Effect of CSII and CGM on Progression of Late Diabetic Complications
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Other: Multiple daily insulin injections (MDI)Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
- Registration Number
- NCT01454700
- Lead Sponsor
- Steen Andersen
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiple daily insulin injections Multiple daily insulin injections (MDI) randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen). CSII plus CGM Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.
- Primary Outcome Measures
Name Time Method difference in change in urine albumine excretion from baseline to end of study (12 months) 12 months Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.
- Secondary Outcome Measures
Name Time Method difference in endothelial cell dysfunction 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 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 cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP 12 months difference in carotid intima media thickness (CIMT) 12 months
Trial Locations
- Locations (1)
Steno Diabetes Center
🇩🇰Gentofte, Copenhagen, Denmark