An observational study in Type 1 Diabetes, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Indiana University · Observational
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.
3,523 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 42 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children diagnosed with type 1 diabetes for at least one year at the time of study. In addition, children must be under the age of 5 years
Exclusion Criteria:
Children starting insulin pump therapy
Children remaining on insulin injections.
Change in HgBA1c
Time frame: Baseline and 6 months
| Milestone | Insulin Pump Therapy | Insulin Injections |
|---|---|---|
| Started | 21 | 21 |
| Completed | 20 | 17 |
| Not completed | 1 | 4 |
| percentage of glycosylated hemoglobin | Insulin Pump Therapy | Insulin Injections |
|---|---|---|
| Change in HgBA1c | 8.5 ± 0.6 | 8.7 ± 0.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Pump Therapy | — | 0/21 (0%) | 0/21 (0%) |
| Insulin Injections | — | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Insulin Pump Therapy | Insulin Injections | Total |
|---|---|---|---|
| <=18 years | 21 | 21 | 42 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Insulin Pump Therapy | Insulin Injections | Total |
|---|---|---|---|
| Mean | 3.8 ± 0.8 | 3.7 ± 0.7 | 3.8 ± 0.8 |
| Sex: Female, Male(Participants) | Insulin Pump Therapy | Insulin Injections | Total |
|---|---|---|---|
| Female | 11 | 14 | 25 |
| Male | 10 | 7 | 17 |
| Region of Enrollment(participants) | Insulin Pump Therapy | Insulin Injections | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Indiana University