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Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients (COBOL)

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ClinicalTrials.gov Identifier: NCT02229097
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Normal bolus Drug: Coordinated bolus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study
Actual Study Start Date : October 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Normal then Coordinated
normal bolus during 2 weeks then coordinated bolus during 2 weeks
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.

Experimental: Coordinated then Normal
coordinated bolus during 2 weeks then normal bolus during 2 weeks
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.




Primary Outcome Measures :
  1. postprandial glycaemia [ Time Frame: 2 hours after eating during 4 weeks ]
    measured by Self Monitoring of Blood Glucose


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229097


Locations
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France
University Hospital Toulouse Rangueil
Toulouse, Haute Garonne, France, 31059
Saint-André Hospital
Bordeaux, France, 33000
Lapeyronie Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Vincent Melki, Doctor University Hospital, Toulouse

Publications:
A. Farret, B. Catargi, J.P. Riveline, V. Melki, P. Schaepelynck, A. Sola, B. Guerci, H. Bertet, T. Mura, H. Chevassus, E. Renard : Étude randomisée contrôlée en cross-over comparant les effets sur le contrôle glycémique des bolus immédiats et combinés chez des patients diabétiques de type 1 traités par pompe à insuline portable. Diabetes & Metabolism, Volume 38, Supplement 2, March 2012, Page A6
Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010.
Etude Jubilé. SFD 2013
Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf
Melki.v, Cazals.l : Impact de la coordination des bolus et du débit de base sur le contrôle des glycémies postprandiales chez des diabétiques de type 1 traités par pompe externe (étude pilote). Poster accepté SFD 2014

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02229097     History of Changes
Other Study ID Numbers: 13 7029 08
2014-000969-47 ( EudraCT Number )
13-074 ( Other Grant/Funding Number: French Ministry of Health, PHRC 2013 )
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs