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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSII plus CGM | Experimental | Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring. |
|
| Multiple daily insulin injections | Active Comparator | randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) | Device | Randomization to 12 months with CSII plus CGM |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steen Andersen, MD, DMSc | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center | Gentofte Municipality | Copenhagen | 2820 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32887707 | Derived | 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. | |
| 26390102 | Derived |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D000092005 | Insulin Secretagogues |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Multiple daily insulin injections (MDI) | Other | Randomization12 months therapy with MDI |
|
|
| 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 |
| 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |