Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients (GlyCEDIA)

Centre Europeen d'Etude du Diabete

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus

Treatments

Drug: Basal-bolus detemir-aspart insulin regimen

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01828970

09/43

Details and patient eligibility

About

The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes

Full description

We conducted a pilot prospective multicenter study in five French centers (Strasbourg University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes) designed to evaluate the feasibility and effects of a 3 month treatment regimen with rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir, respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.

All patients who were admitted to the nephrology departments and matched the inclusion criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment. It was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions. The CGM was continued during the next dialysis session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54 hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of treatment. The probe for the system was subcutaneously inserted at the beginning of the first dialysis session to analyze interstitial glucose, and it was removed at the end of the second dialysis session. Due to the time required for CGM calibration, plasma glucose levels were only partially recorded during the first dialysis session.

Enrollment

38 patients

Sex

All

Ages

18 to 83 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age between 18 and 83 years
diagnosis of type 1 or type 2 diabetes
treatment with insulin injections or oral hypoglycemic agents
HbA1c ≥ 7% (i.e., 53 mmol/mol)
on hemodialysis for more than three months

Exclusion criteria

unstable anemia or blood transfusions within the two months prior to the beginning of the study
a life expectancy of less than 1 year
chronic inflammatory disease
evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
noncompliant patients