Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients
- Conditions
- Type 1 Diabetes
- Interventions
- Drug: Normal bolusDrug: Coordinated bolus
- Registration Number
- NCT02229097
- Lead Sponsor
- University Hospital, Toulouse
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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
- known impaired renal function (creatinin clearance <60ml/min)
- Gastroparesis
- Serious or instable disease likely to induce a glycaemic control deterioration - treatment with corticosteroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Normal then Coordinated Normal bolus normal bolus during 2 weeks then coordinated bolus during 2 weeks Normal then Coordinated Coordinated bolus normal bolus during 2 weeks then coordinated bolus during 2 weeks Coordinated then Normal Normal bolus coordinated bolus during 2 weeks then normal bolus during 2 weeks Coordinated then Normal Coordinated bolus coordinated bolus during 2 weeks then normal bolus during 2 weeks
- Primary Outcome Measures
Name Time Method postprandial glycaemia 2 hours after eating during 4 weeks measured by Self Monitoring of Blood Glucose
- Secondary Outcome Measures
Name Time Method mean glycaemia before eating and 2 hours after eating during 4 weeks data from Self Monitoring of Blood Glucose
adverse events Throughout the study (4 weeks) severe hypoglycaemia frequency Throughout the study (4 weeks) insulin doses basal rate and boluses 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
standard deviation of glycaemia before eating and 2 hours after eating during 4 weeks data from Self Monitoring of Blood Glucose
frequency of glycaemia >140mg/dl before eating and 2 hours after eating during 4 weeks data from Self Monitoring of Blood Glucose
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 + 4 weeks
Trial Locations
- Locations (3)
Saint-André Hospital
🇫🇷Bordeaux, France
Lapeyronie Hospital
🇫🇷Montpellier, France
University Hospital Toulouse Rangueil
🇫🇷Toulouse, Haute Garonne, France