NCT02229097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

August 26, 2014

Last Update Submit

February 21, 2017

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • postprandial glycaemia

    measured by Self Monitoring of Blood Glucose

    2 hours after eating during 4 weeks

Secondary Outcomes (16)

  • adverse events

    Throughout the study (4 weeks)

  • severe hypoglycaemia frequency

    Throughout the study (4 weeks)

  • insulin doses

    basal rate and boluses

  • mean glycaemia

    before eating and 2 hours after eating during 4 weeks

  • standard deviation of glycaemia

    before eating and 2 hours after eating during 4 weeks

  • +11 more secondary outcomes

Study Arms (2)

Normal then Coordinated

EXPERIMENTAL

normal bolus during 2 weeks then coordinated bolus during 2 weeks

Drug: Normal bolusDrug: Coordinated bolus

Coordinated then Normal

EXPERIMENTAL

coordinated bolus during 2 weeks then normal bolus during 2 weeks

Drug: Normal bolusDrug: Coordinated bolus

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 then NormalNormal then Coordinated
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.

Coordinated then NormalNormal then Coordinated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • known impaired renal function (creatinin clearance \<60ml/min)
  • Gastroparesis
  • Serious or instable disease likely to induce a glycaemic control deterioration - treatment with corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Toulouse Rangueil

Toulouse, Haute Garonne, 31059, France

Location

Saint-André Hospital

Bordeaux, 33000, France

Location

Lapeyronie Hospital

Montpellier, 34295, France

Location

Related Publications (10)

  • Bondia J, Dassau E, Zisser H, Calm R, Vehi J, Jovanovic L, Doyle FJ 3rd. Coordinated basal-bolus infusion for tighter postprandial glucose control in insulin pump therapy. J Diabetes Sci Technol. 2009 Jan;3(1):89-97. doi: 10.1177/193229680900300110.

    PMID: 20046653BACKGROUND

  • 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

    BACKGROUND

  • Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010.

    BACKGROUND

  • Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

    PMID: 8366922BACKGROUND

  • Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.

    PMID: 16371630BACKGROUND

  • Etude Jubilé. SFD 2013

    BACKGROUND

  • Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ. 2002 Mar 23;324(7339):705. doi: 10.1136/bmj.324.7339.705.

    PMID: 11909787BACKGROUND

  • Mudaliar SR, Lindberg FA, Joyce M, Beerdsen P, Strange P, Lin A, Henry RR. Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diabetes Care. 1999 Sep;22(9):1501-6. doi: 10.2337/diacare.22.9.1501.

    PMID: 10480516BACKGROUND

  • Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf

    BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Vincent Melki, Doctor

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 29, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 23, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)