Effect of CSII and CGM on Progression of Late Diabetic Complications
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
Multiple daily insulin injections (MDI)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes mellitus, Albuminuria, Late diabetes complications, CSII, CGM, Glycaemic control
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.
Sites / Locations
- Steno Diabetes Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CSII plus CGM
Multiple daily insulin injections
Arm Description
Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.
randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
difference in change of HbA1c from baseline to 12 months
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles
difference in change of 24-hour blood pressure
difference in change of glomerular filtration rate (GFR)
difference in the occurence or progression of retinopathy
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP
difference in endothelial cell dysfunction
difference in carotid intima media thickness (CIMT)
Full Information
NCT ID
NCT01454700
First Posted
October 17, 2011
Last Updated
January 13, 2015
Sponsor
Steen Andersen
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT01454700
Brief Title
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
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steen Andersen
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 diabetes mellitus, Albuminuria, Late diabetes complications, CSII, CGM, Glycaemic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSII plus CGM
Arm Type
Experimental
Arm Description
Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.
Arm Title
Multiple daily insulin injections
Arm Type
Active Comparator
Arm Description
randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen).
Intervention Type
Device
Intervention Name(s)
Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)
Other Intervention Name(s)
CSII, CGM, Medtronic MiniMed Paradigm REAL-Time System, Medtronic MiniMed Paradigm Veo, Sensor augmented insulin pump therapy
Intervention Description
Randomization to 12 months with CSII plus CGM
Intervention Type
Other
Intervention Name(s)
Multiple daily insulin injections (MDI)
Other Intervention Name(s)
Human insulin, Insulin analogues
Intervention Description
Randomization12 months therapy with MDI
Primary Outcome Measure Information:
Title
difference in change in urine albumine excretion from baseline to end of study (12 months)
Description
Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
difference in change of HbA1c from baseline to 12 months
Time Frame
12 months
Title
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles
Time Frame
12 months
Title
difference in change of 24-hour blood pressure
Time Frame
12 months
Title
difference in change of glomerular filtration rate (GFR)
Time Frame
12 months
Title
difference in the occurence or progression of retinopathy
Time Frame
12 months
Title
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP
Time Frame
12 months
Title
difference in endothelial cell dysfunction
Time Frame
12 months
Title
difference in carotid intima media thickness (CIMT)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steen Andersen, MD, DMSc
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center
City
Gentofte
State/Province
Copenhagen
ZIP/Postal Code
2820
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
32887707
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.
Results Reference
derived
PubMed Identifier
26390102
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.
Results Reference
derived
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Effect of CSII and CGM on Progression of Late Diabetic Complications
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