N/A
Completed N=75
Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01718522 ↗
Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months — 1.26; 0.98 excursions — p=0.001
Summary
The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP) therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps and continuous glucose monitoring systems in Germany.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months |
1.26; 0.98 | 0.001 sig |
| SECONDARY Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months |
0.19; 0.16 | 0.12 |
| SECONDARY Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months |
7.96; 7.90 | 0.30 |
| SECONDARY Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months |
154.80; 159.06 | 0.03 sig |
| SECONDARY Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months |
5.6; 5.01 | 0.04 sig |
| SECONDARY Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months |
0.07; 0.028 | 0.35 |
| SECONDARY Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months |
1.32; 1.79 | 0.001 sig |
| SECONDARY Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months |
737.62; 771.00 | 0.61 |
| SECONDARY Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months |
0.62; 0.73 | 0.1 |
| SECONDARY Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months |
0.22; 0.25 | 0.22 |
| SECONDARY Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months |
— | — |
Eligibility Criteria
Inclusion Criteria
- patients with signed informed consent
- Type 1 DM and has been on insulin pump therapy for at least 3 months prior to signature of the informed consent
- patients use CGM component as part as part of the continuous subcutaneous insulin infusion (CSII) therapy for a minimum of 1 month
Exclusion Criteria
- participation in any other trial
- any disease or drug treatment that can interfere with the outcome of sensor usage
- using CGM in CSII < 3 days/week
- patients not willing to sign informed consent
- abuse of alcohol or drugs (exception of nicotine consumption)
- eating disorder, anorexia, bulimia or other mental disorders
Data sourced from ClinicalTrials.gov (NCT01718522). 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.