
Time Frame: at 16-24 weeks gestation and at 34 weeks gestation
Using Diabetes Distress Screening Scale (DDSS17). The scale yields an overall distress score based on the average of response on the 1-6 scale for all 18 items. The DDS-17 identifies three levels of specificity of diabetes distress information for use in clinical care, from overall emotional distress related to diabetes to highly specific sources of diabetes distress. Higher score is worse.
at 16-24 weeks gestation and at 34 weeks gestation
Sleep quality
Time Frame: at 16-24 weeks gestation and at 34 weeks gestation
Using the Berlin Questionnaire. The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive
at 16-24 weeks gestation and at 34 weeks gestation
Sleep apnea
Time Frame: at 16-24 weeks gestation and at 34 weeks gestation
Using the Berlin Questionnaire. The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive
at 16-24 weeks gestation and at 34 weeks gestation
Perceived social support
Time Frame: 16-24 weeks gestation
Using the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS is a 12-item scale that measures the adequacy of social support. It consists of 3 subgroups that include items about family, friends and social support from a special person. It consists of 4 items for each group and each item is graded on a 7-item likert scale. A high total score indicates a high level of perceived social support.
16-24 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mount Sinai Hospital, Canada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Manitoba
Women's College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Denice Feig, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-0065-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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