Type 1 Diabetes MellitusNCT04665999
Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial summary
This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 10 Mar 2022
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Females between the ages of 18 and 40 with no signs of menopause either free cycling or taking a monophasic contraception.
Who may be able to join
- Type 1 diabetes for at least 12 months
- Use of glucose sensor in the last 6 months
- Use of insulin pump in the last 6 months
- Age ≥18 to ≤40 years
- HbA1c ≤8.5% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately 200 mg/dL or less
- Absence of perimenopausal/menopausal symptoms
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- Willingness to keep track of beginning of menstrual cycle
- Willingness to keep track of ingested carbohydrates
- Willingness to not become pregnant during study participation
- Regularly menstruating (at least every month with no missed cycles)
- Only free-cycling participants: willingness to use ovulation kits to confirm ovulation
- Only participants under oral contraceptive therapy: use of monophasic pill, with 3 weeks of active pill and 1 week of placebo
- Willingness to use the study Dexcom G6 during the study
- Participants must have Internet access and a computer system that meets the requirements for uploading the study equipment
Who cannot join
- Pregnancy
- Hormonal birth control therapy except monophasic pill contraceptive
- Polycystic ovary syndrome (PCOS) diagnosis
- Current use of steroids
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas, metformin)
- Uncontrolled thyroid disease
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- Active fertility treatment
- Concomitant disease or condition that may compromise patient safety or ability to follow the protocol including: planned or current dialysis treatment; moderate to advanced nephropathy; known or suspected allergy to medical grade adhesives.
- Severe hypoglycemia or diabetes ketoacidosis (DKA) in the previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. All study appointments may be completed virtually.
Read the detailed description
Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (CGM) in order to collect 3 full menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants will include free-cycling females and females following oral contraceptive therapy. Study CGMs and activity trackers will be provided for the entire data collection period. During data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. The Clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Continuous Glucose Monitor
- Keywords
- Menstrual Cycle, Continuous Glucose Monitor (CGM), Oral contraceptives, Free cycling
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Data collection only
| Study group | Role | What they receive |
|---|---|---|
| Free-cycling females | Continuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial. Receives: Device: Continuous Glucose Monitor | |
| Females taking Monophasic contraception | Continuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial. Receives: Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics.
Primary Variable
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Jan 2021
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Chiara Fabris, PhD, University of Virginia
- Investigators
- Chiara Fabris, PhD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665999
- Sponsor's protocol ID
- 190046
- Status last verified
- Mar 2022
- First submitted
- 7 Dec 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04665999
- Acronym / sponsor ID
- 190046
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Menstrual Cycle, Continuous Glucose Monitor (CGM), Oral contraceptives, Free cycling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 14 Dec 2020 (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.
This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. All study appointments may be completed virtually.
Detailed description
Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (CGM) in order to collect 3 full menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants will include free-cycling females and females following oral contraceptive therapy. Study CGMs and activity trackers will be provided for the entire data collection period. During data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. The Clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free-cycling females | – | Device: Continuous Glucose MonitorContinuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial. |
| Females taking Monophasic contraception | – | Device: Continuous Glucose MonitorContinuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females between the ages of 18 and 40 with no signs of menopause either free cycling or taking a monophasic contraception.
Key inclusion criteria (14 listed)
- Type 1 diabetes for at least 12 months
- Use of glucose sensor in the last 6 months
- Use of insulin pump in the last 6 months
- Age ≥18 to ≤40 years
- HbA1c ≤8.5% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately 200 mg/dL or less
Key exclusion criteria (9 listed)
- Pregnancy
- Hormonal birth control therapy except monophasic pill contraceptive
- Polycystic ovary syndrome (PCOS) diagnosis
- Current use of steroids
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas, metformin)
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 |
|---|---|---|
| Continuous Glucose MonitorData collection only | Device | Females taking Monophasic contraception, Free-cycling females |
Primary outcome
Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics.
Time frame: 3 months
Primary Variable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Chiara Fabris, PhD principal investigator
University of Virginia Center for Diabetes Technology
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 Type 1 Diabetes Mellitus, run by University of Virginia at 1 site 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 14 inclusion and 9 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 6 Apr 2022. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics. (time frame: 3 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 6 Apr 2022.