Type 1 Diabetes
Conditions
Keywords
type 1 diabetes
Brief summary
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.
Interventions
DRUGNormal bolus
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
DRUGCoordinated bolus
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.
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postprandial glycaemia | 2 hours after eating during 4 weeks | measured by Self Monitoring of Blood Glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severe hypoglycaemia frequency | Throughout the study (4 weeks) | — |
| insulin doses | basal rate and boluses | — |
| mean glycaemia | before eating and 2 hours after eating during 4 weeks | data from Self Monitoring of Blood Glucose |
| standard deviation of glycaemia | before eating and 2 hours after eating during 4 weeks | data from Self Monitoring of Blood Glucose |
| frequency of glycaemia < or = 60mg/dl | before eating and 2 hours after eating during 4 weeks | data from Self Monitoring of Blood Glucose |
| frequency of glycaemia between 61-140mg/dl | before eating and 2 hours after eating during 4 weeks | data from Self Monitoring of Blood Glucose |
| adverse events | Throughout the study (4 weeks) | — |
| mean glycemia | Throughout the day during 4 weeks | data from Continue Glycemia Monitoring |
| standard deviation | Throughout the day during 4 weeks | data from Continue Glycemia Monitoring |
| time spent within glucose range < or = 60mg/dl | Throughout the day during 4 weeks | data from Continue Glycemia Monitoring |
| time spent within glucose range between 61-140mg/dl | Throughout the day during 4 weeks | data from Continue Glycemia Monitoring |
| time spent within glucose range mg/dl | Throughout the day during 4 weeks | data from Continue Glycemia Monitoring |
| fructosamine | day 1 | — |
| frequency of glycaemia >140mg/dl | before eating and 2 hours after eating during 4 weeks | data from Self Monitoring of Blood Glucose |
Countries
France
Outcome results
None listed