Effects of Shifting From Twice Daily Insulin Glargine or Detemir to Once Daily Insulin Degludec in Type 1 Diabetes
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Rationale. Degludec is a longer-acting insulin analog compared to glargine and detemir. In a
fraction of type 1 diabetic patients, insulin glargine and insulin detemir may not achieve
24h coverage, reflected by raising pre-dinner glucose levels when they are administered at
bedtime. As up-titration of bedtime long acting insulin increases risk of nocturnal
hypoglycaemia, this clinical problem can be addressed by an additional injection of in the
morning. These type 1 diabetic patients may benefit from shifting from twice daily insulin
glargine/detemir to once daily insulin degludec, which shows an extended activity over 24h,
up to 48h.
Objective. To evaluate the effects of shifting from twice daily insulin glargine or detemir
to once daily insulin degludec on HbA1c and glucose profiles in type 1 diabetic patients
during a period of 3 months.
Study design. Observational analytic prospective study. Protocol. Type 1 diabetic patients on
twice daily insulin glargine or detemir (because of pre-dinner hyperglycemia due to supposed
glargine/detemir coverage <24h) will be identified and enrolled. During a run-in period of 1
week, the investigators will collect data on HbA1c values as IFCC/DCCT-aligned and on glucose
profiles using glucose meters. Patients will undergo a 7-14 day continuous glucose monitoring
before and eventually during (additional 7-14 days) the shift from twice to once daily basal
insulin. Patients will be re-assessed 12 weeks after initiation of insulin degludec with
determination of HbA1c and 7-14 day continuous glucose monitoring.