Effect of CSII and CGM on Progression of Late Diabetic Complications

Study Overview
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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

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.

Official Title
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The Effect of Sensor-Augmented Continuous Subcutaneous Insulin Infusion Compared to Multiple Daily Insulin Injections in Prevention of Increasing Urinary Albumin Excretion Rate in Type 1 Diabetes Mellitus

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
* Other: Multiple daily insulin injections (MDI)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSII plus CGM<br>Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring. | Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)<br>* Randomization to 12 months with CSII plus CGM<br>* Other names: Sensor augmented insulin pump therapy;|
| Active Comparator: Multiple daily insulin injections<br>randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen). | Other: Multiple daily insulin injections (MDI)<br>* Randomization12 months therapy with MDI<br>* Other names: Insulin analogues;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in change of HbA1c from baseline to 12 months |  | 12 months | 
| difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles |  | 12 months | 
| difference in change of 24-hour blood pressure |  | 12 months | 
| difference in change of glomerular filtration rate (GFR) |  | 12 months | 
| difference in the occurence or progression of retinopathy |  | 12 months | 
| difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP |  | 12 months | 
| difference in endothelial cell dysfunction |  | 12 months | 
| difference in carotid intima media thickness (CIMT) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM, Albuminuria, Type 1 diabetes mellitus, Late diabetes complications, CSII, Glycaemic control