N/A
Completed N=40
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
Type II Diabetes
Source: ClinicalTrials.gov NCT01698528 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Glycemic Control as Determined by the Change in Absolute HbA1c Level — -3.16; -2.00 Percent A1C
Summary
The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control as Determined by the Change in Absolute HbA1c Level |
-3.16; -2.00 | — |
| SECONDARY Number of Participants Reaching Target of HbA1c ≤ 7% |
8; 5 | — |
| SECONDARY Change in Average Participation Satisfaction |
10.1; 2.05 | — |
| SECONDARY Number of Participants With Hypoglycemia |
3; 1 | — |
| SECONDARY Time Health Care Providers and Subjects Spend on Managing the Insulin Titration |
108; 80 | — |
Eligibility Criteria
Inclusion:
- 18 years or older
- Has type 2 diabetes, starting on basal insulin therapy
- Hemoglobin A1c between 9-14%
- Has Wi-Fi internet connection at home
- Is willing to monitor blood glucose at least once per day
- Is willing to inject and self-titrate insulin dose
- Able to read and communicate in English proficiently
Exclusion:
- Has severe visual impairment impacting visual acuity
- Has severe hearing impairment impacting communication
- Has Type 1 diabetes
- Pregnant or lactating women
- Alcohol dependency
- Require multiple daily insulin injections
Data sourced from ClinicalTrials.gov (NCT01698528). 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.