Effect of CSII and CGM on Progression of Late Diabetic Complications

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of the study is to investigate whether the combination of insulin pump therapy and continued glucose monitoring (CGM) is superior to multiple daily insulin injections to prevent progression of albuminuria in patients with type 1 diabetes

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Detailed Description

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80 type 1 diabetic patients with kidney function (GFR \> 45 ml/min), but with urine albumin excretion of at least 30 mg/day and HbA1c 7.5-13.0% are randomised to either multiple daily insulin injections (control group) or insulin pump therapy plus continued glucose monitoring (CGM) (intervention group). Patients must be in stable RAAS blockade before entering the study.

Before the study is initiated all patients receive education in intensive diabetes treatment and self-care including carbohydrate counting.

Patients return to the clinic after 1,3,6,9, and 12 months for measurement of urine albumine excretion, clinical examination including blood pressure, CGM sensor readings, four-point self monitored blood glucose (SMBG) profiles, blood samples and fulfillment of questionnaire to assess quality of life. At entry and after 12 months, eye fundus foto, 24-hour blood pressure, GFR, and carotis intima media thickness (CIMT)are also evaluated.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CSII plus CGM

Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.

Group Type EXPERIMENTAL

Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)

Intervention Type DEVICE

Randomization to 12 months with CSII plus CGM

Multiple daily insulin injections

randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen).

Group Type ACTIVE_COMPARATOR

Multiple daily insulin injections (MDI)

Intervention Type OTHER

Randomization12 months therapy with MDI

Interventions

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Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)

Randomization to 12 months with CSII plus CGM

Intervention Type DEVICE

Multiple daily insulin injections (MDI)

Randomization12 months therapy with MDI

Intervention Type OTHER

Other Intervention Names

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CSII CGM Medtronic MiniMed Paradigm REAL-Time System Medtronic MiniMed Paradigm Veo Sensor augmented insulin pump therapy Human insulin Insulin analogues

Eligibility Criteria

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Inclusion Criteria

* 18-75 years of age,
* Type 1 diabetes according to WHO criteria,
* Urin albumine \> 30 mg/g (albumine/creatinine ratio),
* HbA1c \> 7.5 \< 13.0%,
* No change in RAAS blocking treatment at least 4 weeks prior to screening.

Exclusion Criteria

* Kidney disease other that diabetic nephropathy,
* Recurrence of severe hypoglycaemia or hypoglycaemia unawareness as judged by the investigator,
* Use of insulin pump within 12 months,
* Acute myocardial infarction within 3 months,
* Severe arteriosclerosis as judged by the investigator,
* Heart failure (NYHA class 3 or 4),
* Abuse of alcohol or drugs,
* Any cancer diagnosis unless in remission at least 5 years prior to screening,
* Participation in other intervention studies,
* Pregnant or lactating women,
* Any other disease, condition or type of treatment which - as judged by the investigator - render the patient ineligible to participate in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No