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Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system

Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system - Investigation optimal dosing of insulin detemir after switching from other basal insulin by using CGM system

Status
Unknown
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000002267
Enrollment
20
Registered
2009-08-01
Start date
2009-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

None listed

Sponsors

Tokyo Women's Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Hospitalized patient in Tokyo Women's Medical University with type 1 or insulin-depleted type 2 mellitus (fasting plasma CPR <1microg) 2.Patient who is considered to change insulin therapy because target HbA1c has not been reached and blood glucose level fluctuates wildly in current insulin therapy. 3.A consent form for participating in this study is submitted 4.Males and females of age >= 20 years 5.Patient treated by basal-bolus insulin regimen using rapid-acting insulin analogue (insulin aspart or insulin lispro) and NPH or insulin glargine over 3 months 6.HbA1c >= 8.0 %, <=11.0% 7.BMI <= 26 kg/m2 8.Patient who dose not use sulfonil-urea and pioglitazone

Exclusion criteria

Exclusion criteria: 1.Pregnant, or intention of becoming pregnant. 2.Patients who are judged by investigators as inappropriate subject to participant this trail.

Design outcomes

Primary

MeasureTime frame
Variability during 24 hours (Sum of difference from average blood glucose level)

Secondary

MeasureTime frame
-Difference between maximum blood glucose level and minimum blood glucose level (average of 3 days) -Number of hypoglycemia (BG<=50mg/dL) -Number of hyperglycemia (BG>=300mg/dL) -Change of HbA1c -Change of 1.5AG -Over all adverse events -Circumference of waist and hip -Change of height, weight, BMI -Change of insulin dose (total dose, basal dose, bolus dose)

Countries

Japan

Contacts

Public ContactJunnosuke Miura

Tokyo Women's Medical University Diabetes Center

03-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026