An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT) (IMPACT)
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| ClinicalTrials.gov Identifier: NCT02232698 |
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Recruitment Status :
Completed
First Posted : September 5, 2014
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 1 Diabetes Mellitus | Device: Sensor Based Glucose Monitoring System Device: Standard Blood Glucose Monitoring | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 328 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes |
| Study Start Date : | September 2014 |
| Actual Primary Completion Date : | October 2015 |
| Actual Study Completion Date : | October 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sensor Based Glucose Monitoring System
Standard sensing system use for 6 months.
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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). |
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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.
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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). |
- 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).
- 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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232698
Show 23 study locations
| Principal Investigator: | Stephan Matthaei | Diabetes Center Quakenbruck |
| Responsible Party: | Abbott Diabetes Care |
| ClinicalTrials.gov Identifier: | NCT02232698 |
| Other Study ID Numbers: |
ADC-CI-APO-13019 |
| First Posted: | September 5, 2014 Key Record Dates |
| Results First Posted: | April 10, 2017 |
| Last Update Posted: | April 10, 2017 |
| Last Verified: | February 2017 |
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Sensing Technology Type 1 Diabetes, |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Hypoglycemia Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |