Diabetes Mellitus, Type 1TIMESNCT06282055
Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1, run by DCB Research AG at 1 site in Switzerland.
Trial summary
Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Nov 2025to 15 Sep 2027
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.
Who may be able to join
- Female sex
- Between 18 and 40 years at inclusion
- Menarche at least one year prior to study inclusion
- Regular menstrual cycle (at least one menstrual cycle in the last 40 days)
- Average menstrual cycle length between 21 and 38 days
- Difference in length between consecutive menstrual cycles of at most 7 days
- Living with type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year
- Actively using an AID system for their diabetes management at least six months prior to study inclusion
Who cannot join
- Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception
- Pregnancy until two months postpartum (ongoing or planned)
- Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping
- Known Polycystic Ovary Syndrome (PCOS)
- Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs
- Individuals with work patterns involving frequent shifts between night and day work (e.g., alternating night and day shifts on a weekly or similar basis).
- Participation in an interventional study within two months preceding and during the present study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martina Rothenbühler, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
DCB Research AG
Bern, 3010
Stefanie Hossmann, MSc, 041794217376, stefanie.hossmann@dcberne.com
Martina Rothenbühler, PhD, martina.rothenbuehler@dcberne.com
About this study
Official title: Trajectories in Insulin Sensitivity Across Menstrual Cycles in Women With Type 1 Diabetes
Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- No intervention
- Keywords
- Menstrual cycle, Trajectories, Women, Insulin sensitivity, Glycaemia, Insulin need
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational prospective longitudinal data collection
| Study group | Role | What they receive |
|---|---|---|
| Women with T1D | Women living with T1D who are willing to share their diabetes management and menstrual cycle data. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify clusters in trajectories across the menstrual cycle
- Insulin sensitivity across the menstrual cycle/menstrual cycle phases (see Table 1 for definitions relevant to the clinical endpoints).
- Glycemia measures across the menstrual cycle/menstrual cycle phases:
- Percentage in Time In Range (TIR), Rime In Tight Range (TITR), Time Below Range (TBR), Time Above Range (TAR), Coefficient of Variation (CV)
- Mean glucose and mean fasted glucose
- High and Low Blood Glucose Index (HBGI and LBGI) and Glucose Management Indicator (GMI)
- Insulin administration measures across the menstrual cycle/menstrual cycle phases:
- Basal and bolus insulin dosage
- Total daily dose (TDD)
- Basal/bolus ratio
Measured: 6 months
Secondary outcomes (3)
To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness.
- Manual Insulin Adjustment Techniques:
- Frequency and classification (e.g., timing, magnitude) of manual insulin adjustments.
- Impact of adjustment techniques on glycemic outcomes.
Measured: 6 months
To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle
Identification and characterization of distinct clusters in glycemic metrics, insulin administration and insulin sensitivity representing unique patterns across distinct menstrual cycle phases (early follicular phase, late follicular phase, peri-ovulation, early luteal, mid luteal and late luteal phase)
Measured: 6 months
To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints.
Predictive Factors:
- Identification of demographic, clinical, or physiological predictors (e.g., premenstrual cycle syndrome (PMS) score or age group) that significantly correlate with primary outcomes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Nov 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DCB Research AG
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Diabetes Association, Heart and Diabetes Center North Rhine-Westphalia, University of Bristol, Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282055
- Sponsor's protocol ID
- TIMES
- Acronym
- TIMES
- Status last verified
- Dec 2025
- First submitted
- 23 Jan 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share the data but haven't specified the details yet.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories in Insulin Sensitivity Across Menstrual Cycles in Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06282055
- Acronym / sponsor ID
- TIMES / TIMES
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Menstrual cycle, Trajectories, Women, Insulin sensitivity, Glycaemia, Insulin need
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- DCB Research AGUniversity, hospital or other
- Collaborators
- The Danish Diabetes Association, Heart and Diabetes Center North Rhine-Westphalia, University of Bristol, Emory University
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 28 Feb 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.
Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with T1D | – | Other: No interventionWomen living with T1D who are willing to share their diabetes management and menstrual cycle data. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.
Key inclusion criteria (8 listed)
- Female sex
- Between 18 and 40 years at inclusion
- Menarche at least one year prior to study inclusion
- Regular menstrual cycle (at least one menstrual cycle in the last 40 days)
- Average menstrual cycle length between 21 and 38 days
Key exclusion criteria (7 listed)
- Regular hormonal intake (e.g. corticosteroids), except: insulin, stable thyroid substitution, and hormonal contraception
- Pregnancy until two months postpartum (ongoing or planned)
- Current breastfeeding (including pumping), as well as two months following complete cessation of breastfeeding and pumping
- Known Polycystic Ovary Syndrome (PCOS)
- Intake of glucocorticoid medication, agents affecting gastric emptying, oral anti-diabetic agents (Metformin) or SGLT-2 inhibitors or GLP-1-analogs
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 |
|---|---|---|
| No interventionObservational prospective longitudinal data collection | Other | Women with T1D |
Primary outcome
Identify clusters in trajectories across the menstrual cycle
Time frame: 6 months
1. Insulin sensitivity across the menstrual cycle/menstrual cycle phases (see Table 1 for definitions relevant to the clinical endpoints). 2. Glycemia measures across the menstrual cycle/menstrual cycle phases: * Percentage in Time In Range (TIR), Rime In Tight Range (TITR), Time Below Range (TBR), Time Above Range (TAR), Coefficient of Variation (CV) * Mean glucose and mean fasted glucose * High and Low Blood Glucose Index (HBGI and LBGI) and Glucose Management Indicator (GMI) 3. Insulin administration measures across the menstrual cycle/menstrual cycle phases: * Basal and bolus insulin dosage * Total daily dose (TDD) * Basal/bolus ratio
3 secondary outcomes
To quantify and classify the techniques used for manual insulin adjustments, comparing their utilization and effectiveness.
Time frame: 6 months
To quantify differences in clusters in insulin sensitivity, glycemic metrics and insulin administration across different phases of the menstrual cycle
Time frame: 6 months
To identify predictive factors that correlate individual participants and menstrual cycles with specific insulin sensitivity and clinical endpoints.
Time frame: 6 months
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 3 Dec 2025.
- Individual participant dataSharing planned: Undecided. We plan to share the data but haven't specified the details yet.
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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.
Martina Rothenbühler, PhD contact
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 Diabetes Mellitus, Type 1, run by DCB Research AG at 1 site in Switzerland.
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 8 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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 Switzerland. 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 Stefanie Hossmann, MSc (+41794217376, stefanie.hossmann@dcberne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify clusters in trajectories across the menstrual cycle (time frame: 6 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 3 Dec 2025.