Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, continuous glucose sensor monitoring
Brief summary
The purpose of the study is to examine glycemic and neuropsychological outcomes in very young children with Type I diabetes who are being started on insulin pumps and to compare their outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be examined prior to and 12 months after the implementation of insulin pump therapy. These subjects will be recruited and followed because they are currently undergoing treatment for Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not be changed by the study team. Outcome measures will examine: glycemic outcomes (overall control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.
Interventions
None listed
Sponsors
Juvenile Diabetes Research Foundation
Indiana University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children with Type I diabetes: 2. Children must be 5 years of age or less at the time of entry into the study. 3. Children must have had a diagnosis of type I diabetes for at least 1 year at time of entry. 4. Children must be receiving two or more insulin injections daily.
Exclusion criteria
1. Children will be excluded if they have additional medical problems requiring treatment with agents known to affect blood glucose such as steroids or L-asparaginase. 2. Children must not have any other chronic illness in addition to diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HgBA1c | Baseline and 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insulin Pump Therapy | 21 |
| Insulin Injections | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Insulin Injections | Insulin Pump Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 21 Participants | 42 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.7 years STANDARD_DEVIATION 0.7 | 3.8 years STANDARD_DEVIATION 0.8 | 3.8 years STANDARD_DEVIATION 0.8 |
| Region of Enrollment United States | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Change in HgBA1c
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Pump Therapy | Change in HgBA1c | 8.5 percentage of glycosylated hemoglobin | Standard Deviation 0.6 |
| Insulin Injections | Change in HgBA1c | 8.7 percentage of glycosylated hemoglobin | Standard Deviation 0.7 |