An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)

Type 1 Diabetes Mellitus Clinical Trial

— IMPACT  

Official title:

Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232698
• Other study ID #: ADC-CI-APO-13019
• Status: Completed
• Phase: N/A
• First received: September 3, 2014
• Last updated: January 19, 2016
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyAustria: EthikkommissionGermany: Ethics CommissionGermany: German Institute of Medical Documentation and InformationNetherlands: Medical Ethics Review Committee (METC)Netherlands: Ministry of Health, Welfare and SportSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación ClínicaSweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with Type 1 diabetes for = 5 years

2. On their current insulin regimen for = 3 months prior to study entry

3. Screening HbA1c result = 7.5% (58 mmol/mol)

4. Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry

5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System

6. Aged 18 years or over.

Exclusion Criteria:

1. Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)

2. Subject is currently prescribed animal insulin

3. Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study

4. Has known allergy to medical grade adhesives

5. Currently participating in another device or drug study that could affect glucose measurements or glucose management

6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months

7. Currently using Sensor augmented pump therapy

8. Is planning to use a CGM device at any time during the study

9. A female subject who is pregnant or planning to become pregnant within the study duration

10. A breast feeding mother

11. Currently receiving dialysis treatment or planning to receive dialysis during the study

12. Has a pacemaker

13. Has experienced an acute myocardial infarction within previous 6 months

14. Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition

15. Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months

16. In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

Device:
• Sensor Based Glucose Monitoring System
Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
• Standard Blood Glucose Monitoring
Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.

Locations

Country	Name	City	State
Austria	VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie	Feldkirch
Austria	Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel	Graz
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Diakonissen-Krankenhaus Salzburg	Salzburg
Austria	Klinik fuer Innere Medizin III Medizinische Universitaet Wien	Wien
Austria	Wilhelminenspital Medzin 5	Wien
Germany	Diabetes Klinik Bad Mergentheim	Bad Mergentheim
Germany	Zentrum für Diabetologie Hamburg Bergedorf	Hamburg
Germany	Diabetes-Zentrum Hannover-Nord	Hannover
Germany	Diabetes Center Quakenbruck	Quakenbrück
Germany	Versdias GmbH	Sulzbach-Rosenberg
Netherlands	Onze Lieve Vrouwe gasthuis ( OLVG)	Amsterdam
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Medisch Centrum Haaglanden	Den Haag
Netherlands	Bethesda Diabetes Research Center	Hoogeveen
Netherlands	St. Antonius Ziekenhuis	Utrecht
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Clinica Diabetologica	Gijon
Spain	Servicio de Endocrinología Hospital Unversitario Cruces	Vizcaya
Sweden	Falu Lasarett	Falun
Sweden	Karolinska Universitetssjukhuset Solna	Solna
Sweden	Karolinska Universitetssjukhuset Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent <70mg/dL	Difference in time <70mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208	No
Secondary	HbA1c at 6 months	Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1	Baseline and Day 208	No
Secondary	Change in Time in Range at Day 45	Change is defined as time in range 70 - 180 mg/dL in days 31 -45 minus time in range at baseline (days 1- 15) in the intervention group	Baseline and Days 31 to 45	No
Secondary	HbA1c at 3 Months	Difference in HbA1c between intervention and control group at day 105 adjusting for baseline HbA1c at day 1	Baseline and 105 Days	No
Secondary	Mean Glucose	Difference in mean glucose between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208	No
Secondary	Glucose variability	Difference in continuous overall net glycaemic action (CONGA) (1, 2, 4 & 6 hour), standard deviation (SD) rate of change, (mean amplitude of glycaemic excursions) MAGE, mean of daily differences (MODD) , high blood glucose index (HBGI) , low blood glucose index (LBGI) post prandial glucose peak, time to peak, excursion and area under the curve (AUC) >180mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15). Post prandial glucose peak, time to peak, excursion and AUC>180mg/dL will be calculated during the 3 hours after each logged meal, for each subject and timeframe. Glucose excursion is change from meal time to peak glucose.	Baseline and Days 194 to 208	No
Secondary	Time spent and frequency < 40 mg/dL, <55mg/dL & <70mg/d and frequency of symptomatic hypoglycaemia	Difference in time and frequency < 40 mg/dL, <55mg/dL & <70mg/dL and frequency of symptomatic hypoglycaemia between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208	No
Secondary	Time spent and frequency > 180 mg/dL and > 240mg/dL	Difference in time > 180 mg/dL and > 240mg/dL(hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).	Baseline and Days 194 to 208	No
Secondary	Number of episodes of diabetic ketoacidosis (DKA), Hyperosmolar hyperglycaemic state (HHS) and severe hypoglycaemia.	The number of episodes of DKA, HHS and severe hypoglycaemia.will be summarised in the intervention and control group in each timeframe.	Baseline and Days 15 to 208	Yes
Secondary	Total daily dose of insulin (TDD)	Difference in TDD between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) TDD. TDD calculated from Reader uploads.	Baseline and Days 194 to 208	No
Secondary	Body weight, BMI, blood pressure and lipids at 6 Months	Difference in body weight, BMI blood pressure and lipids between intervention and control group assessed at day 194 adjusting for baseline (day 1).	Baseline (day 1) and Day 208	No
Secondary	User Questionnaire (Subject & HCP) at 6 Months	User questionnaire responses will be tabulated as number and percentage of subjects with each response. HCP questionnaire responses will be tabulated as number and percentage of HCPs with each response	Day 208	No
Secondary	Quality of Life	Includes hypoglycaemia fear survey (HFS), diabetes treatment satisfaction questionnaire (DTSQ), diabetes distress scale(DDS) & diabetes quality of life (DQoL) Difference in each score between intervention and control group assessed at day 194 adjusting for the corresponding score at baseline (day 1).	Baseline and Day 208	No
Secondary	Clinic time and medication usage	The number of emergency room visits, admissions, additional non protocol related clinic time and medication usage will be summarised in the intervention and control group in each timeframe (days 1-15 and days 15 -208).	Baseline (days 1 -15) and Days 15 to 208	No
Secondary	Number of glucose measurements performed	Difference in frequency (number per day) of blood glucose finger stick tests between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) frequency of finger stick tests performed. The frequency of sensor scans performed will be summarised in the intervention group in days 194 to 208.	Baseline and Days 194 to 208	No
Secondary	Adverse Events	The number of adverse events in days -30 to 208 will be tabulated as the number and percentage of subjects experiencing adverse events in the intervention and control groups, classified by seriousness, severity, relationship to the device and relationship to the study. Glycaemic adverse events will be classed separately.	Days -30 to 208	Yes
Secondary	Adverse Events at 1 Month	The number of adverse events in days -30 to 45 will be tabulated as the number and percentage of subjects experiencing adverse events in the intervention groups, classified by seriousness, severity, relationship to the device and relation to the study, Glycaemic adverse events will be classed separately.	Days -30 to 45	Yes
Secondary	Time in Range	Difference in time in range 70-180mg/dL between intervention and control group assessed in day 194 to 208 adjusting for baseline (days 1 to 15 time in range).	Baseline and Days 194 to 208	No
Secondary	Time spent & frequency <70mg/dL, 55mg/dL and 40 mg/dL	Difference in time and frequency <70 mg/dL, 55mg/dL and 40mg/dL (hours per day) between intervention and group group assessed in day 91 to 105 adjusting for baseline (days 1 to 15)	Baseline and Days 91 to 105	No
Secondary	Insulin ratio	Prandial to basal ratio summarised at Day 15 and Day 208	Baseline and Day 208	No
Secondary	Basal Insulin	Change in frequency of basal insulin doses summarised from baseline to day 208	Baseline and Day 208	Yes
Secondary	Mean Glucose	Difference in mean glucose between intervention and control group assessed in days 91 to 105 adjusting for baseline (days 1 to 15).	Baseline and Days 91 to 105	No
Secondary	Glucose variability	Difference in continuous overall net glycaemic action (CONGA) (1, 2, 4 & 6 hour), standard deviation (SD) rate of change, (mean amplitude of glycaemic excursions) MAGE, mean of daily differences (MODD) , high blood glucose index (HBGI) , low blood glucose index (LBGI) post prandial glucose peak, time to peak, excursion and area under the curve (AUC) >180mg/dL between intervention and control group assessed in days 91 to 105 adjusting for baseline (days 1 to 15). Post prandial glucose peak, time to peak, excursion and AUC>180mg/dL will be calculated during the 3 hours after each logged meal, for each subject and timeframe. Glucose excursion is change from meal time to peak glucose.	Baseline and Days 91 to 105	No