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An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) (IMPACT)
This study has been completed.
Sponsor:
Abbott Diabetes Care
Information provided by (Responsible Party):
Abbott Diabetes Care
ClinicalTrials.gov Identifier:
NCT02232698
First received: September 3, 2014
Last updated: February 27, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Type 1 Diabetes Mellitus | Device: Sensor Based Glucose Monitoring System Device: Standard Blood Glucose Monitoring |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Other |
| Official Title: | Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Dextrose
U.S. FDA Resources
Further study details as provided by Abbott Diabetes Care:
Primary Outcome Measures:
- Time Spent <70 mg/dL [ Time Frame: Baseline and Days 194 to 208 ]Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
Secondary Outcome Measures:
- HbA1c at 6 Months [ Time Frame: Baseline and Day 208 ]Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
- Time Spent <55 mg/dL and <40 mg/dL [ Time Frame: Baseline and Days 194 to 208 ]Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
- Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL [ Time Frame: Baseline and Days 194-208 ]Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
- Time Spent >180 mg/dL and >240 mg/dL [ Time Frame: Baseline and Days 194 to 208 ]Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
- Time in Range [ Time Frame: Baseline and Days 194 to 208 ]Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).
- Number of Glucose Measurements Performed [ Time Frame: Days 1 to 208 ]Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.
- System Utilisation [ Time Frame: Days 15 to 208 ]System utilisation assessed by percentage of sensor glucose data collected by the intervention group
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208 [ Time Frame: Baseline and Day 208 ]
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).
The ANCOVA adjusts for baseline DTSQs (status version).
| Enrollment: | 328 |
| Study Start Date: | September 2014 |
| Study Completion Date: | October 2015 |
| Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sensor Based Glucose Monitoring System
Standard sensing system use for 6 months.
|
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 (Sensor glucose measurements not visible during this time). |
|
Active Comparator: Standard Blood Glucose Monitoring
Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
|
Device: 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 (Sensor glucose measurements not visible during this time). All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time). |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosed with Type 1 diabetes for ≥ 5 years
- On their current insulin regimen for ≥ 3 months prior to study entry
- Screening HbA1c result ≤ 7.5% (58 mmol/mol)
- 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
- In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
- Aged 18 years or over.
Exclusion Criteria:
- 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)
- Subject is currently prescribed animal insulin
- Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
- Has known allergy to medical grade adhesives
- Currently participating in another device or drug study that could affect glucose measurements or glucose management
- Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
- Currently using Sensor augmented pump therapy
- Is planning to use a CGM device at any time during the study
- A female subject who is pregnant or planning to become pregnant within the study duration
- A breast feeding mother
- Currently receiving dialysis treatment or planning to receive dialysis during the study
- Has a pacemaker
- Has experienced an acute myocardial infarction within previous 6 months
- 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
- Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
- In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02232698
Please refer to this study by its ClinicalTrials.gov identifier: NCT02232698
Locations
| Austria | |
| VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie | |
| Feldkirch, Austria, 6807 | |
| Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel | |
| Graz, Austria, 8036 | |
| Medizinische Universität Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Diakonissen-Krankenhaus Salzburg | |
| Salzburg, Austria, 5020 | |
| Klinik fuer Innere Medizin III Medizinische Universitaet Wien | |
| Wien, Austria, 1090 | |
| Wilhelminenspital Medzin 5 | |
| Wien, Austria, 1160 | |
| Germany | |
| Diabetes Klinik Bad Mergentheim | |
| Bad Mergentheim, Germany, 97980 | |
| Zentrum für Diabetologie Hamburg Bergedorf | |
| Hamburg, Germany, 21029 | |
| Diabetes-Zentrum Hannover-Nord | |
| Hannover, Germany, 30165 | |
| Diabetes Center Quakenbruck | |
| Quakenbrück, Germany, 49610 | |
| Versdias GmbH | |
| Sūlzbach-Rosenberg, Germany, 92237 | |
| Netherlands | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1007 MB | |
| Onze Lieve Vrouwe gasthuis ( OLVG) | |
| Amsterdam, Netherlands, 1090 HM | |
| Amphia Ziekenhuis | |
| Breda, Netherlands, 4800 RK | |
| Medisch Centrum Haaglanden | |
| Den Haag, Netherlands, 2512 VA | |
| Bethesda Diabetes Research Center | |
| Hoogeveen, Netherlands, 7909 AA | |
| St. Antonius Ziekenhuis | |
| Utrecht, Netherlands, 3543 AZ | |
| Spain | |
| Hospital Germans Trias i Pujol | |
| Badalona, Spain, 8916 | |
| Clinica Diabetologica | |
| Gijon, Spain, 33206 | |
| Servicio de Endocrinología Hospital Unversitario Cruces | |
| Vizcaya, Spain, 48903 | |
| Sweden | |
| Falu Lasarett | |
| Falun, Sweden, SE-791 29 | |
| Karolinska Universitetssjukhuset Solna | |
| Solna, Sweden, SE-171 76 | |
| Karolinska Universitetssjukhuset Huddinge | |
| Stockholm, Sweden, SE-141 86 | |
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
| Principal Investigator: | Stephan Matthaei | Diabetes Center Quakenbruck |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Abbott Diabetes Care |
| ClinicalTrials.gov Identifier: | NCT02232698 History of Changes |
| Other Study ID Numbers: |
ADC-CI-APO-13019 |
| Study First Received: | September 3, 2014 |
| Results First Received: | January 6, 2017 |
| Last Updated: | February 27, 2017 |
Keywords provided by Abbott Diabetes Care:
|
Sensing Technology Type 1 Diabetes, |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Hypoglycemia Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on July 26, 2017