Effect of CSII and CGM on Progression of Late Diabetic Complications

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454700
• Other study ID #: H-3-2011-122
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2011
• Last updated: January 13, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
Randomization to 12 months with CSII plus CGM

Other:
• Multiple daily insulin injections (MDI)
Randomization12 months therapy with MDI

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Steen Andersen	Medtronic

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	difference in change of HbA1c from baseline to 12 months		12 months	No
Secondary	difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles		12 months	No
Secondary	difference in change of 24-hour blood pressure		12 months	No
Secondary	difference in change of glomerular filtration rate (GFR)		12 months	No
Secondary	difference in the occurence or progression of retinopathy		12 months	No
Secondary	difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP		12 months	No
Secondary	difference in endothelial cell dysfunction		12 months	No
Secondary	difference in carotid intima media thickness (CIMT)		12 months	No