Type 1 Diabetes MellitusPhase 4NCT01454700
Effect of CSII and CGM on Progression of Late Diabetic Complications
A Phase 4 study testing Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) and Multiple daily insulin injections (MDI) in people with Type 1 Diabetes Mellitus, run by Steen Andersen at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) and Multiple daily insulin injections (MDI)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM), Multiple daily insulin injections (MDI)
- Keywords
- Type 1 diabetes mellitus, Albuminuria, Late diabetes complications, CSII, CGM, Glycaemic control
- Medical subject headings
- Diabetes Mellitus, Type 1, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)Device
Also called CSII, CGM, Medtronic MiniMed Paradigm REAL-Time System, Medtronic MiniMed Paradigm Veo
Randomization to 12 months with CSII plus CGM
Multiple daily insulin injections (MDI)Other
Also called Human insulin, Insulin analogues
Randomization12 months therapy with MDI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) |
| Multiple daily insulin injections | Active comparator | randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen). Receives: Other: Multiple daily insulin injections (MDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
difference in change of HbA1c from baseline to 12 months
Measured: 12 months
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles
Measured: 12 months
difference in change of 24-hour blood pressure
Measured: 12 months
difference in change of glomerular filtration rate (GFR)
Measured: 12 months
difference in the occurence or progression of retinopathy
Measured: 12 months
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP
Measured: 12 months
difference in endothelial cell dysfunction
Measured: 12 months
difference in carotid intima media thickness (CIMT)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steen Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Steen Andersen, Steno Diabetes Center Copenhagen
- Investigators
- Steen Andersen, MD, DMSc, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454700
- Sponsor's protocol ID
- H-3-2011-122
- Status last verified
- Jan 2015
- First submitted
- 17 Oct 2011
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32887707Rosenlund 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.
PubMed 26390102
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01454700
- Acronym / sponsor ID
- H-3-2011-122
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Albuminuria, Late diabetes complications, CSII, CGM, Glycaemic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Steen AndersenUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSII plus CGM | Experimental | Device: 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. |
| Multiple daily insulin injections | Active comparator | Other: Multiple daily insulin injections (MDI)randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)Also: CSII, CGM, Medtronic MiniMed Paradigm REAL-Time System, Medtronic MiniMed Paradigm VeoRandomization to 12 months with CSII plus CGM | Device | CSII plus CGM |
| Multiple daily insulin injections (MDI)Also: Human insulin, Insulin analoguesRandomization12 months therapy with MDI | Other | Multiple daily insulin injections |
Primary outcome
difference in change in urine albumine excretion from baseline to end of study (12 months)
Time frame: 12 months
Urine albumin excretion is evaluated at screening, at entry, after 1,3,6,9, and 12 months.
8 secondary outcomes
difference in change of HbA1c from baseline to 12 months
Time frame: 12 months
difference in change in self-monitored blood glucose (SMBG) measurement 4-point glucose profiles
Time frame: 12 months
difference in change of 24-hour blood pressure
Time frame: 12 months
difference in change of glomerular filtration rate (GFR)
Time frame: 12 months
difference in the occurence or progression of retinopathy
Time frame: 12 months
difference in change of cardiovascular biomarkers of inflammation, lipid metabolism and NT-proBNP
Time frame: 12 months
difference in endothelial cell dysfunction
Time frame: 12 months
difference in carotid intima media thickness (CIMT)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Derived from this study: PubMed 32887707Ranjan 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.
- Derived from this study: PubMed 26390102Rosenlund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen Andersen, MD, DMSc principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) and Multiple daily insulin injections (MDI) in people with Type 1 Diabetes Mellitus, run by Steen Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in change in urine albumine excretion from baseline to end of study (12 months) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454700, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.