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NCT03249974
Comparison Between Enlite and Flash Glucose Monitoring
trial testing Enlite sensor communicating with Minimed 640G pump in Type1 Diabetes Mellitus in 20 participants. Completed in 4 July 2018.
4 July 2018
Quick facts
| Lead sponsor | Jessa Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 5 July 2017 |
| Primary completion | 4 July 2018 |
| Estimated completion | 4 July 2018 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Enlite sensor communicating with Minimed 640G pump
Conditions studied
- Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →
Sponsor
Jessa Hospital
Who can join
Adults 5 to 18, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose. 2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month. 3. The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena. 4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within target,% under target, amount of hypoglycemia) in the month prior to sensor switching will be compared to the same data recorded by the Enlite sensor during the first month of use.
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 NCT03249974
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type1 Diabetes Mellitus
Currently open trials in the same condition.
- NCT03945747 — MEtabolic and Renal Effects of AutoMAted Insulin Delivery Systems in Youth With Type 1 Diabetes Mellitus · active not recruiting
- NCT03369821 — EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study) · recruiting
- NCT03811470 — China Diabetes Registry by Metabolic Management Center · recruiting
Other Jessa Hospital trials
Trials by the same sponsor.
- NCT07483775 — Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Sur · NA · not yet recruiting
- NCT06881602 — Remote Clinical Monitoring After Robotic Distal Pancreatectomy · NA · not yet recruiting
- NCT07010055 — Using Digital Health in a Postoperative Setting After Major Surgery: Semi-structured Interview Study · NA · not yet recruiting
- NCT07010081 — Using Digital Health in a Postoperative Setting After Major Surgery: Survey Study · NA · recruiting
- NCT07482267 — Evaluation of Patients Suffering From Polytrauma Admitted to the ICU · active not 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 NCT03249974 (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 Jessa Hospital
- Last refreshed: 11 July 2018
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/NCT03249974.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing