NCT01173991

Brief Summary

The investigators postulate that carbohydrate (CHO) counting in adult patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) may improve glycemic control, glycemic variability and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
Last Updated

August 3, 2010

Status Verified

July 1, 2010

Enrollment Period

11 months

First QC Date

July 26, 2010

Last Update Submit

August 2, 2010

Conditions

Diabetes Mellitus, Type 1Insulin Pump, Programmable

Keywords

carbohydrate countingcontinuous subcutaneous insulin infusiontype 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Glycated haemoglobin (HbA1c)

    6 months

Secondary Outcomes (7)

  • Fasting glucose

    6 months

  • Glycemic variability (mean, sd, min, max, variability range, BG in target range, LBGI, HBGI) based on capillary glucose data

    6 months

  • Daily insulin requirement (basal daily requirement, bolus daily requirement, total daily requirement)

    6 months

  • Body Mass Index (BMI)

    6 months

  • Waist circumference

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Carbohydrate counting

EXPERIMENTAL

This group received carbohydrate counting training

Behavioral: Carbohydrate counting training

Controls

NO INTERVENTION

This group received standard education

Behavioral: Carbohydrate counting training

Interventions

Carbohydrate counting trainingBEHAVIORAL

Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.

Carbohydrate countingControls

Eligibility Criteria

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

You may qualify if:

  • type 1 diabetes mellitus
  • age 18-65
  • continuous subcutaneous insulin infusion for at least 3 months

You may not qualify if:

  • patients who have already been trained in carbohydrate counting
  • known hypothyroidism not on replacement therapy
  • renal disease (serum creatinine \>1.4 mg/dl in females and \>1.7 mg/dl in males)
  • patients with celiac disease
  • pregnancy
  • serious diseases or disabilities which may interfere with study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

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

  • Emanuele Bosi, MD

    San Raffaele Scientific Institute, Milano Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2010

First Posted

August 3, 2010

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Study Completion

January 1, 2010

Last Updated

August 3, 2010

Record last verified: 2010-07

Locations

IT(1)