Effect Insulin Pump Therapy to Patients With Diabetic Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-20

Study Completion Date

2014-05-16

Brief Summary

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The recent study suggested that oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.

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Detailed Description

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Worldwidely, about 30% of Type 1 Diabetes Mellitus (T1DM) and 20%-50% of T2DM patients suffered diabetic nephropathy (DN). Oxidative stress resulting from increased production of reactive oxygen species (ROS) plays a crucial role in the development of diabetic complications. Insulin pump therapy is better than subcutaneous injection in terms of the drug safety and effectiveness. The researches aim to monitor the level of oxidative stress of patient in different stage of diabetic nephropathy before and after insulin pump therapy.

Conditions

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Insulin Pump Therapy in Treating Diabetic Nephropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Normal group (NC) and Type 2 diabetic (DM) group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin pump therapy

The total requisite amount=0.44×weight (Kg); The preprandial and basal amount respectively took up 50% of integral dose.15 minutes before meal the preprandial insulin was equally given by 3 times. The basal insulin was pumped at 00:00-3:00，3:00-8:00，8:00-14:00，14:00-20:00，20:00-24:00.

Group Type EXPERIMENTAL

Insulin pump

Intervention Type DEVICE

Blood glucose management device

Normal control

The subjects were asked to maintain normal diet and lifestyle until the end of the observation period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Insulin pump

Blood glucose management device

Intervention Type DEVICE

Other Intervention Names

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Diabetes insulin pump

Eligibility Criteria

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Inclusion Criteria

Diabetic patients with fasting plasma glucose (FPG) ≥10mmol/l and/or 2 hours' plasma glucose (2hPG) ≥15mmol/l.

Exclusion Criteria

Diabetic patients who

1. using antioxidant drugs within one month;
2. accompanied with acute and chronic severe complications, fever, malignant tumor, nephritis, congestive heart failure.
3. accompanied with diabetic ketosis, ketoacidosis, severe hypoglycemia, hyperosmolar hyperglycemic state;
4. with other endocrine diseases, autoimmune diseases, or connective tissue diseases;
5. having history of infection within 1 month;
6. having drug or alcohol dependence;
7. severe hypoxia and stress state (e.g., cardiovascular events, trauma, surgery, and consumptive disease, etc.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes