NCT04163874 study context · version 1

Diabetes · Not applicable

Pramlintide: automated delivery and meal announcements

What was tested?

Automated insulin plus pramlintide with simpler meal announcements compared with automated insulin plus placebo and carbohydrate counting in a crossover study. ↗

Registered primary question: Two primary comparisons over 12-day assessment periods: time with glucose in the target range and the Emotional Burden score from the Diabetes Distress Scale. ↗

What the reviewed report found

Journal year 2024 · Article summary reviewed 2026-09-15

The insulin-and-pramlintide system with simple meal announcements met the prespecified glucose-control noninferiority comparison but did not improve emotional burden. Gastrointestinal symptoms occurred more often with pramlintide; no serious adverse events occurred.^↗

Keep in context: The comparison changes both the drug combination and the meal-announcement approach. The publication describes 32 enrolled and 30 completing analysis; the registry lists 36 enrolled. Glucose noninferiority does not establish reduced emotional burden. ↗↗

Participants, design, limitations and sources

Registry snapshot

Registry enrollment: 36 · reported actual
Registry status: Completed
Allocation and masking: Randomized · Triple
Design: Crossover
Eligible ages: 12 Years; maximum not specified
Registry results: Not posted in this snapshot

Registry source ↗ · Updated 2022-10-10; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.

Experimental automated delivery

Design in the report: Randomized crossover comparison of three automated-delivery approaches, each studied for 14 days.^↗
Participants in the report: 32 participants enrolled; 30 completing all interventions were analyzed, including 15 adults and 15 adolescents.^↗
Limitations: The small, short crossover trial excluded noncompleters from the primary analysis. It evaluates a combined device-and-drug approach and cannot establish longer-term safety or a broader approved indication.^↗

This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →

How the study identity and sources were checked

Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.

Registry

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas ↗
Protocol identifier: 2020-5712. Sponsor: McGill University.
Retrieved 2026-09-20; SHA-256 4861de825a2834dbfb7c9ab1ccccf6d7bb8c32dc8c01a95322b1af41b68169b1.

PMID 38906614

Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada. ↗

Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.

Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 38906614. SHA-256 41d8294d068021181ac91c0e24653b6ad9cd594c0d216c1ab732b5e6f7334c8a.

Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 41d8294d068021181ac91c0e24653b6ad9cd594c0d216c1ab732b5e6f7334c8a.