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Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

NCT02229097 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-02-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Normal 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

DRUG

Coordinated 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 & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Vincent Melki, Doctor · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229097 on ClinicalTrials.gov