Diabetes Management Among Women Using an AID System: a Mixed Method Study

NCT07696780 | Completed

• 2 other identifiers: DESTINYBASEC-ID: 2024-01267
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 1 Diabetes

Keywords

Menstrual cycle; Manual adjustments; Women's health; Mixed methods

Outcome Measures

Primary Outcomes (1)

• 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.

  One full menstrual cycle (24 - 35 days)

Secondary Outcomes (3)

• Frequency of manual adjustments across the menstrual cycle

  One full menstrual cycle (24 - 35 days)

• Perceived burden related to manual adjustments (scale 1 - 5)

  One full menstrual cycle (24 - 35 days)

• Self-reported assessment of effectiveness of manual adjustment strategies on glucose control

  One full menstrual cycle (24 - 35 days)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: People with a menstrual cycle
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with type 1 diabetes and menstrual cycle using AID system

You may qualify if:

• 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

Sponsors & Collaborators

• DCB Research AG: lead

Study Sites (1)

DCB Research AG

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Martina Rothenbühler

  DCB Research AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 10, 2026
• Study Start: October 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CH (1)