Type 1 DiabetesMERITNCT06297980
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
A study testing Personalized modifications to treatment to address menstrual cycle effects on glycemia in people with Type 1 Diabetes and Hypoglycemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia, Hyperglycaemia Due to Type 1 Diabetes Mellitus
- What is being tested?
- Personalized modifications to treatment to address menstrual cycle effects on glycemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18-45 who have had type 1 diabetes for at least 12 months
- Premenopausal with either menstrual cycles or currently using oral contraceptives
Who cannot join
- Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
JANET K SNELL-BERGEON, PhD, 3037246762, Janet.Snell-Bergeon@cuanschutz.edu
Catherine Chartier-Logan, MPH, 3037247505, Catherine.Chartier-Logan@cuanschutz.edu
About this study
The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.
Read the detailed description
The overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing, through implementing the following specific aims:
Specific Aim 1: Using CGM, examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability, to identify personalized patterns of glycemic control across the menstrual cycle phase, and to test glycemic responses to acute bouts of aerobic, interval and resistance training.
Specific Aim 2: Using the data from the observational period, examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D
Specific Aim 3: Test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group. We will also examine responses to daily activity, planned exercise activities, and acute bouts of aerobic, interval and resistance exercise.
- Conditions
- Type 1 Diabetes, Hypoglycemia, Hyperglycaemia Due to Type 1 Diabetes Mellitus, Menstruation Disturbances
- Being tested
- Personalized modifications to treatment to address menstrual cycle effects on glycemia
- Keywords
- type 1 diabetes, menstrual cycle, exercise, hypoglycemia, hyperglycemia, glucose control
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Menstruation Disturbances, Motor Activity, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized modifications to treatment to address menstrual cycle effects on glycemiaOther
The study physician will examine glucose patterns measured using continuous glucose monitoring over a 3 month observational period to identify hypo- or hyperglycemia related to menstrual cycle phase or exercise, and will provide changes to insulin basal or bolus rates, carbohydrate ratios, post-exercise food intake or use of sleep mode on automated insulin delivery systems.
| Study group | Role | What they receive |
|---|---|---|
| Personalized treatment | Experimental | We will test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase, based on the three months of observational data collected. Receives: Other: Personalized modifications to treatment to address menstrual cycle effects on glycemia |
| Standard Care | No intervention | In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose time in range
time spent with glucose 70-180mg/dL on continuous glucose monitor
Measured: 3 months during randomization to intervention or standard care
Glucose standard deviation
standard deviation (mg/dL) of glucose on continuous glucose monitor
Measured: 3 months during randomization to intervention or standard care
Secondary outcomes (5)
Mean glucose (mg/dL) pre-exercise
Mean glucose from continuous glucose monitor in response to exercise
Measured: mean glucosewithin 5 minutes of beginning planned exercise bouts based on start time reported by study participant and/or accelerometer data
Mean glucose (mg/dL) while exercising
Mean glucose from continuous glucose monitor in response to exercise
Measured: mean glucose measured every 5 minutes while actively exercising (between exercise start and end times as reported by study participant or based on accelerometer data, from a minimum of 5 minutes to up to 480 minutes)
Mean glucose (mg/dL) over 24 hours after exercise
Mean glucose from continuous glucose monitor in response to exercise
Measured: mean glucose during the 24 hours after beginning planned exercise bouts (from participant reported or acceleromater data based start of exercise to 24 hours later)
Glucose standard deviation
standard deviation (mg/dL) of glucose on continuous glucose monitor
Measured: glucose standard deviation during the follicular (starting day one of the menstrual period as self-reported by study participant through a positive home test for ovulation by participant, or for a maximum of 30 days if no positive ovulation test)
Glucose standard deviation
standard deviation (mg/dL) of glucose on continuous glucose monitor
Measured: glucose standard deviation during the luteal menstrual cycle phase (starting from the day of a positive home ovulation test to the start of the next period reported by participant, for a maximum of 30 days if no next period begins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start24 Mar 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- JANET K SNELL-BERGEON, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297980
- Sponsor's protocol ID
- 23-1513
- Acronym
- MERIT
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There will be a steering committee that will review requests for individual participant data through an ancillary study and paper proposal process
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06297980
- Acronym / sponsor ID
- MERIT / 23-1513
- Conditions
- Type 1 Diabetes, Hypoglycemia, Hyperglycaemia Due to Type 1 Diabetes Mellitus, Menstruation Disturbances
- Keywords
- type 1 diabetes, menstrual cycle, exercise, hypoglycemia, hyperglycemia, glucose control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Mar 2024 (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.
The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.
Detailed description
The overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing, through implementing the following specific aims:
Specific Aim 1: Using CGM, examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability, to identify personalized patterns of glycemic control across the menstrual cycle phase, and to test glycemic responses to acute bouts of aerobic, interval and resistance training.
Specific Aim 2: Using the data from the observational period, examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D
Specific Aim 3: Test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group. We will also examine responses to daily activity, planned exercise activities, and acute bouts of aerobic, interval and resistance exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period.
| Arm | Type | Receives |
|---|---|---|
| Personalized treatment | Experimental | Other: Personalized modifications to treatment to address menstrual cycle effects on glycemiaWe will test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase, based on the three months of observational data collected. |
| Standard Care | No intervention | –In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women 18-45 who have had type 1 diabetes for at least 12 months
- Premenopausal with either menstrual cycles or currently using oral contraceptives
Key exclusion criteria (1 listed)
- Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy
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 |
|---|---|---|
| Personalized modifications to treatment to address menstrual cycle effects on glycemiaThe study physician will examine glucose patterns measured using continuous glucose monitoring over a 3 month observational period to identify hypo- or hyperglycemia related to menstrual cycle phase or exercise, and will provide changes to insulin basal or bolus rates, carbohydrate ratios, post-exercise food intake or use of sleep mode on automated insulin delivery systems. | Other | Personalized treatment |
Primary outcome
Glucose time in range
Time frame: 3 months during randomization to intervention or standard care
time spent with glucose 70-180mg/dL on continuous glucose monitor
Glucose standard deviation
Time frame: 3 months during randomization to intervention or standard care
standard deviation (mg/dL) of glucose on continuous glucose monitor
5 secondary outcomes
Mean glucose (mg/dL) pre-exercise
Time frame: mean glucosewithin 5 minutes of beginning planned exercise bouts based on start time reported by study participant and/or accelerometer data
Mean glucose (mg/dL) while exercising
Time frame: mean glucose measured every 5 minutes while actively exercising (between exercise start and end times as reported by study participant or based on accelerometer data, from a minimum of 5 minutes to up to 480 minutes)
Mean glucose (mg/dL) over 24 hours after exercise
Time frame: mean glucose during the 24 hours after beginning planned exercise bouts (from participant reported or acceleromater data based start of exercise to 24 hours later)
Glucose standard deviation
Time frame: glucose standard deviation during the follicular (starting day one of the menstrual period as self-reported by study participant through a positive home test for ovulation by participant, or for a maximum of 30 days if no positive ovulation test)
Glucose standard deviation
Time frame: glucose standard deviation during the luteal menstrual cycle phase (starting from the day of a positive home ovulation test to the start of the next period reported by participant, for a maximum of 30 days if no next period begins)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. There will be a steering committee that will review requests for individual participant data through an ancillary study and paper proposal process
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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.
JANET K SNELL-BERGEON, PhD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized modifications to treatment to address menstrual cycle effects on glycemia in people with Type 1 Diabetes and Hypoglycemia, run by University of Colorado, Denver 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JANET K SNELL-BERGEON, PhD, MPH (3037246762, Janet.Snell-Bergeon@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose time in range (time frame: 3 months during randomization to intervention or standard care). The study lists 2 primary outcomes in all. 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 16 Jun 2026.