Glycaemic control and prevention of hypoglycaemia in intensively treated subjects with type 1 diabetes using Accu-Chek® advisor insulin guidance software
| ISRCTN | ISRCTN66986330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66986330 |
| Secondary identifying numbers | 03-0834 |
- Submission date
- 31/10/2007
- Registration date
- 06/11/2007
- Last edited
- 24/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Tevin Bookout
Scientific
Scientific
1775 N. Ursula Street
Aurora
80045
United States of America
| tevin.bookout@uchsc.edu |
Study information
| Study design | Open-label randomised controlled trial involving 123 subjects with type 1 diabetes on multiple daily injections |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Glycaemic control and prevention of hypoglycaemia in intensively treated subjects with type 1 diabetes using Accu-Chek® advisor insulin guidance software |
| Study acronym | N/A |
| Study objectives | Improvement in glucose control by at least 0.4% reduction in haemoglobin A1c (HbA1c) values in subjects using insulin guidance software at 6 months and 1 year. |
| Ethics approval(s) | Ethics approval received from the Colorado Multiple Institution Review Board (COMIRB) University of Colorado at Denver Health Sciences Center, first on the 13th December 2004, and thereafter annual reviewed by COMIRB (ref: 04-0834). |
| Health condition(s) or problem(s) studied | Type 1 Diabetes |
| Intervention | The primary outcome of this study was predefined as a reduction in HbA1c value of more than 0.4% in the experimental group. Subjects randomised to the experimental group received a Personal Digital Assistant (PDA) loaded with the insulin guidance software. At baseline (visit 1), a healthcare provider and/or Certified Diabetes Educator (CDE) reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The software program allowed the healthcare provider to enter demographic data such as age, height and weight which could potentially affect the insulin sensitivity factor already programmed into the device. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for Self Monitored Blood Glucose (SMBG) testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event. All the data from the glucose meters and the PDAs were downloaded at every visit. Glucose values were captured in one of the following categories to assess target glycaemia and pie charts were created. Within Target Range (WTR) glucose values were those between 70 - 150 mg/dL (3.89 to 8.33 mmol/L). Below Target Range (BTR) glucose values were defined as 69 mg/dL (3.83 mmol/L) and Above Target Range (ATR) glucose values were those values above 150 mg/dL (8.33 mmol/L). These glucose levels were chosen based on our previous research on SMBG downloads. Hypoglycaemia: Hypoglycaemia was defined as glucose values of 59 mg/dL (3.27 mmol/L). Severe hypoglycaemia was defined as subjects needing assistance as previously described by DCCT Research Group. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure | Improvement in glucose control by at least 0.4% reduction in HbA1c values in subjects using insulin guidance software at 6 months and 1 year. |
| Secondary outcome measures | Secondary outcomes were measured at each of the clinic visits given below for: 1. Hypoglycaemia 2. Weight gain 3. Insulin dose 4. Frequency of self monitoring of blood glucose, within, above and below the target range glycaemia (70 - 150 mg/dL) All subjects were asked to attend seven in-clinic visits (baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months) and participate in three telephone visits (4.5 months, 7.5 months, 9.5 months) throughout the course of the study. Data for blood glucose values, testing frequency, hyperglycaemic excursions, hypoglycaemic events (all, nocturnal, and severe), insulin dose, weight and BMI, hospitalisations, emergency room visits and illnesses were recorded at each in clinic visit. All subjects completed a patient satisfaction questionnaire and the experimental group also completed an Advisor questionnaire. As part of their routine clinical care, any additional phone visits were equally encouraged in both groups. |
| Overall study start date | 07/01/2005 |
| Completion date | 05/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 123 |
| Key inclusion criteria | 1. Adult - male or female, 18 to 60 years of age 2. Diagnosed with Type 1 diabetes mellitus at least six months 3. HbA1c greater than 7.5% and less than 11.0% at screening 4. Insulin dose 0.5 - 2.0 units/kg 5. Hematocrit between 25% and 65% 6. Weight 100 - 300 pounds 7. On a dual insulin therapy supported by Accu-Chek® insulin advisor software 8. On a "day shift" schedule (typical day begins before noon) 9. Willing to perform a minimum of three blood glucose tests per day - before breakfast, before lunch, and before dinner (standard of care) 10. Willing to complete at least 7 clinic visits in 12 months (baseline, 2-week, 6-week, 3-month, 6-month, 9-month, and 12-month) 11. Willing to complete three study phone calls conducted by study coordinator (4.5-month, 7.5-month and 10.5-month) 12. Able and willing to provide written informed consent to participate 13. Willing to comply with the study protocol 14. Willing to be randomised into either the control group or the experimental group |
| Key exclusion criteria | 1. On insulin pump therapy 2. On oral, inhaled or pre-mixed insulin 3. Engaged in a minimum of 30 minutes of cardiovascular (aerobic) exercise 5 days out of a 7-day week 4. Conditions that can cause significant increase of the insulin sensitivity factor, such as a steroid therapy, diabetic ketosis, insulin-resistant syndrome 5. Creatinine greater than 2.5 mg/dl, renal transplantation or currently undergoing kidney dialysis 6. Pregnant or intends to become pregnant during the course of the study 7. Undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer 8. Plan to travel to a different time zone more than three times per month 9. Clinical signs or symptoms of liver disease such as jaundice 10. Diagnosis of acute or chronic hepatitis 11. Diagnosis of haemoglobinopathy or chronic anaemia 12. Severe unexplained hypoglycaemia in the past 3 months that required Emergency Department (ED) admission 13. Participation in another clinical trial in the past 1 month 14. Weight under 100 pounds or over 300 pounds |
| Date of first enrolment | 07/01/2005 |
| Date of final enrolment | 05/01/2007 |
Locations
Countries of recruitment
- United States of America
Study participating centre
1775 N. Ursula Street
Aurora
80045
United States of America
80045
United States of America
Sponsor information
Roche Diagnostics Corporation (USA)
Industry
Industry
PO Box 50457
Indianapolis
46256
United States of America
| matthias_axel.schweitzer@roche.com | |
| Website | http://www.roche.com/home.html |
"ROR" |
https://ror.org/011qkaj49 |
Funders
Funder type
Government
State of Colorado Public Health and Environment (USA) (grant ref: 08 FLA 00250)
No information available
National Institutes of Health (NIH) (USA) - Diabetes Endocrine Research Center (grant ref: P30 DK575616)
No information available
National Institutes of Health (NIH) (USA) - General Clinical Research Centers Program (grant ref: M01 RR0069)
No information available
Children's Diabetes Foundation (USA) (grant refs: R01 HL61753, RO1 HL079611 and RO1 DK32493)
No information available
Roche Diagnostics Corporation (USA) - funding from Roche for this research was provided directly to the University of Colorado at Denver Health Sciences Center
No information available
This protocol was written and developed by Satish K. Garg, MD at the Barbara Davis Center for Childhood Diabetes at the University of Colorado at Denver Health Sciences Center (USA).
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | 24/05/2019 | Yes | No |
Editorial Notes
24/05/2019: Publication reference and total final enrolment added.
