AzTrials
AzTrials

Type 1 DiabetesPhase 4COBOLNCT02229097

Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

A Phase 4 study testing Normal bolus and Coordinated bolus in people with Type 1 Diabetes, run by University Hospital, Toulouse at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Normal bolus and Coordinated bolus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesFrance
Study dates
Oct 2014to Nov 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Basal infusion rate ≥ 0,5 Unit/h
  • Self-monitoring of blood glucose frequency > 4/days
  • Aware of hypoglycaemia

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Saint-André Hospital

    Bordeaux, 33000

  • Lapeyronie Hospital

    Montpellier, 34295

  • University Hospital Toulouse Rangueil

    Toulouse, Haute Garonne, 31059

Other trials in France

About this study

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

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
Type 1 Diabetes
Being tested
Normal bolus, Coordinated bolus
Keywords
type 1 diabetes
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02229097
Study groupRoleWhat they receive
Normal then CoordinatedExperimentalnormal bolus during 2 weeks then coordinated bolus during 2 weeks
Receives: Drug: Normal bolus; Drug: Coordinated bolus
Coordinated then NormalExperimentalcoordinated bolus during 2 weeks then normal bolus during 2 weeks
Receives: Drug: Normal bolus; Drug: Coordinated bolus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postprandial glycaemia

    measured by Self Monitoring of Blood Glucose

    Measured: 2 hours after eating during 4 weeks

Secondary outcomes (16)

  1. adverse events

    Measured: Throughout the study (4 weeks)

  2. severe hypoglycaemia frequency

    Measured: Throughout the study (4 weeks)

  3. insulin doses

    Measured: basal rate and boluses

  4. mean glycaemia

    data from Self Monitoring of Blood Glucose

    Measured: before eating and 2 hours after eating during 4 weeks

  5. standard deviation of glycaemia

    data from Self Monitoring of Blood Glucose

    Measured: before eating and 2 hours after eating during 4 weeks

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

    data from Self Monitoring of Blood Glucose

    Measured: before eating and 2 hours after eating during 4 weeks

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

    data from Self Monitoring of Blood Glucose

    Measured: before eating and 2 hours after eating during 4 weeks

  8. frequency of glycaemia >140mg/dl

    data from Self Monitoring of Blood Glucose

    Measured: before eating and 2 hours after eating during 4 weeks

  9. mean glycemia

    data from Continue Glycemia Monitoring

    Measured: Throughout the day during 4 weeks

  10. standard deviation

    data from Continue Glycemia Monitoring

    Measured: Throughout the day during 4 weeks

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

    data from Continue Glycemia Monitoring

    Measured: Throughout the day during 4 weeks

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

    data from Continue Glycemia Monitoring

    Measured: Throughout the day during 4 weeks

  13. time spent within glucose range mg/dl

    data from Continue Glycemia Monitoring

    Measured: Throughout the day during 4 weeks

  14. fructosamine

    Measured: day 1

  15. fructosamine

    Measured: day 1 + 2 weeks

  16. fructosamine

    Measured: day 1 + 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02229097
Sponsor's protocol ID
13 7029 08
Other IDs
2014-000969-47, 13-074, 2014
Acronym
COBOL
Status last verified
Jul 2016
First submitted
26 Aug 2014
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20046653

  • 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.

  • 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.

    PubMed 8366922

  • 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.

    PubMed 16371630

  • Etude Jubilé. SFD 2013

  • 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.

    PubMed 11909787

  • 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.

    PubMed 10480516

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Normal bolus and Coordinated bolus in people with Type 1 Diabetes, run by University Hospital, Toulouse at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postprandial glycaemia (time frame: 2 hours after eating during 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02229097, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in