Diabete Type 2TimelyNCT06147466
Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy
An observational study of Diabete Type 2 and Pregnancy in Diabetic, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Pregnancy in Diabetic
- What is being tested?
- Dexcom Continuous Glucose Monitoring
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
- ≤14 weeks gestation,
- age ≥18 years
- Willingness to use the study devices a minimum of 10 days per trimester
- Able to provide informed consent
- Have access to email
Who cannot join
- Non-type 2 diabetes
- Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
- Known or suspected allergy against insulin
- 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
- Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
- Unable to communicate effectively in English as judged by the investigator
- Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
Denice Feig, MD
About this study
Official title: 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
- Conditions
- Diabete Type 2, Pregnancy in Diabetic
- Being tested
- Dexcom Continuous Glucose Monitoring
- Keywords
- glucose range, neonatal outcomes, glycemic control, hypoglycemia, insulin resistance, preganant, pregnancy, CGM, Continuous Glucose Monitoring, Dexcom, maternal outcomes, Pregnancy in Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Pregnancy in Diabetics, Hypoglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Continuous Glucose MonitoringDevice
A continuous glucose monitor (CGM) is a wearable device that tracks blood glucose (sugar) every few minutes, throughout the day and night. The readings are relayed in real time to a device which can be read by the patient, caregiver or health-care provider, even remotely
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in target range
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
Measured: 7-9 months
Secondary outcomes (21)
Delivery outcome
delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination.
Measured: 7-9 months
Maternal outcome
Date and time of hospital admission for delivery and discharge.
Measured: 7-9 months
Maternal outcome (HTN)
Maternal postpartum diagnosis of hypertension or pre-eclampsia.
Measured: 7-9 months
Neonatal weight at birth
Neonatal weight measurement collected from medical chart.
Measured: 7-9 months (Delivery of neonate)
Neonatal outcomes (hypoglycemia)
Proportion of babies born with hypoglycemia. The lowest recorded glucose value (mmol/L) will be collected for babies born with hypoglycemia
Measured: 7-9 months (Delivery of neonate)
Neonatal outcomes (chromosomal abnormality)
Proportion of babies born with chromosomal abnormality and type of chromosomal abnormality
Measured: 7-9 months (Delivery of neonate)
Neonatal outcomes (congenital anomaly)
Proportion of babies born with congenital anomaly and type of congenital anomaly
Measured: 7-9 months (Delivery of neonate)
Neonatal outcomes (birth injury)
Proportion of babies born with neonatal birth injury and type of injury
Measured: 7-9 months (Delivery of neonate)
Neonatal outcomes (hyperbilirubinemia)
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)
Measured: 7-9 months (Delivery of neonate)
Neonatal outcomes (neonatal intensive care admission)
Proportion of babies admitted to neonatal intensive care admission
Measured: Delivery of neonate to 6 weeks postpartum
Covariates (maternal obesity)
maternal weight will be collected/measured
Measured: 16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum
Covariates (maternal ethnicity)
maternal ethnicity will be collected
Measured: Enrollment (16-24 weeks gestation)
Covariates (Mother's total household income)
total household income will be collected
Measured: enrollment 16-24 weeks gestation
Adverse events
Adverse events description and time of occurrence will be recorded when applicable
Measured: 7-9 months
Blood Insulin
blood insulin measured in pmol/L.
Measured: at 16-24 weeks gestation
Measures of insulin resistance (HOMA-IR )
Homeostatic Model Assessment for Insulin Resistance ( HOMA-IR ) index will be calculated suing blood insulin and blood glucose
Measured: at 16-24 weeks gestation
Mean blood glucose measurement
Blood glucose measured in mmol/L
Measured: at 16-24 weeks gestation
Diabetes distress
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.
Measured: at 16-24 weeks gestation and at 34 weeks gestation
Sleep quality
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
Measured: at 16-24 weeks gestation and at 34 weeks gestation
Sleep apnea
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
Measured: at 16-24 weeks gestation and at 34 weeks gestation
Perceived social support
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.
Measured: 16-24 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba, Women's College Hospital
- Responsible party
- Sponsor
- Investigators
- Denice Feig, Principal investigator, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147466
- Sponsor's protocol ID
- 21-0065-E
- Acronym
- Timely
- Status last verified
- Mar 2023
- First submitted
- 3 Apr 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)
- ClinicalTrials.gov ID
- NCT06147466
- Acronym / sponsor ID
- Timely / 21-0065-E
- Conditions
- Diabete Type 2, Pregnancy in Diabetic
- Keywords
- glucose range, neonatal outcomes, glycemic control, hypoglycemia, insulin resistance, preganant, pregnancy, CGM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- University of Manitoba, Women's College Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
- ≤14 weeks gestation,
- age ≥18 years
- Willingness to use the study devices a minimum of 10 days per trimester
- Able to provide informed consent
Key exclusion criteria (7 listed)
- Non-type 2 diabetes
- Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
- Known or suspected allergy against insulin
- 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
- Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom Continuous Glucose MonitoringA continuous glucose monitor (CGM) is a wearable device that tracks blood glucose (sugar) every few minutes, throughout the day and night. The readings are relayed in real time to a device which can be read by the patient, caregiver or health-care provider, even remotely | Device | – |
Primary outcome
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
21 secondary outcomes
Delivery outcome
Time frame: 7-9 months
Maternal outcome
Time frame: 7-9 months
Maternal outcome (HTN)
Time frame: 7-9 months
Neonatal weight at birth
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (hypoglycemia)
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (chromosomal abnormality)
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (congenital anomaly)
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (birth injury)
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (hyperbilirubinemia)
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (neonatal intensive care admission)
Time frame: Delivery of neonate to 6 weeks postpartum
Covariates (maternal obesity)
Time frame: 16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum
Covariates (maternal ethnicity)
Time frame: Enrollment (16-24 weeks gestation)
Covariates (Mother's total household income)
Time frame: enrollment 16-24 weeks gestation
Adverse events
Time frame: 7-9 months
Blood Insulin
Time frame: at 16-24 weeks gestation
Measures of insulin resistance (HOMA-IR )
Time frame: at 16-24 weeks gestation
Mean blood glucose measurement
Time frame: at 16-24 weeks gestation
Diabetes distress
Time frame: at 16-24 weeks gestation and at 34 weeks gestation
Sleep quality
Time frame: at 16-24 weeks gestation and at 34 weeks gestation
Sleep apnea
Time frame: at 16-24 weeks gestation and at 34 weeks gestation
Perceived social support
Time frame: 16-24 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Diabete Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denice Feig principal investigator
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2 and Pregnancy in Diabetic, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denice Feig, MD, MSc, FRCPC (416-586-8590, Denice.Feig@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in target range (time frame: 7-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2024.