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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: Completed study of Type 1 Diabetes Mellitus, sponsored by DexCom.
NCT01104142 is a study of Type 1 Diabetes Mellitus that has completed, run by DexCom. The registered enrollment target is 120 participants, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01104142 record still lists
NCT01104142 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 171-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (30% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01104142's enrollment target sits among peer trials
120 27th of 112 higher than 83 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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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