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Comparative study between effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation -Investigasion using flash glucose monitoring system-

Comparative study between effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation -Investigasion using flash glucose monitoring system- - Effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026829
Enrollment
50
Registered
2017-06-01
Start date
2018-03-31
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 mellitus

Interventions

1 Install Freestyle Libre Pro (Abbott) for 2 weeks (one sensor). 2 From day 6, switch the basal insulin from insulin degludec to insulin glargine U300, while keeping the same number of units and inje

Sponsors

Fukuiken Saisekai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 Outpatient visit or hospitalized patients with diabetes 2 Continue to use insulin deglug or insulin glargine U 300 for three months or more, during which the contents of other diabetes remedies are unchanged 3 HbA1c (NGSP value) is 6% or more but less than 9%

Exclusion criteria

Exclusion criteria: 1 Patients with a clear history of ischemic heart disease (angina, myocardial infarction), ischemic cerebrovascular disease 2 Patients with HbA1c fluctuating by 2% or more within 3 months 3 Severe ketosis, diabetic coma or prematurity 4 Patients with severe infection, preoperative, severe trauma 5 Cases judged by other physicians to be ineligible

Design outcomes

Primary

MeasureTime frame
For the first 5 days and last 5 days in the midnight to 6AM time zone 1 mean blood sugar level 2 Standard Deviation 3 Mean amplitude of glucose excursion

Secondary

MeasureTime frame
For the first 5 days and last 5 days in the midnight to 6 AM time zone 1 Percentage of time zone with blood glucose level less than 70 mg per dl and its AUC 2 Percentage of time zone with blood sugar level less than 50 mg per dl and its AUC 3 Percentage of time zone with blood glucose level 140 mg per dl and its AUC

Countries

Japan

Contacts

Public ContactKazuo Notsumata

Fukuiken Saisekai Hospital Internal medicine

bando.yukihiro5002@fukui.saiseikai.or.jp0776231111

Outcome results

None listed

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