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NCT01104142 · ClinicalTrials.gov registry record
Efficacy of Continuous Glucose Monitoring in Subjects With Type 1 Diabetes Mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) Therapy
A clinical trial of Type 1 Diabetes Mellitus, sponsored by DexCom.
- Completed
- Registry status
- 120
- Enrollment target
- 1
- Study location
NCT01104142 is a study of Type 1 Diabetes Mellitus that has completed, run by DexCom. The registered enrollment target is 120 participants, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01104142, a study of Type 1 Diabetes Mellitus, has completed, sponsored by DexCom.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effectiveness of the Continuous Glucose Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic control when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes mellitus on MDI or CSII therapy. The primary objective of this study is to demonstrate no statistically significant differences between MDI and CSII subjects in terms of A1C change at 6 months as compared to baseline. A secondary objective is to evaluate time spent outside of the euglycemic region (70 to 180 mg/dL) from the baseline (blinded month) to the conclusion of 6 month follow-up. Safety data of the SEVEN PLUS System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.
Conditions Studied
Interventions
- DEVICE CGM
Study Locations (1)
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2009-04 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01104142
The ClinicalTrials.gov registry entry for NCT01104142 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (14% lower). The listed sponsor is DexCom, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which CGM is the first listed.
NCT01104142 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT01104142 about?
NCT01104142 is a clinical study titled "Efficacy of Continuous Glucose Monitoring in Subjects With Type 1 Diabetes Mellitus on Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) Therapy". The purpose of this study is to evaluate the effectiveness of the Continuous Glucose Monitoring System (DexCom™ SEVEN PLUS®) and to evaluate the impact of CGM on glycemic control when worn for up to 6-months by subjects 18 to 70 years-old with Type 1 diabetes mellitus on MDI or CSII therapy. The pr...
What is the current status of trial NCT01104142?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2009-04.
What conditions does trial NCT01104142 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT01104142?
The interventions under investigation include: CGM (DEVICE).
Who is sponsoring clinical trial NCT01104142?
This trial is sponsored by DexCom, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01104142 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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