Research Signal – Source date 2026-05-18
Could adding melatonin to insulin help teenagers with type 1 diabetes manage blood sugar—and perhaps function better day to day? Melatonin is a hormone associated with sleep. A ClinicalTrials.gov record, NCT07592442, describes a completed randomized trial designed to test that possibility in adolescents aged 12 to 18. Completion makes the study an important source of a research question, but it is not a treatment result: the supplied registry record lists no posted results.
The study began on 24 November 2024. Its primary completion date was 24 November 2025, and its recorded completion date was 24 January 2026. Those dates describe when the trial took place, not when findings became available or were first posted. This account is anchored to 18 May 2026; that date does not establish the registry’s first posting date or a results-publication milestone.
The question behind adding melatonin
The trial asks whether melatonin might add something to an existing insulin regimen. It does not test melatonin as a replacement for insulin. The registry describes two groups of adolescents with type 1 diabetes, with insulin therapy continuing in both groups while the added treatment differs.
That makes the practical question relatively specific. If the melatonin group later showed a better glucose pattern or different cognitive measurements than the placebo group, the comparison would point to the added supplement as a possible contributor. Without that group-to-group result, the rationale remains a hypothesis. Associations between melatonin, sleep and glucose biology do not establish that supplementation improves diabetes management in teenagers.
How the comparison was set up
The actual enrollment was 70 adolescents, divided into two equal groups of 35. The study is recorded as randomized and parallel-group. One group received an oral 3-milligram melatonin tablet once daily alongside insulin; the other received placebo alongside insulin.
Random assignment gives the trial a structure for comparing the two add-on approaches over the same six-month period. It also clarifies what the study is not designed to show from its basic description: it cannot, by design alone, tell readers whether the melatonin group spent more time in its glucose target range, experienced better everyday cognitive functioning or had fewer depressive symptoms.
Glucose was the main test, while cognition and mood were separate measures
The primary registered outcome is change from baseline in time in range after six months, measured with continuous glucose monitoring. Time in range describes how much of the monitoring period glucose readings remain within a defined target range. It is therefore a measure of glucose patterns over time, rather than a simple statement about one blood-glucose reading.
The study also registered secondary assessments of executive-function problems and depressive symptoms. Executive functioning refers to mental skills involved in organizing, regulating and carrying out activities. Parents completed the Barkley Deficits in Executive Functioning Scale for Children and Adolescents, while the methods also describe Arabic editions of the Wechsler Intelligence Scale for Children and the nine-item Patient Health Questionnaire. The PHQ-9 is scored from 0 to 27, with higher scores indicating more depressive symptoms; the parent-rated executive-function scale is scored from 70 to 280, with higher scores indicating more problems. Assessments were made at baseline, three months and six months, alongside measures including HbA1c and fasting lipids.
The study title and rationale include sleep quality, but the supplied outcome details do not authorize a claim that a dedicated sleep measure was reported or that sleep improved. That is a boundary on the conclusions available here, not a finding that sleep was absent from the actual study.
What the completed record still leaves unanswered
The registry’s completed status means the planned study period has ended. It does not reveal whether one group improved more than the other, the size of any difference, or whether any potential benefit was balanced by harms. The supplied snapshot explicitly says results have not been posted there, so the registered design and endpoint definitions are the evidence available for this account—not estimates of effectiveness.
The material also does not authorize conclusions about masking, adherence, attrition or adverse-event findings. Those details may matter greatly when judging a small adolescent trial, but they cannot be filled in from the fact that the study was randomized, placebo-comparator and completed. The population itself is narrow: adolescents aged 12 to 18 with type 1 diabetes. Nothing in this record establishes reduced insulin needs, safe self-directed supplementation, dementia prevention or relevance to other age groups.
What this could mean for adolescent diabetes care
A favorable comparison could give adolescents and their diabetes teams an additional treatment option alongside insulin, potentially helping them spend more time within their glucose target range. That possibility depends on a clear treatment difference, acceptable safety and validation beyond this single 70-participant study. Better everyday cognitive functioning is a separate potential benefit and would need its own favorable comparative evidence. Until those results and checks are available, the record marks a testable clinical question rather than a recommendation to use melatonin.
Key Sources
- Primary source: Effect of Melatonin Supplementation on Excecutive Functions, Sleep Quality and Glycemic Metrics Among Adolescents With Type 1 Diabetes Mellitus
Government or Regulator · Clinical Trial · 2026-05-18
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