Effect of CSII and CGM on Progression of Late Diabetic Complications

NCT01454700 | Completed Phase 4

• 1 other identifier: H-3-2011-122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus; Albuminuria; Late diabetes complications; CSII; CGM; Glycaemic control

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

• 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

Study Arms (2)

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.

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).

Other: Multiple daily insulin injections (MDI)

Interventions

Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM) DEVICE

Randomization to 12 months with CSII plus CGM

Also known as: CSII, CGM, Medtronic MiniMed Paradigm REAL-Time System, Medtronic MiniMed Paradigm Veo, Sensor augmented insulin pump therapy

CSII plus CGM

Multiple daily insulin injections (MDI) OTHER

Randomization12 months therapy with MDI

Also known as: Human insulin, Insulin analogues

Multiple daily insulin injections

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steen Andersen: lead
• Medtronic: collaborator

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, Copenhagen, 2820, Denmark

Location

Related Publications (2)

• 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.

  PMID: 32887707 DERIVED

• 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.

  PMID: 26390102 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Albuminuria

Interventions

Insulin; Insulin Secretagogues

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Proteinuria; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Hypoglycemic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Steen Andersen, MD, DMSc

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician, DMSc

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 19, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

DK (1)