Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis - NCT01030341-48109 (Clinical Trial 447081)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy447081.aspx
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| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48109 |
| Conditions: |
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Diabetic Gastroparesis |
| Purpose: |
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A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of
continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic
control for treatment of type 1 and type 2 diabetic patients with gastroparesis
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| Study summary: |
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This multicenter, uncontrolled, open label treatment study is to assess the safety of CGMS
in guiding insulin pump therapy for 24 weeks by measuring mild, moderate, and severe
hypoglycemic episodes in patients with type 1 and type 2 diabetes and gastroparesis. |
| Criteria: |
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Inclusion Criteria:
- Age 18 - 70 years old at registration
- Type 1 or Type 2 diabetes mellitus for at least 2 years
- Symptoms of gastroparesis (nausea, vomiting, early satiety, bloating, fullness,
discomfort) for at least 1 year prior to registration
- Gastroparesis Cardinal Symptom Index (GCSI) score of 18
- Delayed gastric emptying on gastric scintigraphy within 1 year of registration,
defined as greater than 60% retention at 2 hours or greater than 10% retention at 4
hours
- Hemoglobin A1c of at least 8.0% at registration regardless of current therapy.
Individuals already receiving diabetes therapy via an insulin pump will be eligible
for study participation if, in the opinion of the investigators, he/she may acquire
additional benefit from continuous glucose monitoring that might improve glycemic
control
- Normal upper endoscopy within 1 year of registration
- No clinical or imaging evidence of obstruction
- Successful mastering of use of CGMS during the run-in period
Exclusion Criteria:
- Prior gastric surgery including fundoplication
- Other systemic disease potentially causative of gastrointestinal symptoms
- Acute or chronic renal insufficiency with creatinine >1.5 mg/dL
- Psychiatric disease or eating disorder
- Contradiction to gastric emptying breath test such as a known allergy to egg, wheat,
or algae
- Pregnancy
- Any other condition which, in the opinion of the investigators, would impede
compliance or hinder completion of the study |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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