CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Normal bolus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02229097
NCT02229097Phase 4Completed

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

University Hospital, Toulouse·interventional·Posted Aug 29, 2014·Updated Feb 23, 2017

In Brief

A Phase 4 clinical trial evaluating Normal bolus and Coordinated bolus for Type 1 Diabetes. Completed, enrolled 17 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 29, 2014
Enrollment StartOct 1, 2014
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.8 years ago

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.