Clinical trial NCT00211536: Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
Official title: A Randomized, Active Control, Multi-Center Study Comparing the Effect of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration on Glycemic Control and the Frequency of Severe Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: Diabetes
Implantable Insulin Pump
Intraperitoneal Insulin Delivery
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.

Detailed description: Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.

Eligibility criteria: * Type 1 diabetes mellitus (American Diabetes Association definition)
* HbA1c greater than or equal to 7.5%
* Intensive insulin treatment for at least 3 months
* Physical and intellectual ability to operate MIP system
* Subject has been under the routine care of the investigator for at least two months prior to enrollment
* Subject has a reliable support person (defined as a person who has daily contact with the subject and knows whom to contact in the event of an emergency).
* Capability and willingness to perform self-monitoring of blood glucose at least four times daily for 9 months of the study and 7 times daily for 3 months of the study
* Physical and intellectual ability to operate the MIP system and to comply with the data reporting requirements of the study.
* Subject is willing to sign the informed consent form (approved by local Institutional Review Board and Medtronic MiniMed)

Exclusion Criteria:

* The subject's insulin usage exceeds 66 units per day.
* Severe complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months
* Reside at or plan to travel to elevations above 8000 feet during the study period (commercial airline travel is acceptable)
* Subject who is pregnant, of childbearing potential or lactating and is neither surgically sterile, using contraceptives (devices, oral or implanted) nor other physician approved contraceptive
* The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data
* The subject has previously enrolled in or participated in an investigational drug or device study within the preceding 4 weeks
* The subject has any condition that precludes him/her from completing the study requirements
* Has plans for activities which require them to go 25 feet below sea level

Primary outcomes:
measure: Change in HbA1c and Compared Between Groups
timeFrame: Baseline and 12 months
measure: Incidence of Severe Hypoglycemia Events
timeFrame: 12 months
Secondary outcomes:
measure: Average Daily Blood Glucose
timeFrame: average from baseline to 12 months
measure: Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: average from baseline to 12 months
measure: Low Blood Glucose Index (LBGI);
timeFrame: average from baseline to 12 months
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Medical Research Institute
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: North Kansas City
country: United States
facility: Hellman & Rosen Endocrine Associates
state: Missouri
city: Wooser
country: United States
facility: Cleveland Clinic
state: Ohio
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic
state: Texas
Study officials:
affiliation: Medtronic
name: Scott W Lee, MD
role: STUDY_DIRECTOR
References: