Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Normal bolus
* Drug: Coordinated bolus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal then Coordinated<br>normal bolus during 2 weeks then coordinated bolus during 2 weeks | Drug: Normal bolus<br>* 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<br>Drug: Coordinated bolus<br>* 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.<br>|
| Experimental: Coordinated then Normal<br>coordinated bolus during 2 weeks then normal bolus during 2 weeks | Drug: Normal bolus<br>* 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<br>Drug: Coordinated bolus<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial glycaemia | measured by Self Monitoring of Blood Glucose | 2 hours after eating during 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | Throughout the study (4 weeks) | 
| severe hypoglycaemia frequency |  | Throughout the study (4 weeks) | 
| insulin doses |  | basal rate and boluses | 
| mean glycaemia | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks | 
| standard deviation of glycaemia | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks | 
| frequency of glycaemia < or = 60mg/dl | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks | 
| frequency of glycaemia between 61-140mg/dl | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks | 
| frequency of glycaemia >140mg/dl | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks | 
| mean glycemia | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks | 
| standard deviation | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks | 
| time spent within glucose range < or = 60mg/dl | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks | 
| time spent within glucose range between 61-140mg/dl | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks | 
| time spent within glucose range mg/dl | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks | 
| fructosamine |  | day 1 | 
| fructosamine |  | day 1 + 2 weeks | 
| fructosamine |  | day 1 + 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes