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Trial · Observational

CompletedPhase not statedRegistry data

Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

NCTNCT00569907 (opens ClinicalTrials.gov in a new tab)Other id03520-06-C
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Exenatide (exendin-4), does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase not stated
Enrollment
18 participants (actual)
Sponsor
HealthPartners Institute · Other
Design
Not stated
Countries
1 country

United States

Start
Jan 2007
Primary completion
May 2009
Completion
May 2009
First posted
10 Dec 2007 (estimated)
Last update posted
26 Nov 2015 (estimated)
Conditions
Diabetes Mellitus Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph –

    Observational Study of Interstitial Glucose Monitoring With Continuous Glucose Monitoring to Track Patients Treated With Exenatide

    NCT00569907

    Jan 2007 to May 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Approximately 30 adults will participate in this study at the International Diabetes Center (IDC). The IDC is the only site conducting this study. Length of participation can range from two to three months which will include four to seven clinic visits. The purpose of this study is to use a Continuous Glucose Monitoring (CGM) system to determine the characteristics of glucose control and patterns of food intake before exenatide is started, during the start and adjustment of exenatide and during exenatide treatment. The long-term purpose of this study is to determine to what extent continuous glucose monitoring improves or alters clinical decision making for patients treated with exenatide. And, the study will also compare CGM to conventional self-monitored blood glucose methods. The study will also compare subjects' changes, if any, in nutrient intake such as energy, protein, fat and carbohydrate during the course of the study through interpretation/analysis of self-reported food intake.

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2005

9 results

Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes.

DeFronzo et al. 2005Diabetes carecited by 1,048

PMID 15855572DOI 10.2337/diacare.28.5.1092PUB-15855572

Full text at the publisher9 results
Publisher pageSee results (9)

Indexing hint: Randomized controlled trial · 2004

8 results

Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes.

Buse et al. 2004Diabetes carecited by 890

PMID 15504997DOI 10.2337/diacare.27.11.2628PUB-15504997

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female (if of child-bearing age must practice appropriate birth control such as tubal ligation, oral contraceptives, abstinence or vasectomized partner during the duration of the study) * Previously diagnosed with type 2 diabetes * Age 21 and older * Treated with metformin, a sulfonylurea, a thiazolidinedione, a combination or metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione (approved FDA indications) * HbA1c 7.1-11%, unless subject has been using exenatide prior to study; in that case, there is no restriction on HbA1c level. * Willing to give informed consent * Motivated and capable of following the protocol and instructions provided by the healthcare professional * Available for the study on the scheduled visit days * Access to telephone communications Exclusion Criteria: * Under 21 years of age * Pregnancy * Creatinine clearance \<30 ml/min (using MDRD formula) * Known gastrointestinal disease * Without diabetes or known type 1 diabetes * Unable to follow the study protocol * Unable to read and write in English * Allergy to adhesives * Any concomitant medical condition that would likely affect the evaluation of CGM device performance as determined by the investigator such as dermatological conditions or myxedema.

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