Effect of CSII and CGM on Progression of Late Diabetic Complications

Steen Andersen

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes Mellitus

Treatments: Other: Multiple daily insulin injections (MDI); Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01454700

H-3-2011-122

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CSII plus CGM

Experimental group

Description:

Patients who has never been treated with insulin pump are randomized to 12 months with insulin pump therapy plus continuous glucose monitoring.

Treatment:

Device: Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)

Multiple daily insulin injections

Active Comparator group

Description:

randomized to 12 months standard/usual insulin regimen (multiple daily injections). (stays on insulin pen).

Treatment:

Other: Multiple daily insulin injections (MDI)