Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Hemodialysis, Continuous glucose monitoring, Insulin analogues
Brief summary
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
Detailed 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.
Interventions
DRUGBasal-bolus detemir-aspart insulin regimen
After the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily. The analogues were titrated for optimal glycemic control. After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.
Sponsors
Novo Nordisk A/S
Abbott
Centre Europeen d'Etude du Diabete
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 83 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean plasma glucose level measured 3 times just before the first hemodialysis session | Baseline and at 3 months of treatment | Determination by the glucose dehydrogenase method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline and at 3 months of treatment | Measured by high-performance liquid chromatography |
| Body weight | Baseline and at 1 month and 3 months of treatment | — |
| Insulin requirements | Baseline and at 1 month and 3 months of treatment | IU per day |
| Symptomatic hypoglycemia | Baseline and at 1 month and 3 months of treatment | Number of glycemia \< 60 mg/dl per patient and per month |
| Continuous glucose monitoring parameters | Baseline and at 1 month and 3 months of treatment | Including: mean continuous glucose monitoring glucose values, within-subjects standard deviation (wSD) and coefficient of variation (wCV = wSD/mean), mean amplitude of glycemic excursion (MAGE), frequency of glucose values under 60 mg/dl, and frequency of glucose values higher than 180 mg/dl |
| Deaths and major cardiovascular events | Baseline and at 3 months of treatment | All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease |
Countries
France
Outcome results
None listed