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NCT03260868 · ClinicalTrials.gov registry record · Phase 4

Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)

A Phase 4 study, sponsored by Sanofi.

Terminated
Registry status
Phase 4
Development phase
15
Enrollment target

NCT03260868: Clinical Trial Phase 4 study, sponsored by Sanofi.

NCT03260868 is a Phase 4 study that was terminated before completion, run by Sanofi. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03260868, a Phase 4 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 4
Development phase
15 participants
Enrollment target

Study Summary

Primary Objective: To evaluate the effect of virtual approach via novel technologies versus traditional study conduct on glycemic control in terms of glycated hemoglobin (HbA1c). Secondary Objective: To evaluate the appropriate utilization of virtual approach via novel technologies during the study and to assess the effect of the virtual versus traditional study conduct on multiple outcomes in terms of study methodology and diabetes management.

Primary Outcome

Change in HbA1c was calculated by subtracting baseline value from Week 24 value.

Interventions

  • DRUG Insulin glargine, 300 units per milliliter (U/mL)
  • DRUG Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2017-09-19
Est. Completion 2018-11-22
Phase Phase 4
Sanofi

713 total trials

Why NCT03260868 stopped before completion

NCT03260868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Insulin glargine, 300 units per milliliter (U/mL) is the first listed.

NCT03260868 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03260868 about?

NCT03260868 is a clinical study titled "Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)". Primary Objective: To evaluate the effect of virtual approach via novel technologies versus traditional study conduct on glycemic control in terms of glycated hemoglobin (HbA1c). Secondary Objective: To evaluate the appropriate utilization of virtual approach via novel technologies during the stu...

What is the current status of trial NCT03260868?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2017-09-19. Estimated completion is 2018-11-22.

What interventions are being tested in trial NCT03260868?

The interventions under investigation include: Insulin glargine, 300 units per milliliter (U/mL) (DRUG), Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra) (DRUG).

Who is sponsoring clinical trial NCT03260868?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03260868's enrollment target sits among peer trials

15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT03260868, the US trial registry maintained by the National Library of Medicine. NCT03260868 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.