Clinical trial NCT01454700: Effect of CSII and CGM on Progression of Late Diabetic Complications
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Albuminuria
Late diabetes complications
CSII
CGM
Glycaemic control
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: difference in change in urine albumine excretion from baseline to end of study (12 months)
timeFrame: 12 months
Secondary outcomes:
measure: difference in change of HbA1c from baseline to 12 months
timeFrame: 12 months
measure: difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles
timeFrame: 12 months
measure: difference in change of 24-hour blood pressure
timeFrame: 12 months
measure: difference in change of glomerular filtration rate (GFR)
timeFrame: 12 months
measure: difference in the occurence or progression of retinopathy
timeFrame: 12 months
measure: difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP
timeFrame: 12 months
measure: difference in endothelial cell dysfunction
timeFrame: 12 months
measure: difference in carotid intima media thickness (CIMT)
timeFrame: 12 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
state: Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Steen Andersen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranjan AG, Rosenlund SV, Hansen TW, Rossing P, Andersen S, Norgaard K. Improved Time in Range Over 1 Year Is Associated With Reduced Albuminuria in Individuals With Sensor-Augmented Insulin Pump-Treated Type 1 Diabetes. Diabetes Care. 2020 Nov;43(11):2882-2885. doi: 10.2337/dc20-0909. Epub 2020 Sep 4.
citation: Rosenlund S, Hansen TW, Rossing P, Andersen S. Effect of Sensor-Augmented Pump Treatment Versus Multiple Daily Injections on Albuminuria: A 1-Year Randomized Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4181-8. doi: 10.1210/jc.2015-2839. Epub 2015 Sep 21.