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NCT03138447: DHIT
A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group
NA trial testing Basal Insulin Titration Application in Diabetes Mellitus, Type 2 in 30 participants. Completed in 30 January 2019.
30 January 2019
Quick facts
| Lead sponsor | Amalgam Rx, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 30 March 2017 |
| Primary completion | 30 January 2019 |
| Estimated completion | 30 January 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Basal Insulin Titration Application
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Amalgam Rx, Inc.
Who can join
21 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The digital health tool is an application ("app") available on iOS and Android enabled mobile phones. Health Care Providers ("HCPs") configure algorithms which can be tailored to individual patient's needs and then prescribe the app to support optimal basal insulin titration and dosing. In this study, participants will be recruited from a medical practice in which an HCP has prescribed a once-daily basal insulin. Participants will be trained on the use of the app utilizing their own mobile phone. During training, a brief self-assessment survey will be administered. After 90 days of usage, a telephone survey will be conducted. The baseline A1C results and the end of study A1C results will be collected from the patients' routine clinical care records. Data from the retrospective control group will be collected from a chart review of the same practice.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03138447
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
- NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03138447 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amalgam Rx, Inc.
- Last refreshed: 13 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03138447.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing