Type 1 DiabetesDESTINYNCT07696780
Diabetes Management Among Women Using an AID System: a Mixed Method Study
An observational study of Type 1 Diabetes, run by DCB Research AG at 1 site in Switzerland.
Trial summary
Automated insulin delivery (AID) systems substantially improve diabetes management in people with type 1 diabetes but do not account for menstrual cycle related changes in insulin sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 69 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2024to 1 Feb 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with type 1 diabetes and menstrual cycle using AID system
Who may be able to join
- At least 18 years old
- Good knowledge of English or German
- Type 1 diabetes since >3 years
- Regular menstrual cycle (24-35 days) since >2 years
- Using one of the following AID systems: Tandem t-slim:X2 with Control-IQ; Medtronic 780G; DBLG1 (Kaleido, AkkuChek Insight); CAMAPS FX (Ypsopump, Dana); Omnipod 5; AAPS DIY; IAPS DIY; Loop DIY
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Automated insulin delivery (AID) systems substantially improve diabetes management in people with type 1 diabetes but do not account for menstrual cycle related changes in insulin sensitivity. As a result, many menstruating individuals rely on manual adjustments, such as entering fake carbohydrates, modifying insulin settings, or changing basal rates, to maintain glycemic control. This study aims to systematically characterize these manual adjustment strategies, estimate how frequently they are used across the menstrual cycle, and explore their perceived burden, effectiveness, and implications for the development of future AID algorithms that better address menstrual cycle related insulin variability.
Read the detailed description
Background Automated insulin delivery (AID) systems are expected to substantially improve diabetes management in people with type 1 diabetes but do not account for menstrual cycle related changes in insulin sensitivity, leading many menstruating individuals to rely on manual adjustments such as modifying insulin settings or entering "fake carbohydrates" to maintain glycemic control. This study will address the limited evidence in this area by systematically characterizing the range of manual adjustment strategies used across the menstrual cycle to inform the development of future AID systems.
Methods A mixed methods study design will be used, comprising an online survey followed by semi structured online focus groups with a subset of survey participants. The survey will capture self reported manual adjustment practices, while the focus groups will explore these strategies in greater depth through participant discussions to better understand the range, rationale, and variation of approaches used across the menstrual cycle.
Objectives The primary objective will be to identify and characterize manual adjustment strategies used by menstruating individuals with type 1 diabetes to compensate for menstrual cycle related changes in insulin requirements while using automated insulin delivery systems. Secondary objectives will include assessing the frequency, perceived burden and effectiveness of these strategies, their variation across the menstrual cycle, and identifying user needs to inform the development of future AID systems.
Outcomes Primary endpoints will be user reported manual adjustment strategies and perceptions of AID system use across the menstrual cycle. Secondary endpoints will include the frequency and perceived effectiveness of these strategies, user needs and preferences for AID systems, satisfaction with current system responsiveness, and the impact of menstrual cycle related adjustments on daily life.
Procedures Participants will be recruited through social media and partner networks and will complete an online REDCap survey that includes eligibility screening, informed consent, and collection of baseline characteristics, diabetes management, and menstrual cycle information. Eligible and interested participants will be invited to semi structured online focus groups (approximately five participants per group) to discuss manual adjustment strategies used during the menstrual cycle.
Statistical analysis No formal sample size calculation will be performed for the quantitative survey. Focus group data will be collected until thematic saturation is reached and will be analysed using thematic content analysis in Atlas.ti, involving transcription, coding, development of themes, and exploration of recurring patterns and relationships in manual adjustment strategies. Quantitative data will be analysed using R and Python.
- Conditions
- Type 1 Diabetes
- Keywords
- Menstrual cycle, Manual adjustments, Women's health, Mixed methods
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of manual adjustment to AID settings to manage menstrual cycle related changes in insulin requirement
Semi-structured interviews will be analyzed using reflexive thematic analysis. Participant-reported strategies used to adjust AID system behavior in response to menstrual cycle-related changes in insulin requirements will be coded into themes (e.g., fictitious carbohydrate entries, temporary glucose targets, manual boluses, profile changes). The number of participants reporting each strategy will be summarized descriptively.
Measured: One full menstrual cycle (24 - 35 days)
Secondary outcomes (3)
Frequency of manual adjustments across the menstrual cycle
Identify frequencies of manual adjustments applied by the participants
Measured: One full menstrual cycle (24 - 35 days)
Perceived burden related to manual adjustments (scale 1 - 5)
Perception of burden related to manual adjustments which are related to the menstrual cycle
Measured: One full menstrual cycle (24 - 35 days)
Self-reported assessment of effectiveness of manual adjustment strategies on glucose control
Participants' self reported perception of how well manual adjustment strategies help maintain glycemic control and support diabetes management during different phases of the menstrual cycle.
Measured: One full menstrual cycle (24 - 35 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Oct 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
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.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- DCB Research AG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martina Rothenbühler, Principal investigator, DCB Research AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696780
- Sponsor's protocol ID
- DESTINY
- Other IDs
- BASEC-ID: 2024-01267
- Acronym
- DESTINY
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data extracted from the recordings can be found in the manuscript on the study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Management Among Women Using an AID System: a Mixed Method Study
- ClinicalTrials.gov ID
- NCT07696780
- Acronym / sponsor ID
- DESTINY / DESTINY
- Conditions
- Type 1 Diabetes
- Keywords
- Menstrual cycle, Manual adjustments, Women's health, Mixed methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- DCB Research AGUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 10 Jul 2026 (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.
Automated insulin delivery (AID) systems substantially improve diabetes management in people with type 1 diabetes but do not account for menstrual cycle related changes in insulin sensitivity. As a result, many menstruating individuals rely on manual adjustments, such as entering fake carbohydrates, modifying insulin settings, or changing basal rates, to maintain glycemic control. This study aims to systematically characterize these manual adjustment strategies, estimate how frequently they are used across the menstrual cycle, and explore their perceived burden, effectiveness, and implications for the development of future AID algorithms that better address menstrual cycle related insulin variability.
Detailed description
Background Automated insulin delivery (AID) systems are expected to substantially improve diabetes management in people with type 1 diabetes but do not account for menstrual cycle related changes in insulin sensitivity, leading many menstruating individuals to rely on manual adjustments such as modifying insulin settings or entering "fake carbohydrates" to maintain glycemic control. This study will address the limited evidence in this area by systematically characterizing the range of manual adjustment strategies used across the menstrual cycle to inform the development of future AID systems.
Methods A mixed methods study design will be used, comprising an online survey followed by semi structured online focus groups with a subset of survey participants. The survey will capture self reported manual adjustment practices, while the focus groups will explore these strategies in greater depth through participant discussions to better understand the range, rationale, and variation of approaches used across the menstrual cycle.
Objectives The primary objective will be to identify and characterize manual adjustment strategies used by menstruating individuals with type 1 diabetes to compensate for menstrual cycle related changes in insulin requirements while using automated insulin delivery systems. Secondary objectives will include assessing the frequency, perceived burden and effectiveness of these strategies, their variation across the menstrual cycle, and identifying user needs to inform the development of future AID systems.
Outcomes Primary endpoints will be user reported manual adjustment strategies and perceptions of AID system use across the menstrual cycle. Secondary endpoints will include the frequency and perceived effectiveness of these strategies, user needs and preferences for AID systems, satisfaction with current system responsiveness, and the impact of menstrual cycle related adjustments on daily life.
Procedures Participants will be recruited through social media and partner networks and will complete an online REDCap survey that includes eligibility screening, informed consent, and collection of baseline characteristics, diabetes management, and menstrual cycle information. Eligible and interested participants will be invited to semi structured online focus groups (approximately five participants per group) to discuss manual adjustment strategies used during the menstrual cycle.
Statistical analysis No formal sample size calculation will be performed for the quantitative survey. Focus group data will be collected until thematic saturation is reached and will be analysed using thematic content analysis in Atlas.ti, involving transcription, coding, development of themes, and exploration of recurring patterns and relationships in manual adjustment strategies. Quantitative data will be analysed using R and Python.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with type 1 diabetes and menstrual cycle using AID system
Key inclusion criteria (5 listed)
- At least 18 years old
- Good knowledge of English or German
- Type 1 diabetes since >3 years
- Regular menstrual cycle (24-35 days) since >2 years
- Using one of the following AID systems: Tandem t-slim:X2 with Control-IQ; Medtronic 780G; DBLG1 (Kaleido, AkkuChek Insight); CAMAPS FX (Ypsopump, Dana); Omnipod 5; AAPS DIY; IAPS DIY; Loop DIY
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
Type of manual adjustment to AID settings to manage menstrual cycle related changes in insulin requirement
Time frame: One full menstrual cycle (24 - 35 days)
Semi-structured interviews will be analyzed using reflexive thematic analysis. Participant-reported strategies used to adjust AID system behavior in response to menstrual cycle-related changes in insulin requirements will be coded into themes (e.g., fictitious carbohydrate entries, temporary glucose targets, manual boluses, profile changes). The number of participants reporting each strategy will be summarized descriptively.
3 secondary outcomes
Frequency of manual adjustments across the menstrual cycle
Time frame: One full menstrual cycle (24 - 35 days)
Perceived burden related to manual adjustments (scale 1 - 5)
Time frame: One full menstrual cycle (24 - 35 days)
Self-reported assessment of effectiveness of manual adjustment strategies on glucose control
Time frame: One full menstrual cycle (24 - 35 days)
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 10 Jul 2026.
- Individual participant dataSharing planned: Undecided. All data extracted from the recordings can be found in the manuscript on the study.
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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 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, 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 5 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 10 Jul 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?
Type of manual adjustment to AID settings to manage menstrual cycle related changes in insulin requirement (time frame: One full menstrual cycle (24 - 35 days)). 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 10 Jul 2026.