Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes mellitus type 2, glycemic control, glycated albumin, continuous glucose monitoring, fructosamine, glycated hemoglobin, insulin, premixed human insulin, premixed insulin analog
Brief summary
Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices
Detailed description
A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.
Interventions
DRUGPremixed Human Isophane Insulin Suspension + Human Insulin Injection
premixed human insulin
DRUGPremixed Insulin
Premixed Insulin Analog Biphasic Aspart 30
Sponsors
University Hospital Tuebingen
Aristotle University Of Thessaloniki
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cross-over
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* regular attendees of Outpatient Clinic of the Diabetes Centre of the 1st Department of Internal Medicine of University Hospital in Thessaloniki Greece * The patients were on Premixed Human Insulin 30/70 twice daily with or without metformin * baseline HbA1c\<7%
Exclusion criteria
* the presence of type 1 Diabetes Mellitus * stage 4 Chronic Kidney Disease * use of antidiabetic medications other than insulin and metformin * major cardiovascular event during the last six months * acute illness and hospitalization during the last two weeks * pregnancy * absence of good metabolic control assessed with self-monitoring of blood glucose during the week before entering the study (\>20% of the measurements \<80mg/dl or \>130mg/dl) * inability of the patients to understand the study procedures and sign the consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in average blood glucose | 7 days | average blood glucose (mg/dl) from continuous glucose monitoring |
| Glycated Albumin | 7 days | levels of glycated albumin (%) in serum |
| Fructosamine | 7 days | levels of fructosamine (μmol/L) in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time above 180 | 7 days | change in time above 180 (% and minutes) from continuous glucose monitoring |
| Daily Insulin requirements | 7 days | change in total daily dose of insulin (u) |
| time below 70 | 7 days | change in time below 70 (% and minutes) from continuous glucose monitoring |
| nocturnal average blood glucose | 7 days | change in nocturnal average blood glucose |
| Time in range | 7 days | change in time in range (% and minutes) from continuous glucose monitoring |
Outcome results
None listed