Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

Diabetes Mellitus Clinical Trial

— GlyCEDIA  

Official title:

Glycemic Control Assessed by Continuous Glucose Monitoring in Hemodialyzed Patients With Diabetes Mellitus Treated Via the Basal-Bolus Detemir-Aspart Insulin Regimen: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828970
• Other study ID #: 09/43
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2013
• Last updated: April 9, 2013
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Centre Europeen d'Etude du Diabete
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 83 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Basal-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.

Locations

Country	Name	City	State
France	Regional Hospital of Colmar	Colmar
France	Regional Hospital of Mulhouse	Mulhouse
France	Sainte Anne Hospital	Strasbourg
France	University Hospital of Strasbourg	Strasbourg
France	Regional Hospital of Valenciennes	Valenciennes

Sponsors (3)

Lead Sponsor	Collaborator
Centre Europeen d'Etude du Diabete	Abbott, Novo Nordisk A/S

Country where clinical trial is conducted

France, 

References & Publications (30)

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Kazempour-Ardebili S, Lecamwasam VL, Dassanyake T, Frankel AH, Tam FW, Dornhorst A, Frost G, Turner JJ. Assessing glycemic control in maintenance hemodialysis patients with type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1137-42. doi: 10.2337/dc08-1688. Epub 2009 Feb 5. — View Citation

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Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Lüddeke HJ. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007 May;9(3):418-27. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean plasma glucose level measured 3 times just before the first hemodialysis session	Determination by the glucose dehydrogenase method	Baseline and at 3 months of treatment	No
Secondary	HbA1c	Measured by high-performance liquid chromatography	Baseline and at 3 months of treatment	No
Secondary	Body weight		Baseline and at 1 month and 3 months of treatment	No
Secondary	Insulin requirements	IU per day	Baseline and at 1 month and 3 months of treatment	No
Secondary	Symptomatic hypoglycemia	Number of glycemia < 60 mg/dl per patient and per month	Baseline and at 1 month and 3 months of treatment	No
Secondary	Continuous glucose monitoring parameters	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	Baseline and at 1 month and 3 months of treatment	No
Secondary	Deaths and major cardiovascular events	All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease	Baseline and at 3 months of treatment	Yes