Trial Outcomes & Findings for Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes (NCT NCT01170208)

NCT ID: NCT01170208

Last Updated: 2020-01-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: Twelve week period from week 4 to week 16
• Results posted on: 2020-01-27

Participant Flow

July 2010 to October 2010. Location: Medical Clinic

Participant milestones

Measure	Group I Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting	Group II Type 2 diabetes treated with basalbolus therapy	Group III Type 2 diabetes treated with biphasic insulin.
Overall Study STARTED	20	20	6
Overall Study COMPLETED	14	20	4
Overall Study NOT COMPLETED	6	0	2

Reasons for withdrawal

Measure	Group I Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting	Group II Type 2 diabetes treated with basalbolus therapy	Group III Type 2 diabetes treated with biphasic insulin.
Overall Study Withdrawal by Subject	5	0	1
Overall Study Protocol Violation	1	0	1

Baseline Characteristics

Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes

Baseline characteristics by cohort

Measure	Group I n=20 Participants Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting	Group II n=20 Participants Type 2 diabetes treated with basalbolus therapy	Group III n=6 Participants Type 2 diabetes treated with biphasic insulin.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	38 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Age, Continuous	44 years STANDARD_DEVIATION 12 • n=5 Participants	60 years STANDARD_DEVIATION 7 • n=7 Participants	55 years STANDARD_DEVIATION 7 • n=5 Participants	52 years STANDARD_DEVIATION 12 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	6 participants n=5 Participants	46 participants n=4 Participants
Weekly Mean Blood Glucose	176.9 mg/dL STANDARD_DEVIATION 28.3 • n=5 Participants	164.9 mg/dL STANDARD_DEVIATION 37.6 • n=7 Participants	190.8 mg/dL STANDARD_DEVIATION 47.0 • n=5 Participants	172.4 mg/dL STANDARD_DEVIATION 35.0 • n=4 Participants
HbA1c	8.4 percent STANDARD_DEVIATION 0.6 • n=5 Participants	8.3 percent STANDARD_DEVIATION 0.8 • n=7 Participants	9.1 percent STANDARD_DEVIATION 1.5 • n=5 Participants	8.4 percent STANDARD_DEVIATION 0.8 • n=4 Participants
Fructosamine	349 µM STANDARD_DEVIATION 46 • n=5 Participants	273 µM STANDARD_DEVIATION 30 • n=7 Participants	270 µM STANDARD_DEVIATION 33 • n=5 Participants	303 µM STANDARD_DEVIATION 53 • n=4 Participants

PRIMARY outcome

Timeframe: Twelve week period from week 4 to week 16

Population: Per Protocol

Outcome measures

Measure	Group I n=14 Participants Type 1 diabetes treated with basal-bolus insulin the	Group II n=20 Participants Type 2 diabetes treated with basal bolus therapy	Group III n=4 Participants Type 2 diabetes treated with biphasic insulin
Change in Weekly Mean Blood Glucose From Week 4 to Week 16	4.6 mg/dL Standard Deviation 29.3	8.1 mg/dL Standard Deviation 51.0	29.5 mg/dL Standard Deviation 17.1

SECONDARY outcome

Timeframe: Twelve week period from week 4 to week 16

Outcome measures

Measure	Group I n=20 Participants Type 1 diabetes treated with basal-bolus insulin the	Group II n=20 Participants Type 2 diabetes treated with basal bolus therapy	Group III n=6 Participants Type 2 diabetes treated with biphasic insulin
Reduction in HbA1c.	0.1 percentage of A1c Standard Deviation 0.8	0.6 percentage of A1c Standard Deviation 0.9	1.3 percentage of A1c Standard Deviation 1.4

SECONDARY outcome

Timeframe: 12 week period from Week 4 to Week 16

Outcome measures

Measure	Group I n=20 Participants Type 1 diabetes treated with basal-bolus insulin the	Group II n=20 Participants Type 2 diabetes treated with basal bolus therapy	Group III n=6 Participants Type 2 diabetes treated with biphasic insulin
Reduction in Fructosamine.	-4.2 µM Standard Deviation 29.2	10.2 µM Standard Deviation 32.2	37.0 µM Standard Deviation 20.9

SECONDARY outcome

Timeframe: January 2011

Outcome measures

Measure	Group I n=20 Participants Type 1 diabetes treated with basal-bolus insulin the	Group II n=20 Participants Type 2 diabetes treated with basal bolus therapy	Group III n=6 Participants Type 2 diabetes treated with biphasic insulin
Incidence of Severe or Serious Hypoglycemia.	0 Participants	0 Participants	0 Participants

Adverse Events

Group I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group III

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Bergenstal

International Diabetes Center

Phone: 952-993-3796

Email: richard.bergenstal@parknicollet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place