N/A
Completed N=11
Continue Glucose Monitoring Before Insulin Pump
Source: ClinicalTrials.gov NCT02813421 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) — 81.7; 68.0 Percentage of time
Summary
The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) |
81.7; 68.0 | — |
| SECONDARY Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL) |
71; 57.5 | — |
| SECONDARY Mean Blood Glucose (mg/dL) |
137; 193 | — |
| SECONDARY Percentage Time Hyperglycemic |
13.7; 31.7 | — |
| SECONDARY Total Daily Insulin Dose (Units) |
0.88; 0.87 | — |
| SECONDARY Percentage Basal Insulin (%) |
34.5; 27.5 | — |
| SECONDARY Total Number of Insulin Dose Adjustments |
18.7; 12.7 | — |
| SECONDARY Total Number of Phone Calls to Clinic Hotline |
8.33; 5.67 | — |
| SECONDARY Number of Insulin Dose Adjustments Made Per Phone Call |
2.39; 1.96 | — |
| SECONDARY Episodes of DKA |
0; 0 | — |
| SECONDARY Total Number of Episodes of Severe Hypoglycemia |
0; 0 | — |
| SECONDARY Hemoglobin A1c (%) |
-0.27; 0.025 | — |
| SECONDARY Number of Participants With Satisfaction of Transition to Pump Therapy |
3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Males and Females aged 2-24 years
- Clinical diagnosis of Type 1 diabetes mellitus
- Duration of diabetes: At least 6 months
- This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.
- Basal/bolus insulin regimen using long-acting and rapid-acting insulin
- This will provide a uniform method of insulin therapy.
- Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
- Willingness to wear the iPro®2 for 5 days continuously per insertion
- Participant agrees to comply with the study protocol requirements
- Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian
Exclusion Criteria
- Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
- Glucocorticoid use within 2 weeks of study enrollment
- Concurrent use of other medications that may affect glycemic control
- Prior CGM use in the past 6 months
- The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
- Non-English or non-Spanish speaking
Data sourced from ClinicalTrials.gov (NCT02813421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.