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NCT01887691 · ClinicalTrials.gov registry record · Phase 1

Sleep Effectiveness and Insulin and Glucose Homeostasis

A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.

Terminated
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01887691: Clinical Trial Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.

NCT01887691 is a Phase 1 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01887691, a Phase 1 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.

TERMINATED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

The purpose of this study is to examine the influence of sleep effectiveness on glucose and insulin metabolism in health and disease (prediabetes and type two diabetes). We will monitor sleep effectiveness using the sleep spectrogram, obtain serial nocturnal blood glucose and insulin measurements, and assess the impact of pharmacologic enhancement \[using eszopiclone (Lunesta), a medication that promotes stable sleep)\] on glucose and insulin homeostasis. We hypothesize that 1: Effective sleep is associated with enhanced insulin sensitivity, relative to ineffective sleep states, and 2: Enhancing sleep effectiveness using eszopiclone (Lunesta) improves 24-hour glucose metabolism in prediabetics and diabetics compared to baseline.

Primary Outcome

continuous glucose monitoring (CGM) results - mean daytime, post prandial and nocturnal glucose between baseline and after 1 week of eszopiclone

Interventions

  • DRUG eszopiclone

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-10
Est. Completion 2019-12
Phase Phase 1

Why NCT01887691 stopped before completion

NCT01887691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which eszopiclone is the first listed.

NCT01887691 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01887691 about?

NCT01887691 is a clinical study titled "Sleep Effectiveness and Insulin and Glucose Homeostasis". The purpose of this study is to examine the influence of sleep effectiveness on glucose and insulin metabolism in health and disease (prediabetes and type two diabetes). We will monitor sleep effectiveness using the sleep spectrogram, obtain serial nocturnal blood glucose and insulin measurements, ...

What is the current status of trial NCT01887691?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-10. Estimated completion is 2019-12.

What interventions are being tested in trial NCT01887691?

The interventions under investigation include: eszopiclone (DRUG).

Who is sponsoring clinical trial NCT01887691?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01887691's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01887691, the US trial registry maintained by the National Library of Medicine. NCT01887691 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.