Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

University Hospital, Toulouse17 enrolled

Overview

A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias. The aim of the investigators study is to assess if these results are confirmed in a clinical trial. The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Normal bolusDRUG

During the "normal bolus" period, the bolus will be adjusted to the carbohydrate content of each meal and injected immediately. The basal rate will remain at a normal level during the 3 hours postprandial period

Coordinated bolusDRUG

The basal rate will be reduced at a rate of 0.1 U/h during the 3 h postprandial period. The insulin subtracted of the basal rate will be added to the normal bolus calculated for the meal and injected immediately.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes mellitus * with confirmed Negative C-peptide or diabetes duration\>5 years * Treated by external insulin pump and rapid insulin analog for more than 3 months * using a Medtronic Paradigm Real-Time or Veo™ model * Educated to and practicing functional insulin treatment and carbohydrate counting for more than 3 months * Able to use the "basal temp" and "glycaemia reminder" functions of their pump * Basal infusion rate ≥ 0,5 Unit/h * Self-monitoring of blood glucose frequency \> 4/days * Aware of hypoglycaemia Exclusion Criteria: * known impaired renal function (creatinin clearance \<60ml/min) * Gastroparesis * Serious or instable disease likely to induce a glycaemic control deterioration - treatment with corticosteroids

Locations (3)

University Hospital Toulouse Rangueil

Toulouse, Haute Garonne, France

Saint-André Hospital

Bordeaux, France

Lapeyronie Hospital

Montpellier, France

Outcomes

Primary Outcomes

postprandial glycaemia

measured by Self Monitoring of Blood Glucose

Time frame: 2 hours after eating during 4 weeks

Secondary Outcomes

adverse events

Time frame: Throughout the study (4 weeks)

severe hypoglycaemia frequency

Time frame: Throughout the study (4 weeks)

insulin doses

Time frame: basal rate and boluses

mean glycaemia

data from Self Monitoring of Blood Glucose