Clinical trial NCT03651622: ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development)
Official title: Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Overweight and Obesity
Keywords: Type 1 diabetes
T1D
Type 1 diabetes mellitus (T1DM)
weight management
overweight
obese
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-29
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This initial pilot and feasibility study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management. The study will be done at UNC and Stanford. Sequential randomization will occur at 0, 3.5, and 7 months. Following the baseline measurement visit and two week run-in period, participants will be randomized to one of three diets (stratified by site with block size of 4). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the assigned diet is not acceptable or effective will be re-randomized (or re-assigned if only one diet remains untried). 10.5 months of follow-up time allows for evaluation of the effect of diets on initial weight loss and on early maintenance of initial weight loss. Decision criteria for re-randomization will incorporate clinical outcomes (glycemic control and weight change) and acceptability of the diet.
Primary purpose: TREATMENT

Brief summary: An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches.

COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.

Detailed description: Eight-four participants will be randomized in total; 42 at the University of North Carolina (UNC), 42 at Stanford.

COVID-19 Provisions: Due to impacts of COVID-19, the study was forced to cease recruitment early. 40 subjects were randomized at UNC and 29 were randomized at Stanford, for a total of 69 subjects across sites.

Procedures (methods):

Three distinct dietary approaches will be tested. Dietary approaches are as follows:

Diet 1: hypocaloric, moderate low fat (30% calories from fat) weight management based on the Look AHEAD study Diet 2: hypocaloric, low carbohydrate (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat) Diet 3: advice to select a healthy Mediterranean dietary pattern with no caloric restriction

Participants will complete measurement visits at baseline (-14 days), 3 mos, 6.5 mos, and 10 mos. All visits transitioned to a virtual format as of 6/2020 due to COVID-19 provisions.

Participants will complete a total of 23 intervention sessions over an approximately 10-and-a-half month period (Eight longer sessions (teleconference) and 15 telephone check-ins)

Participants will be randomized to one of the three diets for a minimum of a three-and-a-half month period. Re-randomization is possible following the 3 month and/or 6.5 month measurement visits. Re-randomization is based on acceptability of diet (self-report), non-severe hypoglycemic events (self-report), and not achieving significant weight change (defined as losing at least 2% of body weight from previous study visit), and worsening glycemic control (increase in Hemoglobin A1c of \>/= 0.5% from previous study visit). Re-randomization will occur after the 14-day continuous glucose monitoring (CGM) wear period that will be initiated at each measurement visit.

Eligibility criteria: Inclusion Criteria:

* Individuals 19-30 years old at enrollment
* History of Type 1 diabetes for greater than one year
* Latest hemoglobin A1c less than 13%
* BMI of 27-39

Exclusion Criteria:

* Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate
* Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months
* Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.
* Individuals unwilling to follow any of the three study diets
* Individuals who monitor blood glucose less than 3 times a day

Primary outcomes:
measure: Change in Weight - Randomization 1
timeFrame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit
measure: Change in Weight - Randomization 2
timeFrame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit
measure: Change in Weight - Randomization 3
timeFrame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit
measure: Change in HbA1C - Randomization 1
timeFrame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit
measure: Change in HbA1C - Randomization 2
timeFrame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit
measure: Change in HbA1C - Randomization 3
timeFrame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit
measure: Change in Time in Clinical Hypoglycemia - Randomization 1
timeFrame: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit
measure: Change in Time in Clinical Hypoglycemia - Randomization 2
timeFrame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit
measure: Change in Time in Clinical Hypoglycemia - Randomization 3
timeFrame: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit
Secondary outcomes:
measure: Change in Body Fat - Randomization 1
timeFrame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit
measure: Change in Body Fat - Randomization 2
timeFrame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit
measure: Change in Body Fat - Randomization 3
timeFrame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit
measure: Change in Time in Target Glucose Range - Randomization 1
timeFrame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit
measure: Change in Time in Target Glucose Range - Randomization 2
timeFrame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit
measure: Change in Time in Target Glucose Range - Randomization 3
timeFrame: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Elizabeth Mayer-Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: David M Maahs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Hospital, Translational Research Institute
name: Richard Pratley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Igudesman D, Crandell J, Corbin KD, Muntis F, Zaharieva DP, Casu A, Thomas JM, Bulik CM, Carroll IM, Pence BW, Pratley RE, Kosorok MR, Maahs DM, Mayer-Davis EJ. The Intestinal Microbiota and Short-Chain Fatty Acids in Association with Advanced Metrics of Glycemia and Adiposity Among Young Adults with Type 1 Diabetes and Overweight or Obesity. Curr Dev Nutr. 2022 Oct 30;6(10):nzac107. doi: 10.1093/cdn/nzac107. eCollection 2022 Nov.
citation: Corbin KD, Igudesman D, Addala A, Casu A, Crandell J, Kosorok MR, Maahs DM, Pokaprakarn T, Pratley RE, Souris KJ, Thomas JM, Zaharieva DP, Mayer-Davis EJ; ACT1ON Consortium. Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes. Contemp Clin Trials. 2022 Jun;117:106765. doi: 10.1016/j.cct.2022.106765. Epub 2022 Apr 20.