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OpenTrials
Completed

NCT Number: NCT02229097

Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Toulouse Rangueil, Toulouse, Haute Garonne, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal bolus

Drug

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 bolus

Drug

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.

Primary outcomes

  1. postprandial glycaemia

    Time frame: 2 hours after eating during 4 weeks

    measured by Self Monitoring of Blood Glucose

Secondary outcomes

  1. adverse events

    Time frame: Throughout the study (4 weeks)

  2. severe hypoglycaemia frequency

    Time frame: Throughout the study (4 weeks)

  3. insulin doses

    Time frame: basal rate and boluses

  4. mean glycaemia

    Time frame: before eating and 2 hours after eating during 4 weeks

    data from Self Monitoring of Blood Glucose

  5. standard deviation of glycaemia

    Time frame: before eating and 2 hours after eating during 4 weeks

    data from Self Monitoring of Blood Glucose

  6. frequency of glycaemia < or = 60mg/dl

    Time frame: before eating and 2 hours after eating during 4 weeks

    data from Self Monitoring of Blood Glucose

  7. frequency of glycaemia between 61-140mg/dl

    Time frame: before eating and 2 hours after eating during 4 weeks

    data from Self Monitoring of Blood Glucose

  8. frequency of glycaemia >140mg/dl

    Time frame: before eating and 2 hours after eating during 4 weeks

    data from Self Monitoring of Blood Glucose

  9. mean glycemia

    Time frame: Throughout the day during 4 weeks

    data from Continue Glycemia Monitoring

  10. standard deviation

    Time frame: Throughout the day during 4 weeks

    data from Continue Glycemia Monitoring

  11. time spent within glucose range < or = 60mg/dl

    Time frame: Throughout the day during 4 weeks

    data from Continue Glycemia Monitoring

  12. time spent within glucose range between 61-140mg/dl

    Time frame: Throughout the day during 4 weeks

    data from Continue Glycemia Monitoring

  13. time spent within glucose range mg/dl

    Time frame: Throughout the day during 4 weeks

    data from Continue Glycemia Monitoring

  14. fructosamine

    Time frame: day 1

  15. fructosamine

    Time frame: day 1 + 2 weeks

  16. fructosamine

    Time frame: day 1 + 4 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: COBOL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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