Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

Medtronic MiniMed, Inc.107 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Type 1 Diabetes

Interventions

Medtronic MiniMed Implantable Pump Human Recombinant InsulinDRUG

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Medtronic MiniMed Implantable Pump SystemDEVICE

The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.

Aventis HOE21PH U400DRUG

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

* 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

Locations (5)

Sansum Medical Research Institute

Santa Barbara, California, United States

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Hellman & Rosen Endocrine Associates

North Kansas City, Missouri, United States

Cleveland Clinic

Wooser, Ohio, United States

Outcomes

Primary Outcomes

Change in HbA1c and Compared Between Groups

To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts.

Time frame: Baseline and 12 months

Incidence of Severe Hypoglycemia Events

The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months.

Time frame: 12 months

Secondary Outcomes

Average Daily Blood Glucose

For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.

Time frame: average from baseline to 12 months

Mean Amplitude of Glycemic Excursions (MAGE)

MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.

Data from ClinicalTrials.gov

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