An interventional study of Personalized modifications to treatment to address menstrual cycle effects on glycemia in Type 1 Diabetes, Hypoglycemia and Hyperglycaemia Due to Type 1 Diabetes Mellitus, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
Among 58 studies in Diabetes Mellitus, Type 1 by University of Colorado, Denver — 10 open to participants now, 13 under way, 1 of them phase 3. Diabetes Mellitus, Type 1 · University of Colorado, Denver.
Among the 58 studies in Diabetes Mellitus, Type 1 by University of Colorado, Denver, this one is the 5th largest by planned enrollment of the 44 interventional ones, is one of 3 that started in 2024, is one of 25 with no phase, reaches primary completion later than 8 of the 12 other live ones, and was the 52nd registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →10 of the 58 studies in Diabetes Mellitus, Type 1 by University of Colorado, Denver are open now, in 1 country. Each count lists the studies.
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →58 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 3 started in 2024.
Median enrollment 44 across the 44 interventional studies, 85 across the 14 observational. Of the 43 that completed or were terminated, 19 (44%) have results posted.
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
6 of the studies in Diabetes Mellitus, Type 1 by University of Colorado, Denver that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05819138Phase 3University of Colorado, DenverType 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes | 2027-10-01 |
| NCT07494188University of Colorado, DenverSleep Screening and Intervention for Adolescents With Type 1 Diabetes in a Clinical Diabetes Center | 2026-12-01 |
| NCT07011147University of Colorado, DenverPrimary Care Pragmatic, Real World Experience for Automated Insulin Delivery | 2027-06-30 |
| NCT05319990University of Colorado, DenverPathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study) | 2027-06-30 |
| NCT07720388University of Colorado, DenverSupporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative | 2027-07 |
Among the 58 studies in Diabetes Mellitus, Type 1 by University of Colorado, Denver, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Personalized modifications to treatment to address menstrual cycle effects on glycemia
In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider
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.
Glucose time in range
time spent with glucose 70-180mg/dL on continuous glucose monitor
Time frame: 3 months during randomization to intervention or standard care
Glucose standard deviation
standard deviation (mg/dL) of glucose on continuous glucose monitor
Time frame: 3 months during randomization to intervention or standard care
Mean glucose (mg/dL) pre-exercise
Mean glucose from continuous glucose monitor in response to 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
Mean glucose from continuous glucose monitor in response to exercise
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
Mean glucose from continuous glucose monitor in response to 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
standard deviation (mg/dL) of glucose on continuous glucose monitor
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
standard deviation (mg/dL) of glucose on continuous glucose monitor
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)
Plan to share: Yes — There will be a steering committee that will review requests for individual participant data through an ancillary study and paper proposal process
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Data will become available within 12 months from the end of the data collection
Access criteria: Researchers wishing to access IPD will be requested to complete an application and a data transfer agreement
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Oct 2027, 43 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 43 months is above that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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