Effect of CSII and CGM on Progression of Late Diabetic Complications

Steen Andersen60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

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

Randomization to 12 months with CSII plus CGM

Multiple daily insulin injections (MDI)OTHER

Randomization12 months therapy with MDI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Steno Diabetes Center

Gentofte Municipality, Copenhagen, Denmark

Outcomes

Primary Outcomes

difference in change in urine albumine excretion from baseline to end of study (12 months)

Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.

Time frame: 12 months

Secondary Outcomes

difference in change of HbA1c from baseline to 12 months

Time frame: 12 months

difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles

Time frame: 12 months

difference in change of 24-hour blood pressure

Time frame: 12 months

difference in change of glomerular filtration rate (GFR)

Time frame: 12 months

difference in the occurence or progression of retinopathy

Time frame: 12 months

difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP

Time frame: 12 months

difference in endothelial cell dysfunction

Time frame: 12 months

difference in carotid intima media thickness (CIMT)

Time frame: 12 months

Data from ClinicalTrials.gov

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