Type 1 Diabetes MellitusMECHANISMNCT07004504
MEnstrual Cycle pHase ANd dIabeteS Management
An observational study of Type 1 Diabetes Mellitus, run by DCB Research AG at 1 site in Switzerland.
Trial summary
This study evaluates the impact of menstrual cycle phases on insulin sensitivity, glycaemic control, and insulin requirements in women with type 1 diabetes (T1D). It aims to quantify differences between the follicular and luteal phases using data from the Tidepool Data Platform. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 77 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Dec 2023to 29 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adults (18+) living with type 1 diabetes (T1D) who use a continuous glucose monitoring (CGM) system and either an insulin pump or a smart pen for insulin delivery. Participants must be willing to upload diabetes-related data to the Tidepool Data Platform, track and share their menstrual cycle data, and provide consent for their anonymized data to be used in research.
Who may be able to join
- People are eligible to participate in the study if they:
- are living with T1D;
- are willing to upload diabetes-related data to the Tidepool Data Platform;
- are using a continuous glucose monitoring (CGM) system;
- are using an insulin pump or a smart pen for most of their insulin delivery;
- are willing to track and share their menstrual cycle data;
- are 18 years old or older;
- give consent to share their anonymized data for research.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the impact of menstrual cycle phases on insulin sensitivity, glycaemic control, and insulin requirements in women with type 1 diabetes (T1D). It aims to quantify differences between the follicular and luteal phases using data from the Tidepool Data Platform. Key endpoints include modelled insulin sensitivity, mean glucose, Time in Range (TIR), and total insulin dose.
Secondary objectives include assessing phase-specific variability in the endpoints and differences between participants.
Read more
The study follows a decentralized, anonymized data collection approach, with participants using continuous glucose monitors (CGMs) and insulin pumps or smart pens. Glycaemic outcomes and insulin requirements will be compared across menstrual cycle phases using linear mixed-effects models to account for repeated measures within individuals. Cycle phase-specific variation in insulin sensitivity will be quantified using a hierarchical Bayesian state-space model, which estimates a latent insulin sensitivity parameter from CGM time series data while accounting for measurement noise and temporal dynamics.
The findings are expected to improve understanding of glycaemic dynamics across the menstrual cycle and inform future diabetes management strategies.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Insulin sensitivity, Menstrual cycle, Diabetes management
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | The study cohort consists of women with type 1 diabetes (T1D) who use continuous glucose monitoring (CGM) and insulin pumps to manage their diabetes. Participants will anonymously upload their diabetes management data, along with self-reported menstrual cycle information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity quantified by using a hierarchical Bayesian state-space model that estimates a latent insulin sensitivity parameter from CGM time series data.
Measured: Between 1 and 12 months
Secondary outcomes (7)
Mean glucose
Mean daily glucose based on CGM data
Measured: Between 1 and 12 months
Time in range (TIR)
Mean daily TIR based on CGM data
Measured: Between 1 and 12 months
Time above range (TAR)
Mean daily TAR based on CGM data
Measured: Between 1 and 12 months
Time belwo range (TBR)
Mean daily TBR based on CGM data
Measured: Between 1 and 12 months
Total daily insulin
Mean daily total insulin based on insulin pump data
Measured: Between 1 and 12 months
Total basal insulin
Mean daily total basal insulin based on insulin pump data
Measured: Between 1 and 12 months
Total bolus insulin
Mean daily total bolus insulin based on insulin pump data
Measured: Between 1 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start14 Dec 2023
- Primary completion29 Dec 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- DCB Research AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martina Rothenbühler, PhD, Principal investigator, DCB Research AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004504
- Sponsor's protocol ID
- MECHANISM
- Acronym
- MECHANISM
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schiavon M, Dalla Man C, Kudva YC, Basu A, Cobelli C. Quantitative estimation of insulin sensitivity in type 1 diabetic subjects wearing a sensor-augmented insulin pump. Diabetes Care. 2014;37(5):1216-23. doi: 10.2337/dc13-1120. Epub 2013 Dec 6.
PubMed 24319120
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEnstrual Cycle pHase ANd dIabeteS Management
- ClinicalTrials.gov ID
- NCT07004504
- Acronym / sponsor ID
- MECHANISM / MECHANISM
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Insulin sensitivity, Menstrual cycle, Diabetes management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- DCB Research AGUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 4 Jun 2025 (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 study evaluates the impact of menstrual cycle phases on insulin sensitivity, glycaemic control, and insulin requirements in women with type 1 diabetes (T1D). It aims to quantify differences between the follicular and luteal phases using data from the Tidepool Data Platform. Key endpoints include modelled insulin sensitivity, mean glucose, Time in Range (TIR), and total insulin dose.
Secondary objectives include assessing phase-specific variability in the endpoints and differences between participants.
The study follows a decentralized, anonymized data collection approach, with participants using continuous glucose monitors (CGMs) and insulin pumps or smart pens. Glycaemic outcomes and insulin requirements will be compared across menstrual cycle phases using linear mixed-effects models to account for repeated measures within individuals. Cycle phase-specific variation in insulin sensitivity will be quantified using a hierarchical Bayesian state-space model, which estimates a latent insulin sensitivity parameter from CGM time series data while accounting for measurement noise and temporal dynamics.
The findings are expected to improve understanding of glycaemic dynamics across the menstrual cycle and inform future diabetes management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | –The study cohort consists of women with type 1 diabetes (T1D) who use continuous glucose monitoring (CGM) and insulin pumps to manage their diabetes. Participants will anonymously upload their diabetes management data, along with self-reported menstrual cycle information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adults (18+) living with type 1 diabetes (T1D) who use a continuous glucose monitoring (CGM) system and either an insulin pump or a smart pen for insulin delivery. Participants must be willing to upload diabetes-related data to the Tidepool Data Platform, track and share their menstrual cycle data, and provide consent for their anonymized data to be used in research.
Key inclusion criteria (8 listed)
- are living with T1D;
- are willing to upload diabetes-related data to the Tidepool Data Platform;
- are using a continuous glucose monitoring (CGM) system;
- are using an insulin pump or a smart pen for most of their insulin delivery;
- are willing to track and share their menstrual cycle data;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Insulin sensitivity
Time frame: Between 1 and 12 months
Insulin sensitivity quantified by using a hierarchical Bayesian state-space model that estimates a latent insulin sensitivity parameter from CGM time series data.
7 secondary outcomes
Mean glucose
Time frame: Between 1 and 12 months
Time in range (TIR)
Time frame: Between 1 and 12 months
Time above range (TAR)
Time frame: Between 1 and 12 months
Time belwo range (TBR)
Time frame: Between 1 and 12 months
Total daily insulin
Time frame: Between 1 and 12 months
Total basal insulin
Time frame: Between 1 and 12 months
Total bolus insulin
Time frame: Between 1 and 12 months
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 25 Mar 2026.
- Background: PubMed 24319120Schiavon M, Dalla Man C, Kudva YC, Basu A, Cobelli C. Quantitative estimation of insulin sensitivity in type 1 diabetic subjects wearing a sensor-augmented insulin pump. Diabetes Care. 2014;37(5):1216-23. doi: 10.2337/dc13-1120. Epub 2013 Dec 6.
- 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.
Martina Rothenbühler, PhD principal investigator
DCB Research AG
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 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 0 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 25 Mar 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 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?
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 (time frame: Between 1 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004504, which also lists 1 linked publication.
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 25 Mar 2026.