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Pediatr Diabetes. Author manuscript; available in PMC 2015 March 01.
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Pediatr Diabetes. 2014 March ; 15(2): 142–150. doi:10.1111/pedi.12065.

Family-based Psychoeducation and Care Ambassador

Intervention to Improve Glycemic Control in Youth with Type 1
Diabetes: A Randomized Trial
1 1 1
Michelle L. Katz, MD, MPH , Lisa K. Volkening, MA , Deborah A. Butler, MSW , Barbara
2 1
J. Anderson, PhD , and Lori M. Laffel, MD, MPH
1
Genetics and Epidemiology Section, Joslin Diabetes Center, 1 Joslin Place, Boston, MA, 02215
2
Department of Pediatrics, Baylor College of Medicine, 1102 Bates St. Suite 130, Houston, TX
77030

Abstract
Objective—Youth with type 1 diabetes frequently do not achieve glycemic targets. We aimed to
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improve glycemic control with a Care Ambassador (CA) and family-focused psychoeducational
intervention.
Research Design and Methods—In a 2-year, randomized, clinical trial, we compared 3
groups: 1) standard care, 2) monthly outreach by a CA, and 3) monthly outreach by a CA plus a
quarterly clinic-based psychoeducational intervention. The psychoeducational intervention
provided realistic expectations and problem-solving strategies related to family diabetes
management. Data on diabetes management and A1c were collected, and participants completed
surveys assessing parental involvement in management, diabetes-specific family conflict, and
youth quality of life. The primary outcome was A1c at 2 years; secondary outcomes included
maintaining parent involvement and avoiding deterioration in glycemic control.
Results—We studied 153 youth (56% female, median age 12.9 years) with type 1 diabetes
(mean A1c 8.4±1.4%). There were no differences in A1c across treatment groups. Among youth
with suboptimal baseline A1c ≥8%, more youth in the psychoeducation group maintained or
improved their A1c and maintained or increased parent involvement than youth in the other 2
groups combined (77% vs. 52%, p=.03; 36% vs. 11%, p=.01, respectively) without negative
impact on youth quality of life or increased diabetes-specific family conflict.
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Conclusions—No differences in A1c were detected among the 3 groups at 2 years. The
psychoeducational intervention was effective in maintaining or improving A1c and parent
involvement in youth with suboptimal baseline glycemic control.

Keywords
Type 1 Diabetes Mellitus; Patient adherence

Corresponding author: Lori M. Laffel, MD, MPH, lori.laffel@joslin.harvard.edu phone 617-732-2603, fax 617-309-2451 address:
Joslin Diabetes Center One Joslin Place Boston, MA 02215.
None of the authors has any relevant conflicts of interest.
Portions of this manuscript were presented at the 71st Scientific Sessions of the American Diabetes Association (2011).
 Katz et al. Page 2

Introduction
Contemporary type 1 diabetes management requires adherence to a complex daily
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therapeutic regimen. For youth with type 1 diabetes, this involves close collaboration
between the youth, the family, and the diabetes team. Unfortunately, research has
demonstrated that parent involvement diminishes (1;2), and glycemic control deteriorates
(3;4) over the course of childhood and adolescence for the majority of youth with type 1
diabetes.

Despite availability of insulin analogs and advanced treatment technologies such as insulin
pumps and continuous glucose monitors, most youth do not attain optimal targets for
glycemic control(5;6). Regular diabetes follow-up clinic visits have been shown to be
integral to good glycemic control (7). Additionally, parent involvement in diabetes
management is associated with better glycemic control in adolescents (8). Furthermore,
family-based behavioral interventions focused on family teamwork around diabetes
management have demonstrated positive impacts on glycemic outcomes (9;10).

We designed and evaluated a multi-faceted set of interventions targeting regular clinic

follow-up and family involvement. First, we used a nonmedical Care Ambassador (CA) to
facilitate care coordination for quarterly clinic visits and to enhance communication
between families and clinic staff between visits with monthly outreach(11;12); the Care
Ambassador did not provide any medical advice. Next, we created a family-focused
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teamwork intervention, adapted from our earlier validated interventions (9;10) aimed at
improving adherence to diabetes management through realistic expectations and problem-
solving strategies.

We designed a 3-arm, randomized, 2-year clinical study of youth with type 1 diabetes aimed
at assessing this multi-faceted set of interventions. We compared (1) standard care, which
included quarterly clinic visits facilitated by a CA (who assisted only with basic care
coordination by scheduling timely quarterly clinic visits), (2) monthly telephonic outreach
by a CA in addition to the basic quarterly visit-based care coordination and (3) a family-
focused and psychoeducational intervention provided at quarterly clinic visits in addition to
the monthly CA telephone outreach and the visit-based care coordination. We evaluated the
effects of the interventions on glycemic control, parent involvement in diabetes tasks, and
diabetes-specific family conflict.

Methods
Participants
Participants were recruited from a multidisciplinary pediatric diabetes program. Inclusion
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criteria were: youth age between 8-16 years, type 1 diabetes duration ≥6 months, and
established care at our center (as defined by ≥3 visits in the past 2 years or ≥2 visits in the
past year if diabetes duration was <1 year). Exclusion criteria included major psychiatric
illness, neuro-cognitive disability, another significant medical condition, or unstable living
environment as defined by department of social services or department of youth services
involvement. The Institutional Review Board approved the study protocol and parents/youth
provided written informed consent/assent before beginning any study procedures.

Eligible patients were recruited over a four-month period. One hundred seventy-four patients
were approached and 154 (89%) agreed to participate in the study. Of the 20 families who
declined, 16 families reported a lack of time or interest, two reported family problems, one had
concerns regarding privacy and one anticipated moving during the study. One participant was
excluded from data analyses because subsequent review revealed

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ineligibility; the participant had maturity onset diabetes of youth. Of the remaining 153
participants enrolled, 6 participants withdrew before the end of the study because they
moved or transferred their care. Another participant had repeated psychiatric
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hospitalizations; this participant’s data were truncated at the visit preceding the
hospitalizations. We conducted an intention-to-treat analysis with the last visit carried
forward for the 7 participants with incomplete follow-up. For those who completed the
study, the median follow-up time was 2.1 years (range 1.8-2.9 years). For the seven
participants with incomplete data, the median follow-up time was 0.9 years (range 0.3-1.1
years).

Participants were randomized in 2 strata according to age (8-12 years or ≥13 years) to one of
three groups: Standard Care (SC), Care Ambassador Plus (CA+), or Care Ambassador Ultra
(CA+Ultra). The interventions occurred in parallel. Participants provided demographic,
clinical, and laboratory evaluations at each visit. SC participants received usual pediatric
diabetes subspecialty care including basic care coordination by the Care Ambassador (to
assist in scheduling quarterly clinic visits). CA+ participants received monthly outreach by
the Care Ambassador via phone or email, in addition to the quarterly diabetes care and care
coordination given to the SC group. Finally, CA+Ultra participants received a
psychoeducational intervention conducted at quarterly study visits (see below), in addition
to monthly outreach and quarterly diabetes care and care coordination.
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A CA was a research assistant with a 4-year college degree and no medical background who
was trained in study protocol implementation and care coordination. The Care Ambassador
role included outreach to families toschedule clinic appointments or to relay family concerns
to medical providers (11;12). Care Ambassadors did not give medical advice. The CA also
delivered the psychoeducational intervention to the CA+Ultra group using a manualized
curriculum.

The psychoeducational intervention, adapted from our earlier validated materials (9;10),
consisted of a 30-minute session with participants and their parent/guardian on the day of a
regularly scheduled, quarterly clinic visit. The psychoeducational materials related to family
management of diabetes. The CA facilitated problem-solving exercises and role-playing of
realistic expectations for family teamwork. Senior study staff monitored the study integrity and
fidelity by review of taped intervention sessions. Session topics included: (1) Family teamwork
and communication; (2) Avoiding perfectionism and setting realistic goals; (3) Blood sugar
monitoring and A1C; (4) Avoiding family conflict related to diabetes; (5) Weight gain and
hypoglycemia awareness; (6) Decreasing feelings of burnout and isolation
(7) Sessions in review and (8) Research and technology update. Contact the authors for
further information about the psychoeducational intervention materials.
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Surveys
Youth and parents completed surveys at baseline, one year, and two years. Three families
completed only the initial survey assessment and their data were excluded from the analysis
of survey results. Three families completed only baseline and one year survey data and their
one year survey data were carried forward in the analysis.

Diabetes Family Responsibility Questionnaire—Youth and parents independently

completed the Diabetes Family Responsibility Questionnaire (DFRQ) (13) which measures
parental involvement in diabetes management tasks such as checking blood sugars. On this 17-
item questionnaire, participants chose between four response options on each item to rate who
had primary responsibility for each task (child/teen responsibility, equal responsibility, parent
responsibility and not applicable) with possible total scores ranging from 17-51, adjusting for
any missing items. Responses of ‘not applicable’ were scored the same as

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missing. Higher scores indicate more parental involvement. Youth and parent scores were
strongly correlated (R= 0.7, p<.0001) and so we used the mean of parent and youth scores
in our analyses.
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Diabetes Family Conflict Scale—Youth and parents independently completed the

validated revised Diabetes Family Conflict Scale (DFCS) (14) which measures diabetes-
specific family conflict regarding tasks such as remembering to check blood sugars or
scheduling doctor and dental visits. On this 19-item questionnaire, participants chose among
three response options (never argue, sometimes argue, always argue) with possible scores
ranging from 19-57. Higher scores indicate more conflict. Because parent and youth scores
were not strongly correlated (R=0.4, p<.0001), we present parent and youth scores
separately.

Pediatric Quality of Life Inventory—Generic Core Scales (PedsQL)—Youth and

parents completed the validated PedsQL—Generic Core Scales (15) (youth and parent
proxy versions) which measures youth health-related quality of life in two domains:
physical and psychosocial (includes emotional, school and social functioning). On this 23-
item questionnaire, respondents chose between five response options (never, almost never,
sometimes, often, almost always) to indicate how much an item had been a problem in the
past 1 month. Responses were linearly transformed and reverse-scored to produce a possible
total score range from 0-100. Higher scores indicate better youth health-related quality of
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life. Parent and youth scores were not strongly correlated (R=0.4, p<.0001), thus parent
proxy and youth scores are reported separately.

Outcome Variable: A1c

A1C was measured at routine quarterly visits by high performance liquid
chromatography (ref. range 4.0-6.0%; Tosoh 2.2, Tosoh Corp., Foster City, CA). In order
to look at the cumulative effect of the intervention over the time, we also looked at the
average A1c beginning at the third visit, corresponding to a median time enrolled of 6.6
months. This visit was selected as it followed the implementation of the
psychoeducational intervention for the Ca+Ultra group at visit 2.

Additional Variables
At study entry, parents provided demographic information and chart review yielded physical
exam and treatment information. Pubertal stage at entry reflected the most recent exam in
which pubertal staging was assessed. Pubertal stage was categorized into three categories
(prepubertal, pubertal, and post-pubertal). Body mass index (BMI) z-scores were calculated
according to standardized tables (16). The frequency of blood glucose monitoring was
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provided by clinician report at the clinical visit. Clinicians used a combination of glucose
data from the meter download and/or logbook to determine blood glucose monitoring
frequency. If clinician report was not available, participant report was used.

Statistical Analysis
Statistical analysis was performed using SAS version 9.2 (SAS Institute, Cary, NC). For the
baseline data and bivariate analyses, continuous variables were compared using unpaired T tests
or Wilcoxon rank sum depending upon the distribution of the data. Fisher Exact Test was used
for categorical analysis for 2×2 tables and chi-squared analyses were used with >2 categories.
Because the distribution of sex and race/ethnicity were significantly different among the groups,
multivariate analyses were adjusted for sex and race/ethnicity. We also adjusted for baseline
values of the outcome of interest in multivariate analyses. For continuous outcomes, MANOVA
was done using the Tukey method for multiple

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comparisons within the same model and means and standard deviations are presented.
Because of the unequal distribution of demographic characteristics among the groups, the
OBSMARGINS function was used to estimate the means. This provides estimates according
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to the actual proportions assigned to the groups instead of assuming a balanced distribution
among the groups. For binary outcomes, logistic regression was used and odds ratios and
associated p values are presented. Because past research has demonstrated deterioration in
adherence to diabetes management and glycemic control with increased duration of diabetes
and progression through adolescence (4;17), the proportion of participants that maintained
or improved their outcomes was evaluated using logistic regression.

Subgroup Analysis
We performed a subgroup analysis to evaluate those with suboptimal baseline glycemic
control (A1C ≥8%). An A1C ≥8% was defined as suboptimal because it is above the
American Diabetes Association goal for 6-12 year olds with diabetes (18). An additional
subgroup analysis was aimed at evaluating the effect of the psychoeducational intervention
in those with suboptimal glycemic control. Thus, SC and CA+ groups were combined into
one group designated SC/CA+ as these two groups did not receive the psychoeducational
intervention.

Results
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Overall, participants (N=153, 56% female) had a median age of 12.9 years (range 8.2-16.5),
median diabetes duration of 6.1 years (range 0.8-14.3), with 15% on 2 injections per day
and 85% on some form of intensive insulin therapy (see details in Table 1) and a mean A1c
8.4±1.4%. The three groups were comparable with regards to age, diabetes duration,
proportion on insulin pump, frequency of blood glucose monitoring, A1c, pubertal stage,
parental involvement in diabetes management, parent- and child-report of diabetes-specific
family conflict, and parent proxy-report and child self-report of youth QOL at baseline
(Table 2). There were statistically significant differences in sex and race/ethnicity between
the SC and CA+ groups, suggesting the need to adjust for these in the multivariate analyses.

Process of Care
The total number of diabetes follow-up visits for participants in the study generally met the
recommended every 3 months interval with 9.6±1.1 visits in the SC group, 9.0±1.7 visits in
the CA+ group, and 9.4±1.5 visits in the CA+Ultra group over a median of 2.1 years (range
0.3-2.9 years) of study participation. This supports the success of the basic care
coordination given to all 3 groups by the CA in ensuring recommended follow-up diabetes
care (and thereby matching for visit frequency among the three groups).
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One Year Study Outcomes

There were no differences among the groups at one year (Table 2).

Two Year Study Outcomes

In bivariate analyses, no differences were demonstrated among the 3 groups in glycemic
control (mean±SD of SC, CA+ and CA+Ultra: 8.5±1.3%, 9.0±1.7% and 8.6±1.3%,
respectively) at study end. Differences in sex and race/ethnicity may influence glycemic
outcomes (4;19) and thus we accounted for them in our multivariate analyses. Multivariate
analyses adjusting for sex, race/ethnicity, and baseline values of the outcome of interest
were similar to bivariate results and are presented in Table 2. There were also no differences
in the primary outcome of glycemic control after accounting for differences in baseline
values. There were no differences in diabetes-specific family conflict or youth quality of life

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among the three groups. The only significant difference among the groups was greater
parental involvement in CA+Ultra vs. CA+ (p=0.04).
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There were no differences in the odds of maintaining or improving A1c among the three
groups. Both the SC and CA+Ultra groups had greater odds of maintaining or increasing
the frequency of blood glucose monitoring versus the CA+ group (OR: 3.0; 95% CI 1.2-7.7
for SC vs CA+ and OR: 2.8; 95% CI 1.1-6.8 for CA+Ultra vs CA+). The CA+Ultra group
had almost 5 times the chance of maintaining or increasing parental involvement in diabetes
management at 2 years versus CA+ (OR: 4.9; 95% CI 1.6-15.6) and had a trend towards
increased odds maintaining or increasing parental involvement versus SC (OR 2.5; 95% CI
0.9-7.4).

Subgroup Analyses of Participants with Baseline A1c ≥8%

In order to determine the impact of the interventions in youth with the greatest need for
improvement, we performed a sub-analysis of participants with baseline A1c ≥8.0% (SC
n=28, CA+ n = 30, CA+Ultra n = 26). At baseline, this subgroup displayed similar unequal
distributions according to racial/ethnic minority status (SC 4%, CA+ 23%, and CA+Ultra
intermediate at 15%). Participants in CA+Ultra had greater odds of maintaining or
improving their A1c versus those in CA+ (OR 3.7, CI 1.1-12.7) with similar findings in the
comparison of CA+Ultra versus SC (OR 3.4, CI 1.0-11.9). Participants in CA+Ultra also
had greater odds of maintaining or improving parental involvement in diabetes management
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versus those in CA+ (OR 13.0, CI 2.0-83.3) and nonsignificantly greater odds versus SC
(OR 3.6, CI 0.8-15.6).

To assess the effects of the psychoeducational intervention in those with suboptimal baseline
glycemic control, we combined SC and CA+, as these two groups did not receive the
psychoeducational intervention. There were no significant differences between SC/CA+
(n=58) and CA+Ultra (n=26) in baseline characteristics (Table 3). There were also no
significant differences in the bivariate analyses of A1c, blood glucose monitoring frequency,
parental involvement, diabetes-specific family conflict, or youth quality of life. In bivariate
analyses, about 50% more participants in CA+Ultra than SC/CA+ maintained or improved
their A1c (77% vs. 52%, p=.03). In addition, more than three times as many families
maintained or increased their parental involvement in diabetes management in the CA+Ultra
group versus SC/CA+ groups (36% vs 11%, p=.03).

In multivariate analyses, there were not significant differences between the groups at one
year (Table 3). After 2 years, the adjusted A1C (mean±SD) in participants with initial A1c
≥8.0% was comparable (9.4±1.5 in SC/CA+ and 9.1±1.5 in CA+Ultra; Table 3). The odds of
maintaining or increasing blood glucose monitoring frequency did not differ between the
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groups (CA+Ultra vs SC/CA+ OR 1.1, 95% CI 0.4-3.1, Figure 1). The CA+Ultra group had
more than 3 times the odds of maintaining or improving their A1C versus the SC/CA+ group
(OR 3.6; 95% CI 1.2-10.8). The CA+Ultra group also had increased odds of maintaining or
increasing parental involvement (OR 6.2; 1.7-22.9). There was no difference in child- or
parent-reported diabetes-specific family conflict in the CA+Ultra group versus SC/CA+
groups associated with the increased family involvement. There were no differences in the
child’s quality of life as reported by parents or youth in CA+Ultra group versus SC/CA+
groups.

Discussion
In this three-arm, randomized clinical trial of gradations of care coordination with and
without a family-focused psychoeducational intervention, we achieved a uniform process of
care delivery with clinic visits at 3-4 month intervals as recommended by the American

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Diabetes Association (18). We anticipated that greater intensity of care coordination with or
without psychoeducation could improve A1c but we were unable to detect any differences
between the groups. Psychoeducation involving problem-solving, parent involvement in
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diabetes management, and setting realistic expectations for diabetes care did not yield
differences in glycemic outcomes in the entire sample. However, in subgroup analyses of
those with suboptimal baseline glycemic control, the psychoeducational intervention was
associated with maintained or improved A1c and maintained or increased parent
involvement in diabetes management tasks at 2 years although no differences were
detectable using continuous measures. Notably, the maintained involvement was not
associated with an increase in diabetes-specific family conflict.

Like previous studies at our center, this study utilized a CA to provide care coordination
(11;12). In an earlier study (12), those receiving care coordination by a CA had more clinic
visits and fewer episodes of severe hypoglycemia, emergency room visits and
hospitalizations than controls; the effect was greatest in those with poor baseline glycemic
control. In another study (11), the group receiving the psychoeducational intervention in
addition to care coordination from a CA demonstrated lower rates of hypoglycemia,
emergency department use, and hospitalization. In participants with poor glycemic control,
the psychoeducational intervention was significantly related to maintenance or
improvement in A1c.
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Since lay care coordination altered the process of care through improved clinic visit
frequency and decreased acute events in our clinic population, basic care coordination has
become standard of care in our clinic during the patient’s first year of clinic attendance.
Thus, the standard care group in our study incorporated some basic care coordination to
facilitate matching for attendance at clinic visits across study groups. This study aimed to
evaluate monthly outreach and monthly outreach supplemented by quarterly
psychoeducation. Our study suggests that monthly outreach does not lead to added benefit
when participants are already adherent to quarterly clinic visits. Another possibility is that in
the current era of alternative outlets for social support using community and technology-
based diabetes websites (20), monthly case management outreach does not offer unique
benefits to families. The psychoeducational intervention was also ineffective in the entire
population. This may demonstrate the difficulty of improving glycemic control through a
psychoeducational intervention in those youth that are already adherent to diabetes
management as demonstrated by their A1c. Alternatively, it could indicate that the quarterly
frequency of the intervention was not intense enough to impact behavior substantially in the
entire sample.

Consistent with our previous investigations validating the efficacy of family teamwork (9-
11), the current studies demonstrates maintenance or improvement in A1c in those youth
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receiving the psychoeducational intervention who had a suboptimal baseline A1c. However,
it is notable that there was not a significant absolute difference in A1c from baseline to 2
years in this group.Youth with suboptimal glycemic control remain at the highest risk for
acute (21) and chronic complications (22). In these youth, maintaining or improving
glycemic control was accompanied by avoiding diminished parent involvement in diabetes
management. Previous research has demonstrated both a decline in glycemic control (4;17)
and in family involvement in diabetes management (23) over the course of adolescence.

Parent involvement has been shown to be an important protective factor in promoting

diabetes adherence and glycemic control (24). Greater collaborative involvement by both
parents is correlated with better glycemic control and treatment adherence (8). Additionally,
parental supervision of diabetes-specific tasks is related to better adherence to diabetes
management in adolescents with diabetes (25). While such non-interventional research has

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suggested that maintaining parent involvement during adolescence is associated with better
adherence to diabetes management and better glycemic control, a number of interventional
studies of youth with type 1 diabetes performed outside of routine clinical care have had mixed
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results (26-28). Nonetheless, in a recent meta-analysis (29) of pediatric type 1 diabetes

interventional studies with adherence-promoting components, the authors note that, in general,
the effect of adherence-promoting interventions on glycemic control has been modest but can be
enhanced when the interventions target multiple processes such as family functioning and
problem-solving in addition to adherence. Our intervention targeted multiple processes such as
teamwork, problem-solving, and setting realistic expectations. In addition, our intervention
offered the ease of delivery at the time of routine clinic appointments and therefore may be less
expensive than alternatives that are not clinic-based.

Our study has three notable limitations. First, there were demographic imbalances among the
groups after randomization. Second, differences among the groups were only demonstrated in
post-hoc analyses. Third, we designed the study as a 3 group comparison rather than a 2×2
factorial design. A 2×2 factorial design would have allowed us to isolate the impact of the
psychoeducational intervention alone from the psychoeducational intervention combined with
monthly outreach, which the present design did not allow us to do. Future studies could
incorporate new research demonstrating the importance of effective parenting styles in diabetes
management (30) as well as approaches that incorporate both group visits and family sessions
since the latter may be promising in this age group (31). Future interventions could also use text
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messaging, message boards, and video conferencing as a means to intensify the intervention
without substantially increasing costs.

The current study is important in that it expands on our previous work (9-11) utilizing a
trained layperson to deliver a family-focused clinic-based psychoeducational intervention
for youth with type 1 diabetes and their families. Additionally, it demonstrates that monthly
outreach to patients with type 1 diabetes may not be beneficial when families already
demonstrate adherence to quarterly clinic visits. This randomized, low-cost, low intensity
intervention evaluated in a large cohort of youth with type 1 diabetes was able to
demonstrate limited efficacy in those with suboptimal glycemic control, suggesting this sub-
population as a promising target for future psychoeducational interventions. Notably, it is
this population of youth unable to achieve target A1c levels that remain at highest risk for
both acute and chronic diabetes complications. Despite recent technological advances both
in diabetes management and in communication modalities, improving adherence and
glycemic control remain important therapeutic targets for youth with type 1 diabetes and
their families.

Acknowledgments
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Lori Laffel, MD, MPH is the guarantor of this work. MLK conducted analyses, wrote manuscript, contributed to
discussion. BJA researched data, contributed to discussion, reviewed/edited manuscript. LKV researched data,
contributed to discussion, reviewed/edited manuscript. DAB researched data and contributed to discussion. LML
researched data, contributed to manuscript writing and discussion, reviewed/edited manuscript. Research support
from the Charles H. Hood Foundation, the Katherine Adler Astrove Youth Education Fund, the Maria Griffin Drury
Pediatric Fund, the Eleanor Chesterman Beatson Fund, NIH T32 DK 7260-35 to the Joslin Diabetes Center, Health
Resources and Services Administration grant T32 HP10018 to the Harvard Pediatric Health Services Research
Fellowship Program, K12 DK094721-02 to the Joslin Diabetes Center/Children’s Hospital Boston and grant
P30DK036836 to the Diabetes and Endocrinology Research Center.

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Figure 1.
Odds of Maintenance or Improvement in Selected Study Outcomes in those with Suboptimal
Baseline Glycemic Control, SC/CA+ (■) in Comparison with CA+Ultra ( ), * p=.02, # p=.
006.
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 Katz et al. Page 12

Table 1
Baseline Characteristics
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SC CA+ CA+Ultra
- (n=51) (n=52) (n=50)
Age (years) 12.5±2.3 13.4±2.4 12.7±2.2
Diabetes Duration (years) 5.7±3.5 6.8±3.2 6.5±3.8
A1C (%) 8.4 ±1.3 8.6±1.6 8.4±1.4
BG Monitoring (times/day) 3.8±1.3 3.8±1.3 3.8±1.0
zBMI (SDS) 0.6± 0.8 0.9±0.7 0.8±0.7
Percent Percent Percent

* 45 65 58
Sex (% female)
* 2 15 10
Race/Ethnicity (% non-white)
A1c ≥8% (%) 55 58 52
Insulin regimen (Injection Based) (%) 80 73 78
Pubertal Status (%)
Prepubertal 25 17 22
Pubertal 55 42 48
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Post-Pubertal 20 40 30
Highest Parental Education (%)
High School or Less 14 15 6
Some College 18 17 30
College Degree or More 69 67 64

Mean ± standard deviation presented.

*
p <.05 for difference between SC and CA+
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Table 2

Adjusted Baseline and 2 year Comparisons in the 3 groups

Katz et al.
Baseline 1 Year 2 Years
SC CA+ CA+Ultra SC CA+ CA+Ultra SC CA+ CA+Ultra
A1c (%) 8.5±1.4 8.5±1.4 8.3±1.4 8.6±0.9 8.7±0.9 8.5±0.9 8.6±1.0 8.8±1.0 8.6±1.0
Average A1c (%) 8.6±0.8 8.7±0.8 8.6±0.8
BG Monitoring 3.7±1.2 3.9±1.2 3.9±1.2 4.0±1.3 3.6±1.3 3.6±1.3 3.8±1.4 3.3±1.3 3.9±1.3
(x/day)
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Parent diabetes 36.3±4.8 35.0±4.8 36.6±4.7 35.2±3.0 34.2±3.0 34.6±2.9 33.2±3.4 32.1±3.4 33.8±3.3
#
involvement
Diabetes-specific family conflict
Parent report 24.1±3.9 24.4±3.8 24.3±3.8 25.2±4.4 24.8±4.4 25.5±4.4 25.2±4.3 24.1±4.3 25.6±4.1
Child report 24.4±5.1 25.4± 5.1 24.5±5.1 24.2±4.4 23.4±4.4 24.3±4.3 24.8±5.0 23.4±5.0 24.9±4.8
Child Quality of Life
Parent proxy 78.7±19.4 79.9±17.3 81.3±18.1 84.7±11.9 82.0±11.8 80.1±11.7 81.9±11.4 85.2±11.3 81.7±11.0
Child report 84.1±11.7 81.8±11.7 84.6±11.6 84.9±7.6 85.0±7.6 85.7±7.5 83.3±8.6 85.9±8.6 85.4±8.3

Means± standard deviation presented.

*
All values adjusted for race/ethnicity and sex, 1 and 2 year values adjusted for baseline value;
#
2 year comparison between CA+ and CA+Ultra, significant to p=0.04
Page Katz et al. Page 14
13

Table 3

Adjusted Baseline and 2 year Comparisons in those Not Receiving vs. Receiving the
Psychoeducational Intervention among Participants with Suboptimal Baseline Glycemic Control
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Baseline 1 Year 2 Years

SC/CA+ CA+Ultra SC/CA+ CA+Ultra SC/CA+ CA+Ultra

(n=58) (n=26)
A1c (%) 9.4±1.2 9.3±1.2 9.4±1.0 9.2±1.0 9.4±1.1 9.1±1.1
Average A1c (%) 9.4±0.9 9.2±0.9
BG Monitoring 3.6± 0.9 3.6±0.9 3.4±0.9 3.4±0.9 3.2±1.2 3.4±1.2
(times/day)
Parent diabetes 36.5±4.5 36.4±4.5 35.1±2.8 35.7±2.8 33.2±3.8 34.8±3.5
involvement
Diabetes-specific family conflict
Parent report 24.3±3.7 25.2±3.7 25.3±3.3 25.0±3.3 25.2±4.8 26.3±4.8
Child report 25.6±5.1 25.2±5.2 24.5±4.8 24.9±4.8 24.5±5.4 26.4±5.4
Child Quality of Life
Parent proxy 78.9±13.9 80.8±13.9 81.6±11.5 77.9±11.5 82.1±10.7 79.9±10.8
Child report 81.6±11.8 84.8±11.8 84.3±7.8 85.5±7.8 83.7±9.4 83.5±9.5
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