Overview

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:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Padova
Collaborator:
Azienda Ospedaliera di Padova
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
Inclusion Criteria:

- Age 18-65

- Males or females

- type 1 diabetes

- a plan to shift from twice daily glargine or detemir to once daily degludec

- HbA1c >=7.0%

- Informed consent

Exclusion Criteria:

- Age <18 or >65

- HbA1c <7.0%

- Pregnancy or lactation

- Recent (within 3 months) acute diseases or surgery

- Cancer

- Inability to provide informed consent