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Completed

NCT Number: NCT01828970

Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–83 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional Hospital of Colmar, Colmar, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basal-bolus detemir-aspart insulin regimen

Drug

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.

Other names: Levemir, Novorapid

Primary outcomes

  1. Mean plasma glucose level measured 3 times just before the first hemodialysis session

    Time frame: Baseline and at 3 months of treatment

    Determination by the glucose dehydrogenase method

Secondary outcomes

  1. HbA1c

    Time frame: Baseline and at 3 months of treatment

    Measured by high-performance liquid chromatography

  2. Body weight

    Time frame: Baseline and at 1 month and 3 months of treatment

  3. Insulin requirements

    Time frame: Baseline and at 1 month and 3 months of treatment

    IU per day

  4. Symptomatic hypoglycemia

    Time frame: Baseline and at 1 month and 3 months of treatment

    Number of glycemia < 60 mg/dl per patient and per month

  5. Continuous glucose monitoring parameters

    Time frame: 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

  6. Deaths and major cardiovascular events

    Time frame: Baseline and at 3 months of treatment

    All-cause mortality Major cardiovascular events including: myocardial infarction, stroke, and peripheral vascular disease

Sponsors and collaborators

Lead sponsor

Centre Europeen d'Etude du Diabete

Other

Collaborators

  • Abbott
  • Novo Nordisk A/S

Registry information

Official study 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

Acronym: GlyCEDIA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2013
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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