EAL

DM: Carbohydrate Management Strategies (2014)

Citation:

Trento M, Trinetta A, Kucich C, Grassi G, Passera P, Gennari S, Paganin V, Tedesco S, Charrier L, Cavallo F, Porta M. Carbohydrate counting improves coping ability and metabolic control in patients with type 1 diabetes managed by Group Care. J Endocrinol Invest. 2011; 34(2): 101-105. PubMed ID: 20440106

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To assess in patients with type 1 diabetes, the effects of adding a carbohydrate counting program (CCP) to continuing education by Group Care on coping ability, quality of life (QOL), knowledge of diabetes and metabolic control.

Inclusion Criteria:

Onset of diabetes before age of 30 (type 1 diabetes mellitus)
Start of insulin treatment within one year of diagnosis
Provided written informed consent.

Exclusion Criteria:

Not described.

Description of Study Protocol:

Design

Randomized control trial.

Blinding Used

Implied with measurements.

Intervention

Individuals were randomized to either a carbohydrate counting program group (CCP) or a control group without carbohydrate counting
In the carbohydrate counting program, group visits were held every three to four months by a doctor, nurse, dietitian and a psychologist
Each session included a welcome for the patient, teaching time, real-life situations and conclusions
Teaching strategies focused on facilitating learning while insisting on cognitive and psychomotor abilities (i.e., role-playing games)
Each patient received an educational support kit that included plastic food models of commonly consumed items.

Statistical Analysis

Descriptive data are shown as absolute frequencies of the different modalities for categorical data and as mean SD for continuous variables
Chi-square tests for categorical variables and T-tests for independent data were carried out to assess whether a significant difference could be evidenced between CCP and control groups at baseline
Differences between values at baseline and at final evaluation were tested with a T-test for dependent data
The differences between the CCP and control group following intervention were assessed by fitting a multivariate model where, for each variable, the difference between baseline and final values represented the dependent variable and treatment group
For all tests the significance level was set at alpha=0.05
All analyses were done using Stata 9.2.

Data Collection Summary:

Timing of Measurements

Quality of life, knowledge and coping ability were measured at baseline and after 30 months
Body weight, fasting blood sugar, HbA1c, insulin dosages and hypoglycemic episodes were measured at each visit, every three months
Total cholesterol, HDL cholesterol and triglycerides were measured yearly during routine visits.

Dependent Variables

Quality of life and coping were measured using three different questionnaires. Questionnaires included knowledge of diabetes, coping by the coping strategy indicator and an original quality of life questionnaire.
Body weight, fasting blood sugar, HbA1c, total and HDL cholesterol and triglycerides were measured using standard laboratory methods
Insulin dosages and hypoglycemic episodes were registered by the patients in a specific diary.

Independent Variables

Individuals were randomized to either a carbohydrate counting program group (CCP) or a control group without carbohydrate counting
In the carbohydrate counting program, group visits were held every three to four months by a doctor, nurse, dietitian and a psychologist
Each session included a welcome for the patient, teaching time, real-life situations and conclusions
Teaching strategies focused on facilitating learning while insisting on cognitive and psychomotor abilities (i.e., role-playing games)
Each patient received an educational support kit that included plastic food models of commonly consumed items.

Description of Actual Data Sample:

Initial N: 56 subjects (27 in CCP group, 29 in control group; 30 males, 26 females)
Attrition (final N): 56 subjects
Age: Mean age in CCP group was 37.33 years vs. 36.76 years in control group
Other relevant demographics: Duration of diabetes in CCP group was 22 years vs. 21.0 in the control group
Anthropometrics: Mean BMI (in kg/m²) in CCP group was 24.4 vs. 23.5 in the control group
Location: Italy.

Summary of Results:

Key Findings

QOL improved significantly (P<0.0001) in both CCP (88.7±9.2 vs. 78.0±9.9) and control patients (88.7±12.5 vs. 80.4±11.7) and by the end of the study, CCP subjects had better scores in knowledge (P<0.0001) and the three coping areas of problem solving (P<0.0001), social support seeking (P<0.005) and avoidance (P<0.005) than those in the control group
All variables showed a greater, although not statistically significant, improvement in patients with poor schooling
At 30 months, HbA1c was lower in the CCP group when compared to controls (7.2±0.9% vs. 7.9±1.4%, P<0.05)
There were no changes in body weight, BMI, fasting blood glucose, insulin dosage, hypoglycemic episodes, total cholesterol, HDL cholesterol or triglycerides, between or within groups.

Author Conclusion:

This study confirms that Group Care improves quality of life in people with type 1 diabetes, but suggests that specific educational and psychological supports are needed to modify adaptation to the disease. The CCP we developed appears effective in promoting change, especially in patients with low education.

Funding Source:

University/Hospital:

University of Turin, Turin Italy

Reviewer Comments:

Small numbers of subjects in groups.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		No
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	No
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes